Spring 2014

Journal of
Orthopedics for Physician Assistants
Journal Mission
The Journal of Orthopedics for Physician
Assistants (JOPA) is an academic resource created to
deliver ongoing orthopedic education for physician
assistants. The journal is a unique forum to share
our knowledge and experiences with colleagues in
the profession. JOPA strives to publish timely and
practical articles covering all subspecialties. Each
article is peer reviewed to ensure accuracy, clinical
relevance, and readability.
Dagan Cloutier, PA-C, Editor in Chief
Ryan Ouellette, Webmaster, thejopa.org
Charles D. Frost, DHSc, PA-C Content Editor
Spectrum Marketing, Journal Design
Orthopedic Publishing Resources, LLC, Publisher
Contents
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6
14
16
19
Message from the Editor
History of ACL Reconstruction
Creating Your CV
When you Assist You Assist!
Writing for JOPA
Information for Authors
Monthly Image Quiz Follow-up
22
23
24
Anterior Inferior Illiac Spine Avulsion Fracture
Erythema migrans
Slipped Capital Femoral Ephiphysis
25
Slipped Capital Femoral Epiphysis
Physician Assistant
Review Board
Marlon Alexander
Rosharon, TX
Corey Anderson
Harrisburg, SD
Brian Barry
Portsmouth, NH
David Beck
Pittsburgh, PA
Heidi Bolgren
Edina, MN
Ryan Brainard
Savannah, GA
Afton Branton
Geneva, NY
Molly Buerk
Aurora, CO
Mark Carbo
Alexandria, LA
Ray Carlson
San Diego, CA
Jeff Chambers
Athens, Georgia
Larry Collins
Tampa, FL
Michael Cremins
Hartford, CT
Greg DeConciliis
Boston, MA
Charles Dowell
Vancouver, WA
Caitlin Eagen
Boston, MA
Sophie Ellis
Vancouver, WA
Marcie Fitzgerald
Erie, PA
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Erich Fogg
York, ME
Charles D. Frost
Norfolk, VA
Bruce Gallio
Reno, NV
Angela Grochowski
Horsham, PA
Michael Hollopeter
Houston, TX
Jennifer Hartman
Peoria, AZ
Michael Harvey
Fishers, IN
Sean Hazzard
Boston, MA
Matt Henry
Rapid City, SD
Tim Holmstrom
Pullman, WA
Mike Houle
Hartford, CT
Alan Johnston
Nashua, NH
Stuart Jones
Brentwood, TN
Jason Katz
Philadelphia, PA
Jill Knight
Seattle, WA
Stanley Kotara
Lubbock, TX
Kathleen Martinelli
Durham, NC
Sean Metz
Buffalo, VA
Ronald McCall
Springfield, MO
Patrick McCarthy
Manchester, NH
Randall Pape
USAF Academy, CO
Keith Paul
Greensboro, NC
Jason Rand
Boston, MA
Robert Rogan
Poughkeepsie, NY
Scott Walton
Caribou, ME
Todd Rudy
Wellsboro, PA
Bradford Salzmann
Ware, MA
Jeffrey Sommers
Marietta, OH
Steve Steiner
Manchester, NH
Wendi Martin
Stewart
Houston, TX
Lori Tappen
Dallas, TX
Timothy Thompson
Naples, FL
Mary Vacala
Savannah, GA
Courtney Van
Arsdale
Boston, MA
Marcos Vargas
Flushing, MI
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Message from the Editor
This issue, Volume 2, Issue 2, represents the fourth issue of the journal to date. JOPA continues to have
a strong following with nearly 2,300 subscribers and growing. The average open rate for JOPA emails is an
impressive 45% compared to the average industry rate of 20%. This shows that our colleagues are interested
in maintaining a high competency level in orthopedics by reading JOPA. Our level of knowledge is recognized
by our supervising physicians who trust us to make patient care decisions independently. We have worked
hard, gained their trust, and now the profession is thriving.
The resources have been put in place to continue offering free quarterly journal issues and monthly
image quizzes to all orthopedic PAs. A collective effort from all contributors is truly what makes JOPA a
success though. I hope more orthopedic PAs recognize the value of JOPA and the effort being put forth by
everyone involved. JOPA provides a unifying voice for all PAs who practice in orthopedics. Sharing your
knowledge and experience with colleagues will help advance our profession.
Dagan Cloutier, PA-C
JOPA Editor in Chief
Join the JOPA Editorial Board
All articles submitted to JOPA are reviewed
by the Editor in Chief, who is responsible for
deciding whether an article is accepted, rejected,
or in need of revision before publication. JOPA
will be forming an editorial board by subspecialty.
Each subspecialty section will be represented
by a physician assistant or section editor whose
knowledge and experience lies within the chosen
subspecialty. Each section editor will review
submitted articles within their subspecialty prior
to publication and send articles to a group of peer
reviewers who share knowledge and experience in
the subspecialty. Once peer reviewed, authors will
have the opportunity to revise their article and
re-submit for publication. This will ensure that all
articles published in JOPA are accurate, clinically
relevant, and readable. Anyone interested in joining
the editorial board should email, Dagan Cloutier,
Editor in Chief, at [email protected].
4
JOPA
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ACL Reconstruction
History and Current Concepts
Sean Hazzard, PA-C
Massachusetts General Hospital
Boston, MA
Anterior cruciate ligament (ACL) ligament injuries of the knee are a common injury in sports medicine.
Before advances in arthroscopy and surgical techniques an ACL tear was considered a career ending injury
for many athletes. Since the 1990’s there has been a surge in arthroscopic ACL surgery and improved
techniques. Today’s athletes can expect a pre-injury level of stability and function after ACL reconstruction.
Procedures have come a long way by learning from both the success and failures of prior surgical options.
This article will review the evolution of treatments and provide an important historical perspective.
Early 20th Century
During the early 20th century, orthopedic surgeons
generally treated ACL tears with primary repair or extraarticular reconstruction. Attempts to treat ACL injuries
by primary repair focused on re-attaching the ACL to its
native femoral attachment. In 1895, the first ACL repair was
performed by A.W. Mayo Robson1, but was not formally
documented until 1903. The first described repair was in
1900 by W.H. Battle2 of Britain. In 1903, German physician
F. Lange described the first ‘replacement’ of the ACL3
utilizing silk attached to a hamstring (semitendinosus).
This procedure, however, was not successful.
Primary repair was the main treatment option
when the injury was actually recognized until 1917
when Ernest Hey Groves performed and described the
first ACL reconstruction using the iliotibial (IT) band4.
Groves felt that direct repair with suture would “have
been utterly impossible” with a torn ACL. He used a large
U-shaped anterior incision and harvested a strip of IT
band while leaving the tibial insertion intact. A lateral
femoral condyle tunnel was made, and the IT band was
passed through the condyle into the notch. The graft was
then passed through an anteromedial tibial tunnel extraarticuarly and re-routed up to attach to the medial condyle
using an ivory nail. His results were published in 1920
which described the first 14 cases of his reconstruction5.
Four patients returned to all activities, four had ‘some
improvement’, four had no benefit, and no patients were
made worse. Two others were still in rehabilitation at
the time of the publication. Groves also documented his
findings of forward displacement of the tibia with ACL
injuries in his report.
The first time the patella tendon was described
as a graft choice was in 1936 by Willis C. Campbell6. He
described using the medial one-third of the patella tendon
(left attached distally) and a portion of the quadriceps
tendon that would be passed through both a tibial and
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Figure 1: Harry B. Macey 1939
Semitendinosus ACL reconstruction
femoral tunnel. The graft was fixated at the
femoral tunnel exit by suturing it to periosteum.
This technique did not become popular until
nearly 40-50 years later when it was modified and
used for intraarticular techniques. In 1939, Harry
B. Macey described using the semitendinosus
tendon for ACL reconstruction7 where he left
the distal hamstring attached and then routed it
through a tibial and femoral tunnel (Figure 1).
Late 20th Century
Despite the number of advances with ACL treatments in the first half of the century, some questioned
whether the ACL needed to be repaired or reconstructed at all. Some surgeons felt the ACL did not need to
be treated if the meniscal and capsular pathology were appropriately addressed8. The long term implication
of the ACL function was not well known at that time, but despite this, surgeons continued to improve ACL
treatments.
In 1963, Kenneth G. Jones described the central one-third patella tendon graft with a patella bone block
leaving the distal end attached. The free end was then passed over the tibial plateau and into a femoral socket
in the anterior aspect of the intercondylar notch and fixed on the periosteum on the lateral femur. Eleven
cases using this method were reported and deemed successful9,10. In the article, Don H. O’Donoghue pointed
out that the femoral tunnel was in the wrong place and not at the anatomic insertion site on the femur.
However, the technique was simple, caused minimal operative trauma and was a distinct improvement from
other techniques. Therefore, the technique was widely accepted and used at the time.
The Jones technique was modified in 1966 by Helmut Bruckner who took the middle one-third patella
tendon with a patellar bone block leaving the distal end attached. He then passed it through a tibial tunnel,
which provided more graft length, and placed the bone block in a femoral socket. It was fixed with sutures
and a button over the lateral femoral condyle11.
The techniques of Jones and Bruckner were taken one step further in 1969 when Kurt Franke of Germany
described the novel of idea of a free graft without a native attachment12. He used a bone-patella tendon-bone
graft which was fixed with wedge-like pieces of bone at the tibial and femoral attachments. He deemed this
technique successful after nearly 100 cases, with the majority of the patients being soccer players. He was
one of the first to recommend the procedure be done as soon as possible to avoid further cartilage damage
to the unstable knee. He understood that pre-operative cartilage damage was associated with weight bearing
post-operative pain. He also advised patients over the age of 50 years-old against having the procedure.
The 1970’s began a period of extra-articular non-anatomic ACL reconstruction. In 1972, there was a
renewed interest in primary ACL repair. J.A. Feagin13, MacIntosh14, and J.L. Marshall15 presented primary
repair results, most notably being MacIntosh’s “over the top repair” that involved fixing the ACL stump
over the posterior aspect of the lateral femoral condyle. This technique was later modified by Marshall and
became the preferred repair technique.
Procedures were concomitantly being developed to inhibit the anterior and external subluxation of the
tibia while stabilizing the knee in an internally rotated position. Some of these procedures included a pes
anserinus transfer, posterior medial capsular reefing, and an MCL transfer. The “Five-In-One” technique was
The above images were submitted by Charles D. Frost, DHSc, PA-C “These
images are from an open Jones technique, my first ACL reconstruction as a
PA Fellow in Orthopedics in 1986.”
JOPA 7
described by James Nicholas, MD in 1973 and became fairly popular. This involved the three prior procedures
coupled with a medial meniscectomy and vastus medialis oblique advancement16. This procedure reduced
rotational translation but did not provide anterior stability and often led to significant motion loss17,18. Dr.
Nicholas was nationally known at the time for treating ligamentous knee injuries, including multiple operations
on Joe Namath, famed quarterback for the New York Jets. Nicholas and his team at Lennox Hospital in New
York City also developed a brace for Namath’s unstable knee. With surgery and bracing, Namath was able to
return to play with injuries that were considered career ending at the time. The brace designed for Namath
was called the Lenox Hill derotation brace and was later used by thousands of patients with unstable knees.
In 1975, Lemaire described several extraarticular reconstruction techniques19. On the medial side the
gracilis was used to treat MCL injuries. Laterally, the fascia lata was used to reconstruct the ACL by routing it
around the LCL (three additional variations on the technique were developed describing ways to go around
the LCL). Lemaire reported on 453 knees with a 12 month follow-up and reported a 91% success rate. He
concluded that meniscal lesions tended to poorly affect the overall outcome of the ACL surgery. Later on, in
1983, Andrews described a novel extraarticular IT band graft ACL technique20 that focused on the importance
of isometry. He created two slips of the IT band, passed them from distal to proximal in the joint, and then
fixed them extraarticuarly on the lateral femoral condyle. This allowed two separate points of fixation so that
the new ACL could provide stability in both flexion and extension. However, results were inconsistent and
there was a high incidence of arthrofibrosis and occasionally varus instability due to violation of the lateral
structures. The pivot shift was reduced initially, but was not dynamic and tended to stretch and subsequently
fail.
ACL surgery in the 1980’s began to drift away from extraarticular and more on intraarticular, largely due
to the introduction of arthroscopy and the secondary understanding of native attachment points of the ACL.
One of the first to pass the graft intraarticularly was Dr. Insall. The procedure involved detaching a portion of
the distal IT band with a tibial bone block attached. The bone block was then passed posterior to the lateral
femoral condyle, through the posterior capsule, and advance intra-articularly. The graft was then passed
anteriorly through the joint, over the front of the tibia, and fixated with a single screw in a trough at the tibial
tubercle. (Figure 2)21.
This was considered a dynamic stabilization
as the IT band remained attached proximally. As
arthroscopy began to flourish in this decade, surgeons
began to utilize the enhanced visualization to fix the
ACL deficient knee focusing on transitioning from
the ‘over-the-top’ fixation to an ‘outside-in’ (routing a
graft into the joint through a femoral tunnel) as well
as ‘inside-out’ (routing the graft from inside the joint
and into a femoral socket).
With the IT band technique being popular in
the 1970’s, the 1980’s showed a renewed interest in
patella tendon autograft. In 1982, the patella tendon
graft became popular, most notably by WG Clancy22.
While the patella tendon had been described as a
graft choice in the past6, it was not until the late 1980’s
that this became more mainstream. Alternatives to
patella tendon grafts were also investigated further,
particularly the use of the hamstring tendons
(semitendonosus and gracilis). This was attributed
mainly to a 1982 paper by A.B. Lipscomb23 and later
the arthroscopic assisted four-stranded hamstring
autograft technique by M. J. Friedman24.
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Figure 2
The 1980’s also saw the introduction of synthetic grafts. The concept was that with less invasive
techniques coupled with a potentially stronger graft, the success rates would be greater than what was
traditional at that time. Dacron and Gore-Tex synthetic grafts became popular, particularly a polypropylene
graft known as the Ligament Augmentation Device (LAD). However, towards the end of the 1980’s, these saw a
high failure rate with sterile effusions, pain, and instability over time24,25. The synthetic graft trend diminished
fairly quickly due to the high rate of failure.
As the 1990’s began, the technology associated with arthroscopy coupled with the increase in ACL
research saw a surge in ACL surgery, techniques, and subsequently, improved outcomes. One technique
that became the favored procedure was the free bone-tendon-bone graft (central one third of the patella
tendon) which was also known as the “Jones Procedure” after the procedure described in 1963 by Kenneth
Jones9,10. This may be partly due to the paper written by Dr. Kurosaka of Japan in 1987 which showed that the
weakest part of the ACL construct was the fixation and that cancellous screws were superior to other fixation
systems26 (Figure 3A,3B). Particularly in the 1980’s, ACL reconstructions were performed via a two incision
technique (one on the tibia, and one over the superolateral aspect of the femur that exposed the posterior
aspect of the lateral femoral condyle).
Figure 3A
Figure 3B
The 1990’s saw the use of guides and fixation techniques improve along with an increase use of
arthroscopy. This led to intraarticular drilling, which eliminated the need for a second incision27,28. This
was termed the transtibial technique due to the fact that once the tibial tunnel was drilled first, the drill
was then advanced through the tibial tunnel and into the femoral tunnel. This angle made surgeons create
the tibial tunnel slightly posterior to avoid anterior graft impingement in extension. The femoral tunnel was
drilled at the roof of the femoral notch or at the anterior aspect of the lateral femoral condyle. Results of
the technique were excellent compared to previous extraarticular techniques as well as the previous two
incision techniques. The transtibial approach became the gold standard in the 1990’s, when nearly 150,000
ACL reconstructions were performed yearly.
The “endoscopic/transtibial” technique was popularized when several free graft options were developed.
Autograft options included bone tendon bone (BTB) and hamstring tendons (gracilis and semitendinosus).
Allograft options included BTB, hamstring tendons, and posterior tibial tendon grafts. The early 1990’ also
saw the introduction of interference screws, cross pins, and the Smith and Nephew Endo-Button to fixate
the ACL graft in both the femoral and tibia tunnels. Compared to autograft options, allografts have shown a
higher failure rate in young, active patients. BTB and hamstring autografts have become the gold standard in
this population. Recently, quadriceps tendon autografts have started to be utilized and studied further.
JOPA 9
Figure 4: Intraarticular pictures demonstrating a transtibial technique. Note the aperture of the femoral
tunnel to be at the apex of the lateral wall and top of the notch (Proper femoral drill hole location in ACL
reconstruction. Used with permission from James Smith, MD source: www.vumedi.com,).
Figure 5: (Left) Circled is the native ACL attachment
on the lateral femoral wall. (Right) Circled is where a
transtibial approach attaches the ACL graft. (Proper
femoral drill hole location in ACL reconstruction, Used
with Permission from James Smith, MD source: www.
vumedi.com,).
Figure 6: Two femoral tunnels that will hold
the graft for the AM and PL bundles of the
ACL.
21st Century:
In the early 2000’s, Dr. Freddie Fu began investigating attachment sites of the native ACL and the
corresponding transtibial technique tunnels. He found that this technique did not reliably reproduce the
native anatomic landmarks and subsequently altered kinematics compared to the native ACL29,30,31. He showed
that the transtibial technique did improve the anterior stability but did a poor job of controlling rotation. An
increase in anterior translation was also seen postoperatively. He showed that the meniscus would often take
up some of the AP and rotatory stabilization, hence why patients who previously had a large meniscectomy
during their reconstruction often had poor results compared to isolated ACL reconstructions. He made
the point that with this increase in translation both in the AP and rotational directions, that non-anatomic
graft placement could not be discarded as a risk factor for degenerative disease, graft rupture, and further
morbidity.
Fu reviewed CT scans of patients who had prior transtibial reconstructions and correlated it to
the landmarks of the native ACL and found these frequently did not match. He advocated for anatomic
reconstruction of the anterior cruciate ligament and popularized the notion of anatomic double bundle ACL
reconstruction32,33. This involved drilling four independent tunnels (two in the femur and two in the tibia)
and tensioning each bundle independently (Figure 6). The reason for this independent tensioning is because
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the AM and PL bundles are tense at different points in motion (The AM is tight in flexion while the PL is tight
in extension) to ideally control anterior translation as well as rotation43. These produced similar subjective
results at short-term follow-up compared to traditional procedures, but did produce better objective/
kinematic results34,35,36.
Shortly thereafter, Fu began focusing on customized ACL surgery by measuring the footprints of the
native ACL and determining if an anatomic double bundle or anatomic single bundle reconstruction would
most closely reproduce native anatomy. The technical complexity of the double bundle reconstruction
remained a challenge and did not catch on in significant popularity, but the concept of better reproducing
the ACL anatomy during the reconstruction was welcomed.
To meet the concept of reproducing native anatomy with the ease of traditional transtibial techniques,
anatomic single bundle ACL reconstruction became popular around 2008-2010 with different techniques
involving drilling through the anteromedial portal using flexible and rigid reamers (Figure 7A&B), as well as
retrograde reamers. These allowed for use of both bone and soft tissue grafts as well as different configurations
such as hybrid double bundle reconstructions (two femoral tunnels, one tibial tunnel)37-40. These techniques
produced a more reproducible way to create anatomic tunnels and a more objectively stable reconstruction
compared to the previously ‘gold standard’ transtibial technique.
As transtibial reconstruction began to fade
out of favor to the anatomic reconstructions and
anterior medial portal drilling, studies shifted to
compare the anatomic single bundle techniques to
the double bundle reconstruction. Both techniques
showed similar and often improved anterior-posterior
stability. The double bundle technique showed
better rotatory control of the knee compared to the
transtibial technique. Short and mid-term follow-up
show significant success, however long term results
are not yet published. Recently, studies have shown no
significant clinical, subjective, or objective differences
between anatomic single bundle and double bundle
reconstruction41.
7A
Discussion:
ACL reconstruction has seen a development in the
ideals and principles of creating a stable knee, both in
the short term as well as the long term. Each technique
has noted varying results with each evolution building
on the next. Learning from prior techniques (both the
successful and poor) is important to develop the next
generation of treatments for this injury.
7B
Figure 7A&B: A flexible reamer is placed through an
anteromedial approach and is reamed to creat a femoral
tunnel.
JOPA 11
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des plasties ligamentaires en traumatologie sportive, J; Chir (Paris)
(1975); 110: 281-294
40. Hazzard SM, Pearle AD, Anatomic Double-Bundle ACL
reconstruction using the “footprint”/Flexible reamer method,
Techniques in Knee Surgery (2012), Sept Volume 11, Number 3, 161167
20. Andrews JR, Sanders R, A “mini-reconstruction” technique in
treating anterolateral rotary instability (ALRI), Clin Orthop Relat Res
(1983); 172: 93-96
41. Ahlden et al, A Prospective Randomized Study Comparing
Double- and Single-Bundle Techniques for Anterior Cruciate Ligament
Reconstruction. AJSM, November 2013; 41, 2484-2491
21. Insall J, Joseph D, Aglietti P, Campbell R, Bone-block iliotibial-band
transfer for anterior cruciate ligament insufficiency, JBJS Am (1981);
63: 560-569
42.
http://www.nytimes.com/2006/07/17/sports/17nicholas.html?_
r=0. 11/21/13
22. Clancy WG, Nelson DA, Reider B, Narechania RG, Anterior cruciate
ligament reconstruction using one-third of the patella ligament,
augmented by extraarticular tendon transfers, JBJS Am (1982); 64:
352-359
43. Iriuchishima T, et al, In vitro and in vivo AM and PL tunnel
positioning in anatomical double bundle anterior cruciate ligament
reconstruction, Arch Orthop Trauma Surg, August 131 (8): 1085-90,
2011
23. Lipscomb AB, Johnson RK, Synder RB, et al, Evaluation of hamstring
strength following use of semitendinosus and gracilis tendons to
reconstruct the anterior cruciate ligament, AJSM (1982);10, 340-342
12
JOPA
There is a distinction between one qualified PA and another.
It’s called a CAQ.
Now is the time to plan for the 2014 exam!
Sign into your record to register for the CAQ program today.
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Register Now!
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Visit www.nccpa.net/orthopaedicsurgery
or call 678-417-8100I&*/,&4:*-:&%*-/./6&0!"-&
><@&./&C-:3!9*%,.(&D"-6%-0&:!,*02&
Creating Your Curriculum Vitae (CV)
Marcos A. Vargas, MSHA, PA-C
Your Resume or CV is your best “calling card”. It’s paramount that it communicates your expertise
(unique skill set) and professional qualifications succinctly by using descriptive category headings and
other standard industry requirements. In other words, by avoiding typos, using bulleted items list, and
1” margins all around ( minimum ) will not only set you apart, but will give you the best chances if you
implement or incorporate a user-friendly comprehensive format as depicted in the CV sample provided.
Bring to life your outdated resume/CV by using and highlighting your relevant information.
Curriculum Vitae
Outline
Marcos A. Vargas, MSHA, PA-C
2251 Woods West Dr, Flushing, MI 48433 • (810) 659-0435 • [email protected]
CURRENT POSITIONS
EDUCATION
Cross-trained Physician Assistant with 20+ years with strong varied clinical background and proven clinical
& non-clinical competencies. A self-directed, patient centric professional with demonstrated strong analytical &
superb work ethic history. Areas of interests, knowledge & expertise include, but are not limited to the following:
ACADEMIC HONORS
Core competencies:
• Strong leadership skills & statistical literacy
ACADEMIC
APPOINTMENTS
• Published Author in various media: journals /newsletters,
• Excellent Staff / Patient interpersonal Skills
• Excellent Written & Oral Communication Skills
• Consulting Experience
• Great Organization Skills―detail oriented professional
• Seasoned Event /Conference Speaker / Presenter
• Professional Teaching background (college level )
• In-depth knowledge of Clinical Risk Management Techniques and Methodologies
BOARD
CERTIFICATION
HOSPITAL
AFFILIATIONS
Career Highlights & Accomplishments:
Sub-investigator in the Research Study: EMINENCE ( Evaluation of M118 In Percutaneous Coronary
intervention ) @ GRMC, 3/28/08. ( completed )
CURRENT MEDICAL
LICENSURE
Created in-house intra-departmental Newsletter: “The ED Courier” ( Sept. 2005 ).
Developed/created ED rotational ( Physician Assistant students ) manual.
Learned/performed cardiac stress testing post cardiologists’ ED consultations .
PROFESSIONAL
APPOINTMENTS/
OFFICES
Provided first surgical assistance to general & specialty surgeons as a Surgical PA.
Mastered assistive laparascopic skills quickly (i.e. general / Gyn surgical procedures).
Performed a Post-mortem organ procurement cardiectomy @ Sacred Heart Medical Center, Spokane, WA,
( May 25th, 1990 ) for a regional Organ Procurement Agency.
PROFESSIONAL
HONORS
CURRENT
AFFILIATIONS/
Memberships
PROFESSIONAL
ACTIVITIES
Employment History:
•
Orthopedic Physician Assistant, Hurley Medical Center, from 10/08/09 to
•
Cardiology Physician Assistant, Regional Cardiology Associates, Genesys Regional Medical Center,
from 9/11/06 to 9/2/09
•
Emergency Department Physician Assistant, Hurley Medical Center, from 12/95 to 8/9/06
•
General Surgery Physician Assistant, McLaren Regional Med Center, From 11/90 to 12/95
Cardiothoracic Surgical Physician Assistant, Cardiothoracic Assoc. From 1/90 to 8/90
•
14
JOPA
Cardiothoracic Surgical Physician Assistant, Thoracic Surgeons Assoc. From 9/88 to 12/89
HOSPITAL COMMITTEES
Published Works / Non-Clinical Articles:
COMMUNITY ACTIVITIES
PUBLICATIONS - BOOKS/
MANUALS/PUBLICATIONS SCIENTIFIC ARTICLES
Over 56 published credits in various media & 2 unpublished Research Papers since 2008
Professional CV available if needed
_____________________________ Education / Academic Training __________________________
Master in Science Administration (major: Healthcare Administration )
Central Michigan University, MI.
PUBLICATIONS - BOOK
CHAPTERS / BOOK REVIEWS
Bachelor of Science in Health Sciences
University of Alabama – Birmingham ( UAB )
Bachelor of Arts in Biology
Saint Thomas University, Miami, Fl
ARTICLES IN PRESS OR
SUBMITTED
- Certificates - Healthcare Risk Management ( 120 hr graduate certificate)
- Certified Professional Utilization Reviewer ( CPUR / twice )
- Basic Cardiac Life Support ( B.C.L.S.) -- 2014
INVESTIGATIONAL STUDIES
- Advanced Cardiac Life Support ( A.C.L.S.) --2014
- Pediatric Advanced Life Support Systems ( P.A.L.S. )- former
INVITED ORAL
PRESENTATIONS
- Advanced Pneumatic Instrumentations Operative Techniques( Midas-Rex Institute)
- Physician’s/Surgeon’s Assistant Professional Certificate ( UAB)
- The Medico-legal Death Investigator Training Course (Saint Louis University,1996)
_____________________________ Awards / Honors Received:_______________________________
•
Received “The Bone Pin” honorably awarded to staff members for their demonstrated clinical
excellence to a patient/family as part of a team for The Center of Joint Replacement @ Hurley
Medical Center ( Spring 2013 ). Designated honoree selected by in-house patients themselves.
•
Three-time Apple Award Honoree for clinical excellence and corporate role model employee @
Hurley Medical Center ( `96,`98,`2004 )
•
Recognized consecutively for two years (’93-’94 ) for perfect work attendance @ McLaren
Regional Medical Center by HR dept. Currently with over a 48 month perfect work attendance record
too.
•
Twice (`96,`97 ) recognized for perfect work attendance @ Hurley Medical Center by HR dept.
•
Listed with biographical citation in (’92-’93) in Who’s who Among Young Professionals Directory
•
Awarded Weck Scholarship for best qualified upcoming representative of the PA profession
among classmates ( ’87 @ UAB).
________________ Key Qualifications /Auxiliary Skills/ Community Service:___________
- Editor/Designer ( logo creator ) & Publisher of AAPA-LM’s Newsletter & brochure
- JAAPA Peer Review Advisory Board Member(provided blinded manuscripts critiques)
- Bilingual ( dual fluency: English & Spanish – orally & written/Portuguese-reading ).
- MSO Applications Literacy ( 2003 - Excel / Power Point /Word ).
- Basic Project Planning/Management literacy & experiences
- Self-taught basic Desktop Publishing Techniques ( personal hobby ).
- Intermediate Statistical Literacy / Outcomes-research oriented clinician.
- Board of Directors Member for Michigan Academy of Physician Assistants ( 2011-13 )
- Co-organized a local food drive with (local) charitable organization for the needy in commemoration of
National Physician Assistant Day (October 6th, 1994 ).
- Volunteered & performed pre-summer camp screening physical exams for abused & socio-economically
disadvantaged children in Spokane, WA, 1990.
JOPA 15
When You Assist, Assist Fully!
Reza Ghadimi, PA
Albuquerque, NM
“I like it when you help me, Reza” Al Rosen use to say “you don’t talk a lot and you don’t suck a lot.”
Al Rosen was a legendary doctor and an avid skier in Taos, NM. An all around country doctor and surgeon,
he practiced the old way. He made house calls, held patient’s hands when he talked to them, and knew
everyone by their first name. He first came to Taos in the late 1930’s. Dr. Rosen, along with Dr. Pond and Dr.
DeVeaux, became the corner stone of medicine in Taos and Northern New Mexico. Although Al Rosen was
not a board certified surgeon of any kind, he did most of the surgical cases and obstetrics in Taos in those
days. Before I arrived in Northern New Mexico in the early 1970s no other PA had assisted him. Many
young residents from UNM School of Medicine rotated through Taos and often helped Dr. Rosen in surgery.
I met Dr. Rosen soon after arriving in the area. When he learned of my surgical and orthopaedic
background he asked me to work with him. My knowledge of traction setup also helped keep patients at our
local hospital and prevented them from being transferred away from home. Shortly after however, Steve
Halmstad, PA, joined his practice and became his primary surgical assistant. Steve Halmstad was a great
PA and a good friend. A graduate of the Medex program and an Ex Special Forces Medics. Steve died in
2001 from cancer. I miss him - even today.
Al’s surgical room was always quiet. He did not like anyone to turn on the radio, listen to music, or
talk loud in his operating suite. “The auditory nerve is not anesthetized!” he used to say. “Un-necessary
noises can cause subconscious anxiety and the patient will dislike the surgical experience. By keeping
quiet and paying attention to our work, the surgery will have a more positive and rewarding outcome.”
FIGURE 1. OVERHEAD TRACTION SET UP PER ARMY/AIR FORCE
MANUAL CIRCA 1960’S.
16
JOPA
Al Rosen was of the opinion that most of the younger doctors who assisted him wanted to constantly do
something, thus they ended up hindering rather than helping him. “They pull the wound toward themselves
so that they can see better” Al used to say “and in the zeal of doing something they constantly use the
suction tube even when there is nothing to suck and block my view. I have to almost fight them to do the
surgery.”
On the ski slopes of Taos Mountain however, Al was a daredevil. Flying down black diamond runs
and around hairpin turns, made him a different kind of a legend. Hard to believe that such a mild mannered
doctor was such a risk taker. He was such a regular presence on the ski slopes that they named one of the
black diamond runs after him. “Al’s run” challenges many expert skiers, even today. In his later years, he
was often seen skiing down the slopes wearing an oxygen tank and mask. Al Rosen died in October of 1982
but his legacy lives on. I learned a lot from Al Rosen and others like him.
When I first entered the operating room at the ripe age of fourteen, I was shaking with excitement
and fear. Excitement for entering such a sacred realm and fear of screwing something up. I was given the
job by Dr. Azïm, a friend of my father who was a part owner of a private hospital in our town. (See my
article; “Of powder plaster, overhead traction, and broomstick prosthesis in the October 2013 issue of
JOPA.) He became my benefactor and like Al Rosen, his devotion to his work, strong regard for his patients,
and love of teaching was the greatest gift I received during the early days of my medical career. He often
told me, “it is harder to assist than to do the surgery because the assistant must think twice. First he must
realize what the surgeon is doing and then act accordingly to help him accomplish it.”
“Don’t watch me,” he would start “watch my hand, watch where I put the instrument, the needle, the
suture. What is the purpose of my action and what can you do to improve it’s outcome.”
So it was then I got introduced to Dr. Azïm’s assistant; Ibrahïm. He was a burley, kind looking
middle aged and stoutly religious gentleman who had been working with Dr. Azïm ever since he opened his
private hospital. Ibrahïm was - for all practical purposes illiterate. He read very poorly and could not write
to save his life. But he knew and could identify every part of the intestines and abdominal tissue. Over
the years he had watched intently his operating surgeon’s every move and had seen his share of successes
and failures. Watching the two of them was a treat, as though only one brain moved those four hands in
concert. Ibrahïm started every procedure with a prayer - quietly, under his breath, he would pray for the
safety of the patient and his/her rapid recovery. I learned so much from him that helped me cope with
many challenges of ever day medicine through the rest of my career. “The human body is sacred,” he use
to say “the very breath of God has given it life, treat it with reverence and respect and it will repay you by
healing well.”
Years later and halfway around the world, I had an opportunity to be involved in the FDA clinical
trials of the Osteonics (cement-less) porous coated press-fit stem hip implants. I moved to Lubbock, Texas
in the late 80s to assist with the process by helping an Osteonics recruited orthopaedic surgeon there.
While living and working there, I got to work with several orthopaedic surgeons. I came to know and highly
respect one particular physician (not the one in the trials.) He was a doctor from India named; Gurdev Gill.
He used very few instruments to do his surgeries, was very fast and accurate and had remarkable results.
He was of the philosophy that instruments injured the tissue and one should be cognizant of their use - a
strange thing to hear from an orthopaedic surgeon who cut bone and tissue and replaced them with metal
and plastic. Yet there it was. His patients recovered faster and better than many other surgeons I worked
with. In that job, I also was trained and acted as a salesman for Osteonics, thus got a good understanding of
the mentality of the world of medical device sales and business.
One reward of assisting many doctors is that you appreciate the difference between good surgeons
and the others. This can teach you a lot of medicine. The process of assisting many surgeons with
different ideologies and techniques can make the job of a PA difficult. However, seeing different approaches
to a problem is a powerful learning tool. The PA’s knowledge of the different approaches becomes very
helpful when problems arise and can make the PA a valuable member of the surgical team. However, the
job of the PA is not, and should not be, just assisting the surgeon in the procedure. First and for most,
the PA must be mindful of the patient’s well-being. A good assistant should familiarize him/ herself
with the patient’s health status like allergies, medications, other medical and social issues, etc. It is the
responsibility of the assistant to make sure that the patient has been prepped and readied for the surgery
properly.
JOPA 17
I was once called to replace an assistant who did not show for a case. The surgical procedure was
a laminectomy on an elderly lady. I got there a bit late and hastily scrubbed and entered the OR. I had
assisted that particular surgeon before and I knew him to be a competent spine surgeon. When I joined
him, he had already made the incision and was placing the microscope over the incision site to proceed
with the laminectomy. I dutifully joined him and we proceeded with the surgery. When the laminae was
exposed, it did not look particularly injured but I said nothing since many such tissues do not necessarily
look damaged. We were at the correct level but still something bothered me throughout the procedure.
The surgery went well and we closed the wound and the patient was awoken. As she was being rolled out
of the room, the surgeon stopped everyone and made some expletive comments that we had operated on
the wrong side. The patient was rolled back in, put back under anesthesia and we proceeded to remove
the lamina on the other side. Although the surgery was successful, the surgeon accepted all responsibility
and the patient was gracious enough not press any charges. I felt that somehow I neglected my duty and let
the patient and the surgeon down. Had I taken a moment to note the procedure for which I was assisting
as I was scrubbing for it, I could have noticed the error. Since then, I make it a point to always familiarize
myself with the case I am about to assist on. Especially if I am in an unfamiliar, unusual, unscheduled, or
unknown situation.
I strongly feel that the PA should be completely familiar with the case he or she is about to assist in.
Especially if he/ she is helping a surgeon in a different practice. That includes making sure the lab work is
done, the patient has been cleared by the medical team, and that the anesthesiologist is fully aware of the
patient’s condition - good or otherwise.
A particular gripe of mine is the freedom given to orthopaedic salesmen who are allowed or even
invited into the surgical suites. As I mentioned above I actually worked as an Orthopaedic salesman for a
while and have a first hand knowledge of their mind set. I have seen some of these sales people go in and
out of the surgical suites at will, flirt with people in the room, even hand instruments and move around the
surgical room freely. It is true that many of them are previous scrub techs, nurses, PAs, or doctors. But
at their present position they are salesmen and may not be mindful of their doings. If the surgeon is lax
or unaware of these people’s activities, it is the responsibility of the assisting PA to bring it to his or her
attention.
If you are like me and assist many surgeons, I strongly recommend that you keep an assistant’s
version of an op-report. If for whatever reason, a particular case goes sour and problems arise you may be
called to testify in front of the hospital board, Medical Board, malpractice board, or jury. You would look
very professional and blameless if you show up prepared with clear and concise documents. When a case
runs into trouble, it may not go to a hearing or a trial for months or even years after the day of incident.
Not much credit is placed on testimonies given from memory. By having your own report, you can best
help your case, the surgeon’s and the patient’s.
I have served on the “Medical Board” and “Medical Review Commission” of my state for many years.
I have served as a hearing officer, expert witness, judge and jury on many such cases. The plaintiff lawyers
do not care or often even allow circumstantial evidence contributing to the outcome. As far as they are
concerned the surgeon is responsible for everything that happens in that room - end of story!
Over the years I have precepted many PA student. I try to impart this knowledge that was taught
to me over the years. To my students I say; “when you assist, assist fully and be cognizant of the patient’s
well-being.” Be gentle to the tissue you are working on, especially if the doctor you are assisting is rough
in his work.” “Be kind to the tissue and the tissue will be kind to you and heal well.” Also be aware of your
work environment and do not hesitate to point out conflicts, discrepancies or problems, even if you make
others uncomfortable. This is especially hard when those you reprimand are your friends. But do not ever
forget that your primary role as an assistant is the well-being of the patient not your co-workers.
Be good to your patients and they will like you. People who like you won’t sue you!
18
JOPA
Writing for JOPA: Information for Authors
The Journal of Orthopedics for Physician Assistants (JOPA) is a
peer-reviewed publication that delivers a broad range of orthopedic
content across all subspecialties. Authors can contribute any original
article that promotes an orthopedic education for physician assistants
(several examples are listed below). JOPA avoids publishing original
research articles, as well as articles previously published or being
considered for publication in other journals. Articles are peer reviewed
by a panel of orthopedic physicians and PAs to ensure accuracy, clinical
relevance, and readability.
References should be cited using the AMA Manual of Style, 10th edition. References should be recent and
predominately drawn from peer reviewed journals. Textbook and website references should be avoided if possible.
Article content, including the manuscript body and any tables, should be submitted in Microsoft Word format to
facilitate editing. Please use a standard font, such as Times New Roman, and a 12-point font size. Use appropriate
headings and subheadings in feature articles to organize paragraphs. JOPA reserves the right to edit content for space
and/or grammar issues. Any images that accompany an article must be sent as separate downloadable files from the
manuscript text for publishing.
Featured Review Articles
Featured review articles should contain a comprehensive
review of literature on an orthopedic topic of choice.
These academic literature reviews should be heavily
referenced and may be co-authored. Subspecialists
should consider writing on topics in their fields of
expertise. Featured review length should be 4-8 pages.
When considering the appropriate length, keep in mind
the clinical significance and readability of content.
Review Articles
Review articles should be 3-4 pages on an orthopedic
topic of choice. Review articles should be selective and
include few references. Authors may review a clinical
condition, surgical procedure, or any other topic related
to orthopedics. Preceptors may consider co-authoring a
review article with a PA student interested in pursuing a
career in orthopedics.
Case Studies
Case studies choose a case and provide a complete
history of the clinical presentation, treatment, and
outcome. Radiographs and other imaging should
be included to follow the course of a diagnosis and
treatment. Several learning points should be included at
the end of the case study, with appropriate references.
Please remove all patient identification information prior
to submission.
Case Reviews and Image Quizzes
Case reviews present a unique case with several images
and a brief description of the presentation, diagnosis,
and treatment. Image quizzes include an image for
readers to interpret. Answers should be provided, with
a brief explanation of the patient and correct diagnosis.
Do not include literature review or references for case
reviews or image quizzes.
Be Creative!
Consider submitting a description of how your practice
uses PAs or the relationship you have with your
supervising physicians. Consider writing on a patient’s
experience and how it could be of value to PA colleagues.
Write a detailed narrative of a typical day in your life as
a PA. Personal experiences can be some of the most
interesting and helpful articles for other PAs to read. If
you have any other submission ideas, please contact the
editor at [email protected].
Supervising Physicians and
Allied Health Professionals
Supervising physicians may submit articles on topics in
their subspecialty or issues related to the PA profession.
Physicians may also choose to write on a procedure or
service unique to their practice. Co-authoring an article
with a supervising physician is a great way to promote
the physician-PA relationship. Nurse Practitioners
practicing in orthopedics are encouraged to contribute,
and may receive a free copy of JOPA by contacting
the editor or subscribing online. Contributions from
other allied health professionals, such as physical
therapists and athletic trainers, give PAs an opportunity
to learn from those with whom we share patient care
responsibilities. Allied health professionals who wish
to contribute to JOPA can contact the editor, Dagan
Cloutier, at [email protected].
JOPA 19
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IMPORTANT SAFETY INFORMATION
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©2013 Ferring Pharmaceuticals Inc.
20
JOPA
01/13
EUF-C21717
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Please see brief summary of Prescribing Information
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BRIEF SUMMARY
Please consult package insert for full Prescribing Information.
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Do not use EUFLEXXA to treat patients who have a known hypersensitivity to hyaluronan preparations; Do not use
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GENERAL
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been assessed in humans; Safety and effectiveness of injection in conjunction with other intra-articular injectables,
or into joints other than the knee has not been established; Remove any joint effusion before injecting; Transient pain
or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA; Do not use after expiration
date; Protect from light; Do not re-use—dispose of the syringe after use; Do not use if the blister package is opened
or damaged.
Information for Patients
Provide patients with a copy of the Patient Information prior to use; Transient pain and/or swelling of the
injected joint may occur after intra-articular injection of EUFLEXXA; As with any invasive joint procedure, it is
recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing
activities such as jogging or tennis within 48 hours following intra-articular injection; The safety of repeated
treatment cycles of EUFLEXXA has been established up to 1 year.
Use in Specific Populations
Pregnancy: The safety and effectiveness of EUFLEXXA have not been established in pregnant women.
Nursing Mothers: It is not known if EUFLEXXA is excreted in human milk. The safety and effectiveness of EUFLEXXA
have not been established in lactating women. Children: The safety and effectiveness of EUFLEXXA have not been
demonstrated in children.
ADVERSE REACTIONS
Adverse event information regarding the use of EUFLEXXA as a treatment for pain in OA of the knee was available
from two sources; a 12 week multicenter clinical trial conducted in Germany, and a 26 week multicenter clinical trial
conducted in the US.
Reported Device-Related Adverse Events
The most common adverse event related to EUFLEXXA injections reported in the clinical studies are the
following: Arthralgia; Back pain; Pain in extremity; Musculoskeletal pain; Joint swelling. All adverse events related
to EUFLEXXA injections reported in Tables 1, 2, 3 and 4.
Potential Adverse Events
The following adverse events are among those that may occur in association with intra-articular injections:
Arthralgia; Joint swelling; Joint effusion; Injection site pain; Arthritis
12 Week Multicenter Clinical Study
This clinical investigation was a prospective randomized, double-blinded, active control (commercially available
hyaluronan product) study conducted at 10 centers. Three hundred twenty-one patients were randomized into
groups of equal size to receive either EUFLEXXA (n=160) or the active control (n=161).
A total of 119 patients reported 196 adverse events; this number represents 54 (33.8%) of the EUFLEXXA group
and 65 (44.4%) of the active control group. There were no deaths reported during the study. Incidences of each event
were similar for both groups, except for knee joint effusion, which was reported by 9 patients in the active control
group and one patient in the EUFLEXXA treatment group. Fifty-two adverse events were considered device-related.
Table 1 lists the adverse events reported during this investigation.
Table 1. Incidence of Adverse Events Reported by >1% of Patients
Patients, n (%)
Body System
ADE
EUFLEXXA
Active Control
(n = 160)
(n = 161)
Gastrointestinal
Nausea
3 (1.88)
0
disorders
General disorders and
Fatigue
2 (1.25)
0
administration site
Infections and
Bronchitis
1 (0.63)
2 (1.24)
infestations
Infection
2 (1.25)
0
Investigations
Blood pressure
6 (3.75)
1 (0.62)
increased
Arthralgia
14 (8.75)
17 (10.6)
Arthrosis
2 (1.25)
0
Musculoskeletal,
Back pain
8 (5.00)
11 (6.83)
connective tissue
Joint disorder
2 (1.25)
2 (1.24)
and bone
Joint effusion
1 (0.63)
13 (8.07)
Joint swelling
3 (1.88)
3 (1.86)
Pain in limb
2 (1.25)
0
Tendonitis
3 (1.88)
2 (1.24)
Nervous system
Headache
1 (0.63)
3 (1.86)
disorders
Paresthesia
2 (1.25)
1 (0.62)
Respiratory, thoracic
Rhinitis
5 (3.13)
7 (4.35)
and mediastinal
Skin and subcutaneous
Erythema
0
2 (1.24)
tissue disorders
Pruritus
0
3 (1.86)
Vascular disorders
Phlebitis
0
2 (1.24) .
A total of 160 patients received 478 injections of EUFLEXXA. There were 27 reported adverse events
considered to be related to EUFLEXXA injections: arthralgia – 11 (6.9%); back pain – 1 (0.63%); blood
pressure increase – 3 (1.88%); joint effusion – 1 (0.63%); joint swelling – 3 (1.88%); nausea – 1 (0.63%);
paresthesia – 2 (1.25%); feeling of sickness of injection – 3 (1.88%); skin irritation – 1 (0.63%); tenderness
in study knee – 1 (0.63%). Four adverse events were reported for the EUFLEXXA group that the relationship to
treatment was considered to be unknown: fatigue – 3 (1.88%); nausea – 1 (0.63%).
Table 2. Relationship of Adverse Effects to Treatment Groups That Were Considered to Be Treatment Related
(EUFLEXXA)
Commercially Available
Hyaluronan Product
Adverse Event
(Number of Reports)
(Number of Reports)
n = 160
n = 161
Arthralgia
11
9
Back pain
1
0
Baker’s cyst
0
1
Blood pressure increase
3
0
Erythema
0
1
Inflammation localized
0
1
Joint effusion
1
9
Joint swelling
3
2
Nausea
1
0
Edema lower limb
0
1
Paresthesia
2
0
Pruritus
0
1
Sickness
3
0
Skin irritation
1
0
Tenderness
1
0
TOTAL
27
25
©2013 Ferring Pharmaceuticals Inc.
26 Week Multicenter Study
This was a multicenter, randomized, double-blind trial evaluating the efficacy and safety of EUFLEXXA, as compared
with saline, in subjects with chronic osteoarthritis of the knee followed by an open labeled safety extension study.
The intervention consisted of three (3) weekly injections of study device into the target knee, with scheduled
follow-up evaluations during the 26 weeks following the first injection. In the extension phase subjects received three
(3) weekly injections of EUFLEXXA into the target knee with follow-up evaluation up to 52 weeks. Table 3 shows the
treatment-emergent adverse events by preferred term with an incidence of ≥ 2% among treatment groups.
Table 3: Treatment-Emergent Adverse Events (TEAEs) by Preferred Term with an Incidence of > 2% among the
Treatment Groups (Safety Population)
Extension
Study Repeat
Injection for
26 Week FLEXX Study (Core)
52 Weeks*
All Treatments
Saline
EUFLEXXA
EUFLEXXA
System Organ Class
N = 588
N = 295
N = 293
N = 219
Preferred Term
n (%)
n (%)
n (%)
n (%)
Any TEAE
326 (55.4)
169 (57.3)
157 (53.6)
96 (43.8)
Musculoskeletal and connective tissue disorders
Arthralgia
62 (10.5)
35 (11.9)
27 (9.2)
19 (8.7)
Back pain
23 (3.9)
11 (3.7)
12 (4.1)
6 (2.7)
Pain in extremity
13 (2.2)
10 (3.4)
3 (1.0)
3 (1.4)
Musculoskeletal pain
10 (1.7)
4 (1.4)
6 (2.0)
2 (0.9)
Osteoarthritis
9 (1.5)
7 (2.4)
2 (0.7)
0
Joint swelling
8 (1.4)
4 (1.4)
4 (1.4)
6 (2.7)
Infections and infestations
Upper respiratory
23 (3.9)
11 (3.7)
12 (4.1)
6 (2.7)
tract infection
Nasopharyngitis
17 (2.9)
13 (4.4)
4 (1.4)
10 (4.6)
Sinusitis
16 (2.7)
10 (3.4)
6 (2.0)
5 (2.3)
Urinary tract infection
12 (2.0)
6 (2.0)
6 (2.0)
3 (1.4)
Injury, poisoning, and procedural complications
Injury
17 (2.9)
9 (3.1)
8 (2.7)
9 (4.1)
Nervous system disorders
Headache
17 (2.9)
11 (3.7)
6 (2.0)
3 (1.4)
Gastrointestinal disorders
Diarrhea
14 (2.4)
2 (0.7)
12 (4.1)
3 (1.4)
Nausea
12 (2.0)
7 (2.4)
5 (1.7)
4 (1.8)
Respiratory, thoracic, and mediastinal disorders
Cough
10 (1.7)
3 (1.0)
7 (2.4)
3 (1.4)
Vascular disorders
Hypertension
18 (3.1)
5 (1.7)
13 (4.4)
1 (0.5)
*Treatment group for repeat study are for subjects who received EUFLEXXA in both the core and extension
(219 out of 433).
N = number of subjects in a given treatment group for the population analyzed; n = number of subjects reporting
at least one adverse event within system organ class/preferred term; (%) = percentage of subjects based on N;
TEAE = treatment-emergent adverse event.
Note: An adverse event was counted as a TEAE if it was either not present at baseline (prior to the first dose of
double-blind study device) or present at baseline but increased in severity during the treatment period.
During the initial randomization/treatment phase, 326 (55.4%) subjects in the safety population experienced 742
TEAEs. The proportion of subjects reporting TEAEs was generally similar in the EUFLEXXA and saline groups (53.6%
and 57.3%, respectively). The most common preferred term of TEAE was arthralgia (10.5% of all subjects). Thirty
(5.1%) subjects experienced severe TEAEs, and the proportion with severe events was larger in the saline group
(6.4%) than the EUFLEXXA group (3.8%). Overall, 10.4% of subjects had TEAEs considered related to study device,
with comparable proportions in each treatment group (9.9% and 10.8% for EUFLEXXA and saline, respectively).
During the extension phase, 43.4% (188/433) of subjects reported 377 TEAEs. Of these 43.8% (96/219) subjects
receiving repeated EUFLEXXAreported 199 TEAEs. The most frequently reported preferred term in subjects formerly
assigned to the core study EUFLEXXA group were arthralgia (8.7%), nasopharyngitis (4.6%), injury (4.1%), upper
respiratory tract infections (2.7%), joint swelling (2.7%), back pain (2.7%), and sinusitis (2.3%). Of these TEAEs 9
(4.1%) subjects had study device related AEs classified as “Certain,” “Probable,” “Possible” or “Un-assessable.” The
most common related TEAEs were arthralgia (2.3%) and joint swelling (1.4%). Table 4 shows the Study Device
Related Treatment-Emergent Adverse Events by Preferred Term with an Incidence of > 1 among Treatment Groups
(Safety Population).
Table 4: Study Device Related Treatment-Emergent Adverse Events by Preferred Term with an Incidence of
> 1 among Treatment Groups (Safety Population)
Extension
Study
Repeat
Injection
for
26 Week FLEXX Study (Core)
52 Weeks*
All Treatments
Saline
EUFLEXXA
EUFLEXXA
System Organ Class
N = 588
N = 295
N = 293
N = 219
Preferred Term
n (%)
n (%)
n (%)
n (%)
Any related TEAEs
61 (10.4)
32 (10.8)
29 (9.9)
9 (4.1)
Musculoskeletal and connective tissue disorders
Arthralgia
23 (3.9)
13 (4.4)
10 (3.4)
5 (2.3)
Joint swelling
3 (0.5)
2 (0.7)
1 (0.3)
3 (1.4)
Pain in extremity
3 (0.5)
3 (1)
0
0
Skin and subcutaneous tissue disorders
Erythema
5 (0.9)
3 (1)
2 (0.7)
0
*TEAEs are for subjects who received EUFLEXXA in both the core and extension (219 out of 433).
N = number of subjects in a given treatment group for the population analyzed; n = number of subjects reporting
at least 1 AE within system organ class/preferred term; (%) = percentage of subjects based on N; TEAE = treatmentemergent adverse event.
Note: Related AEs are AEs with study device relationship classified as “Certain,” “Probable,” “Possible” or
“Un-assessable.”
Twenty-three serious TEAEs were reported in 19 (3.2%) subjects during the study: 10 (3.4%) subjects in the
EUFLEXXA group and 9 (3.1%) subjects in the saline group. One of these events was considered related to the
study device (increased redness of the left knee joint in the EUFLEXXA group). Eight (1.4%) subjects had 9 TEAEs
leading to discontinuation: 3 (1.0%) subjects in the EUFLEXXA group and 5 (1.7%) subjects in the saline group.
Twelve (2.8%) subjects reported 20 serious TEAEs during the extension phase. Six of these subjects had received
EUFLEXXAduring the core study. None of the serious TEAEs was considered related to study device, and all resolved.
Two (0.5%) subjects had TEAEs leading to discontinuation from the study, one of whom received EUFLEXXA
during the core study; both subjects had events that were considered unrelated to study device.
Two subjects on saline experienced joint effusion. There were no reports of joint effusion among subjects
receiving EUFLEXXA during the core and extension phase.
Toll free number for providers and patients to call with questions:
1-(888)-FERRING (1-(888)-337-7464).
Or visit www.euflexxa.com.
MANUFACTURED FOR:
FERRING PHARMACEUTICALS INC.
PARSIPPANY, NJ 07054
MANUFACTURED BY:
Bio-Technology General (Israel) Ltd.
Be’er Tuvia, Kiryat Malachi 83104, Israel
6122-10 9/2011
EUFLEXXA® is a registered trademark of Ferring B.V.
1/13
EUF-08264
March Image Quiz: AIIS Avulsion Fracture
Figure 1
Figure 2
AP and lateral x-rays (Figures 1 and 2 above) show an anterior inferior iliac spine (AIIS) avulsion fracture.
An AIIS avulsion fracture represents an apophyseal injury at the insertion site of the rectus femoris. This
injury generally occurs with a sudden forceful extension of the hip causing a pull of the rectus femoris.
Patients often complain of feeling a “pop” during the injury and increased pain with hip flexion. Exam
findings may include localized pain and tenderness over the AIIS. Increased pain is elicited with resistive
hip flexion and knee extension. An AP pelvis x-ray should be obtained to confirm an avulsion fracture vs.
a normal adolescent variant. Treatment consists of partial weight bearing for 2-3 weeks on crutches then
weight bearing as tolerated thereafter. The patient is instructed to avoid active hip flexion and passive
hip extension for 2-3 weeks. Physical therapy is initiated at 3 weeks with a focus on a gradual increase in
strength training. Return to sports without restrictions can begin at 8 weeks if the patient is back to full
strength. Open reduction and internal fixation is rarely indicated with AIIS avulsion fractures; surgical
indications may include displacement > 2 cm, painful nonunion, and exostosis formation.
Readers Comments:
PM: “I usually have them on crutches and NWB for the 1st week then progress to WBAT. No kicking for at
least 2 weeks. Then some light jogging and progress to sprints and kicking after that. Only pearl is that
the point of maximum tenderness is over the insertion as well as pain in that area with resistive hip flexion
in a seated position. The only other comment I would make is that this is a common soccer injury. I have
seen several of these in high school soccer players and they do respond to conservative treatment. ”
CF: “I usually keep them NWB until pain free, gentle ROM and stretches, and return to sports after the
fracture is healed.”
One reader suggested a posterior wall avulsion fracture. In the opinion of one trauma surgeon: “the
fracture line doesn’t extend far enough distally to be considered a posterior wall fracture and the line may
just involve the postior lip. This results from the avulsion fracture extending a little further down and
pulling some of the lip off. Given the patient is 13-years old I would hesitate to get a CT scan for radiation
exposure, especially given the classic history of a kicking injury. Judet views (Internal/ External Oblique
views would be helpful in this case”.
22
JOPA
May Image Quiz: Erythema migrans
This is a case of a 14-year-old
boy who presented with a concerning
rash on his lower right abdomen (Figure
1). He did not recall any insect bites at
the time and believed the rash started 2
days prior to being examined. The boy
described the rash as nonpainful and
nonpruritic. He denied any symptoms
of fever or body aches, but did admit to
mild right-sided grown pain.
Figure 1
This classic “bull’s eye rash”
or erythema migrans is diagnostic
for Lyme disease. The patients groin
pain was likely related to inguinal
lymphadenopathy. He was treated
successfully with a 14-day course
of doxycycline 100 mg po bid. The
rash resolved after the first week of
treatment. No prolonged symptoms
were reported through 8 months after
treatment.
Lyme Disease
Lyme disease is caused by the bacterium Borrelia burdorferi and is spread by the bite of an infected
tick. Most infected humans are bitten by immature ticks called nymphs that can be less than 2 mm long.
These ticks are very difficult to see and many patients never recall being bitten. The presence of a “bull’s
eye rash” or erythema migrans is diagnostic of Lyme disease regardless of symptoms or questionable
history of a known tick bite. Erythema migrans occurs at approximately day 7 after a tick bite (range 3-30
days) in 70-80% of infected persons.
Early symptoms of Lyme disease may also include headache, fever, muscle aches, and swollen
glands. Treatment of early Lyme disease and erythema migrans includes doxycycline 100 mg po bid,
amoxicillin 500 mg po tid, or cefuroxime axetil 500 mg po bid for 14 days (range 10-21 days).
The infection may spread to the joints, the heart, and the nervous system if left untreated. Symptoms
may progress to neck stiffness, joint swelling, facial palsy, and heart palpitations. Approximately 60%
of untreated patients will have intermittent bouts of arthritis, with severe joint swelling and pain most
commonly occurring in the knees. Patients presenting with a joint effusion and suspicion of Lyme disease
should have Lyme titers drawn as well as a PCR from a joint fluid aspirate. Lyme arthritis is usually treated
successfully with a 28-day course of oral antibiotics including doxycycline, amoxicillin, and cefuroxime
axetil (see doses above). Arthroscopic synovectomy is rarely necessary but may be used in the presence
of antibiotic refractory Lyme arthritis.
Prevent tick bites and Lyme disease this summer! Use insect repellents with 20 to 30% DEET. Check
yourself and your family when returning from tick infested outdoor areas. Use treatments for pets so they
don’t bring ticks in your house. Several other helpful tips can be found on the CDC website along with
further information on Lyme disease. Visit http://www.cdc.gov/lyme/
JOPA 23
April Image Quiz: Slipped Capital Femoral Epiphysis
Figure 1
Figure 2
AP pelvis and frog leg lateral x-rays (Figures 1 & 2) show a subtle slipped capital femoral epiphysis.
Figure 3
Figure 4
The patient underwent urgent in-situ cannulated screw fixation. She was placed on crutches and
remained non-weight bearing for 4-6 weeks. Labs were ordered, including thyroid and renal function
tests, as well as a vitamin D level. She resumed weight bearing as tolerated and started physical therapy
at 6 weeks. Athletics were resumed when her strength returned at 10 weeks postoperatively.
24
JOPA
Slipped Capital Femoral Epiphysis
A Case Study
Marlon J. Alexander, MPAS, PA-C
UT Health Science Center Houston, TX
An 11-year old female presents to the children’s
emergency department with a 9-day history of right hip
pain. She reports the pain to be 5/10 on a numerical
scale and localized to the right hip without any
proximal or distal radiation. The pain is aggravated
with activity and relieved with pain medications and
rest. Her mechanism of injury was running during a
school party with a slip and fall onto the right hip. She
is uncertain of the extent of the fall. There was no loss
of consciousness. Initially she was transported to an
outside ED for evaluation. X-rays at the outside ED
were negative for a right hip fracture. The patient was
discharged on Tylenol #3 and informed to follow-up
with her pediatrician within a week.
The following week she presented to the
office with worsening right hip pain. She denied fever,
night sweats, headaches, abdominal pain, back pain,
numbness and tingling in the right lower extremity.
Her development is age appropriate. Her past medical
history was unremarkable. Past surgical history
included in situ screw fixation of left slipped capital
femoral epiphysis 8 months ago.
Figure 1
Physical Exam
The patients vital signs in clinic included a BP of
105/49, respiration rate of 20, heart rate of 74 beats per
minute, Temperature of 97.4°F with a 24 hr. Tmax 98.4°F,
and a SaO2 100% RA. The patient is well developed,
well-nourished young female appropriate for her age.
The patient guards her right hip and she is unable to
bear weight without assistance. Exam of the bilateral
upper extremities does not reveal gross asymmetry
on inspection. There is no pain with palpation and full
range of motion in all joints of the upper extremities
is noted. Exam of the left lower extremity reveals full
range of motion in all planes at left hip, left knee, left
foot and ankle. Dorsalis pedis, anterior tibial and
Figure 2
posterior tibial pulses are 2+ bilaterally. Pain is elicited
with logrolling of the right hip and with palpation near
the groin. Limited flexion of right hip is noted with active range of motion. Full range of motion is noted of
the right knee, right foot and ankle. There is no erythema, warmth, nor edema present. Muscle strength is
5/5 in the LLE and 3/5 RLE. A negative straight leg raise and negative FABER is noted bilaterally. Spinal exam
shows normal alignment, no asymmetry, and iliac crest heights are symmetrical. No pain is elicited with
palpation of spinal column and there is no paraspinal muscle tenderness.
Lab tests were ordered including a CBC with differential, a Chem 7, a thyroid panel, PTT, INR, and a
type and screen; results were pending at the time of this paper. An AP pelvis and hip x-rays of the right hip
were taken (Figures 1 and 2).
JOPA 25
Differential Diagnosis:
1. Legg-Perthes Disease
2. Slipped Capital Femoral Epiphysis (SCFE)
3. Toxic Synovitis
4. ASIS Avulsion Fracture
5. Neoplasm
Impression:
A right slipped capital femoral epiphysis
with valgus orientation is demonstrated. There
is an abnormal line of Klein. The femoral head
ossification center demonstrates normal contour
without sclerosis.
Surgical Intervention:
In situ cannulated screw fixation of right
slipped capital femoral epiphysis. Findings
included a valgus type slipped capital femoral
epiphysis, stable after fixation with 2 fully threaded
6.5 mm cannulated screws (Figures 3 & 4).
Discussion
Slipped capital femoral epiphysis (SCFE)
should always be considered when adolescent
patients present with hip pain and difficulty
bearing weight. Early detection and treatment is
essential to avoid long-term complications such
as avascular necrosis and early degenerative
joint disease. Exam and radiographic findings for
SCFE may be subtle so a thorough evaluation is
necessary.
SCFE typically occurs in adolescent males
aged 13 to 15 years old with a 2:1 male to female
ratio.1 This age group is associated with the period
of maximal skeletal growth (peak height velocity).2
Rapid growth during puberty results in a period
of decreased physeal strength. Physiological
loading on a weaken physis results in an increased
risk of developing SCFE.2 Obese patients are at an
increased risk secondary to addition physiological
loading on the physis. The hips may be affected
unilaterally or bilaterally. SCFE occurs bilaterally
over 25% of the time with both slips generally
occurring within the same 6 month period. The
most common presentations for SCFE include:
hip or groin pain, thigh pain, knee pain, limp, and
decreased range of motion of the affected hip,
often with no history of trauma. In patients who
present with SCFE, 60% of children are in the 95th
percentile for body mass. A high index of suspicion
must be maintained in patients with Down
Syndrome, a history of endocrine abnormalities, or
a slip under the age of 10 years.2. Endocrinopathies
26
JOPA
Figure 3
Figure 4
Figure 5. Kline’s Line. Used with permission from Houghton
Pediatric Rheumatology 2009 7:10 doi:10.1186/1546-0096-7-10
Figure 6. Frog leg lateral x-ray showing
a displaced slip. Submitted by
Charles D. Frost, DHSc, PA-C
account for 5-8% of all slips with the most common being hypothyroidsim, panhypopituitarism, growth
hormone abnormalities, and hypogonadism. An endocrine work-up should be done when SCFE occurs in
patients younger than 10 years of age and older than 15 years of age. Patients with renal osteodystrophy
have a higher rate of SCFE due to secondary hyperparathyroidism.
Classification
Clinical classification of SCFE is dependent on the duration of symptoms when the patient presents
to clinic. Acute slips are characterized by duration of symptoms for less than 3 weeks. Chronic slips are
classifed by symptoms for greater than 3 weeks. Acute-on-chronic slips have had symptoms for at least 3
weeks with a new shorter duration of increased pain. Most slips show slow progressive displacement, but
if left untreated, can cause significant disability. Another classification system is based on physeal stability
and the predictability of developing osteonecrosis. Patients are determined to have unstable SCFE if they
cannot bear weight on the affected extremity, with or without crutches, and stable SCFE if they can bear
weight. Osteonecrosis was found to develop in nearly 50% of patients with unstable SCFE and in no patients
classified as having stable SCFE.1
Describing displacement in a SCFE requires understanding that the head does not move, the Salter
I fracture of the physis allows the femoral neck to rotate from under the capital epiphysis. Understanding
the extra-osseous and intra-osseous blood supply to the proximal femur is critical to help minimize the
frequency of complications. The extra-osseous blood supply consists of the medial and lateral femoral
circumflex arteries which penetrate the hip capsule and supply the femoral head, neck and trochanter.
Epiphyseal branches of these vessels cross the physis into the epiphysis. When a SCFE occurs these
vessels may be violated which puts the affected hip at risk for osteonecrosis.1
Plain anteroposterior and frog leg lateral radiographs of both hips are the gold standard to
confirm the diagnosis of SCFE. SCFE is best seen on frog leg lateral radiograph. In most cases SCFE can be
diagnosed on plain films. A paralell line draw along the lateral femoral neck (Klein’s Line) should intersect
a small amount of the epiphysis. When Klein’s line doesn’t intersect some of the physis, SCFE should be
suspected. Radiographic appearance of SCFE may show the femoral epiphysis slipped slightly medially,
inferiorly, and posteriorly. Patients with chronic SCFE may have new bone formation on the inferior medial
femoral neck. A slip may not be seen on initial x-rays and an MRI can help diagnose SCFE in the pre-slip
period. MRI findings may include physeal widening and edema. Techntium-99 Bone scan and MRI can
be used to detect avascular necrosis (AVN) with MRI remaining highly specific for AVN.4 MRI can also be
helpful to rule out other conditions in the differential including tumors, infections, subtle fractures, or
JOPA 27
surrounding soft tissue injuries. Ultrasound is seldom used for diagnosing SCFE. Initial laboratory workup may include labs to rule out septic joint, chemistry panel to rule out renal failure, thyroid panel for
endocrine abnormalities, and lyme titers to rule out lyme disease.
Treatment
In situ cannulated hip screw fixation is the preferred treatment for SCFE. Previous treatment with hip
spica casting has largely been discontinued due its associated high complication rates and to the success
of in situ screw fixation. The goal of treatments is to prevent OA by maintaining femoral head/acetabulum
positioning, maintain blood supply of the femoral head preventing osteonecrosis, and eliminating pain
acutely. Patients with stable slips may begin to use a walker or crutches with partial weight bearing
restrictions for 6 weeks postoperatively. At 6 weeks the pain should resolve completely. Athletic activities
are resumed after 3 months. Physeal closure occurs 6-12 months after surgery. Screw removal is not
routinely performed or recommended.
A postoperative CT scan is useful in the assessment of persistant pain. CT can show whether
screw or pin fixation has penetrated the hip joint after fixation. It also confirms closure of the physis if
recurrent pain is an issue in a previously treated hip. The risk of developing AVN and early chondrolysis
is signifcantly greater in patients who presented with unstable SCFE preoperatively. For severe forms of
SCFE, treatment options may include primary femoral osteotomy, bone graft epiphysiodesis, femoral neck
osteoplasty, valgus derotational osteotomy and propylactic fixation of the contralateral hip.2
Conclusion:
Children between the ages of 10 and 16-years old who present to your clinic with a limp and pain
in the groin, hip, thigh, or knee should be considered to have a SCFE until proven otherwise. Remember,
pulled groin muscles are rarely correct in children, although this common misdiagnosis is still made.
Clinicians should be aware of the endocrine abnormalities associated with SCFE and the need to manage
comorbidities or seek consultation when appropriate.
References
1. Weber E, Naujoks R, Smith BG. Slipped Capital Femoral Epiphysis: Orthopedic Knowledge Online Journal
2008.
2. Kay, R.M. (2006). Slipped capital femoral epiphysis. In R.T. Morrissy & S.L. Weinstein (Eds.), Lovell and
Winter’s pediatric orthopaedics (pp. 1085-1116). Philadelphia, PA: Lippincott Williams & Wilkins
3. Aronsson DD, Loder RT, Breur GJ, Weinstein SL. Slipped Capital Femoral Ephiphysis: Current concepts.
JAAOS. 2006; 14: 666-679
4. Herring, J. A. (2008). Tachdjian’s pediatric orthopaedics. Retrieved from http://www.expertconsultbook.
com.
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