Rationale and Surgical Technique for PCL and Multiple Knee

Rationale and Surgical Technique for PCL and
Multiple Knee Ligament Reconstruction
Gregory C. Fanelli, M.D.
Featuring the Fanelli™ PCL/ACL System,
Bio-Core™ Interference Screw, Poly Suture Button,
Fanelli™ Magellan Suture Retriever and Graft Tensioning Boot
The Fanelli™ PCL/ACL Guide
facilitates accurate and
reproducible tunnel placement for
PCL and ACL Reconstructions.
Fanelli™ Magellan
Suture Retriever
Fanelli™ System
Instruments
Graft Tensioning
Boot
Double Bundle
Aimers
• Facilitates suture
retrieval during PCL and
ACL reconstruction
• Promotes reproducible
graft passage
• Facilitates PCL and
ACL reconstruction
techniques
• Self retaining tensioner
eliminates manual
tensioning
• Allows surgeon to use both hands for tibial fixation
• Tension grafts up to 20 lbs
• Size specific aimers
for double bundle
tunnel diameters
• Allows visualization
of tunnel placement
in double bundle PCL
and ACL procedures
to provide adequate
bone bridge
Rationale and Surgical Technique for PCL
and Multiple Knee Ligament Reconstruction
Overview
This manual contains the surgical technique
for the transtibial tunnel posterior cruciate
ligament (PCL) reconstruction, combined
anterior cruciate ligament (ACL) and
posterior cruciate ligament reconstruction
using the Arthrotek® Fanelli™ PCL/ACL
System, and several methods of medial and
lateral side reconstructions. The reference
section contains a list of text books, and
scientific articles on these subjects, and the
reader is referred to these resources for a
more in depth review of the subject material.
Patient Positioning
The patient is placed on the operating
room table in the supine position, and
after satisfactory induction of anesthesia,
the operative and nonoperative lower
extremities are carefully examined. A
tourniquet is applied to the upper thigh of
the operative extremity, and that extremity is
prepped and draped in a sterile fashion.
When allograft tissue is used, it is prepared
prior to bringing the patient into the
operating room. Autograft tissue is harvested prior to beginning the
arthroscopic portion of the procedure.
The arthroscopic instruments are inserted
with the inflow through the superolateral
patellar portal. Instrumentation and
visualization is achieved through
inferomedial and inferolateral patellar
portals, and can be interchanged as
necessary. Additional portals are established
as necessary. Exploration of the joint consists
of evaluation of the patellofemoral joint, the medial and lateral compartments, medial and lateral menisci, and the
intercondylar notch.
When there is a posterior cruciate ligament
tear, the tear of the PCL is identified and the
intact anterior cruciate ligament is confirmed.
The residual stump of the posterior cruciate
ligament is debrided with the synovial
shaver and hand tools as necessary. In the
case of a combined ACL/PCL injury, the
residual stumps of both the anterior and
posterior cruciate ligaments are debrided.
In patients with combined ACL/PCL injuries,
the notchplasty for the ACL portion of the
procedure is performed at this time.
This brochure is presented to demonstrate the surgical technique utilized
by Gregory Fanelli, M.D. Arthrotek, as the manufacturer of this device, does
not practice medicine and does not recommend this or any other surgical
technique for use on a specific patient. The surgeon who performs any
procedure is responsible for determining and utilizing the appropriate
techniques for such procedure for each individual patient. Arthrotek is not
responsible for selection of the appropriate surgical technique to be utilized
for an individual patient.
Rehabilitation activities vary depending on the individual patient and
physician’s recommendations.
Bio-Core™
Interference Screw
• Resorbable interference
screw made of
LactoSorb® L15
resorbable copolymer
• Ability to be filled with autograft or
allograft bone
Poly Suture Button
• Solid fixation for either
primary or auxiliary
fixation in ACL or PCL
reconstruction
• Distal fixation allows
circumferential healing
of the ACL and/or PCL
graft to the tunnel wall
The Fanelli™ PCL/ACL System was developed in conjunction with Gregory C.
Fanelli, M.D., Danville, Pennsylvania.
Bio-Core™ and Fanelli™ are trademarks of Arthrotek, Inc.
LactoSorb® is a trademark of Biomet Manufacturing Corp.
Surgical Technique
Figure 1
Figure 2
Initial Incision
Elevating the Capsule
An extra capsular extraarticular posteromedial safety
incision is made by creating an incision approximately
1.5 to 2cm long starting at the posteromedial border of
the tibia approximately one inch below the level of the
joint line and extending distally (Figure 1). Dissection
is carried down to the crural fascia, which is incised
longitudinally. Care is taken to protect the neurovascular
structures. An interval is developed between the medial
head of the gastrocnemius muscle posterior, and the
capsule of the knee joint anterior. The surgeon’s gloved
finger is able to position the neurovascular structures
posterior to the finger and the capsule anterior to
the finger (Figure 2). This is so that the surgeon can
monitor tools such as the over-the-top PCL tools, and
the Fanelli™ PCL/ACL drill guide as it is positioned in
the posterior aspect of the knee. This also allows for
accurate placement of the guide wire both in a medial
lateral, and a proximal distal direction. The PCL and
ACL reconstructions are performed with the knee in
approximately 70˚– 90˚of knee flexion.
The curved over-the-top PCL instruments are used to
sequentially lyse adhesions in the posterior aspect of
the knee, and elevate the capsule from the tibial ridge
posterior. This will allow accurate placement of the
Fanelli™ PCL/ACL guide, and correct placement of the
tibial tunnel (Figure 3).
Figure 3
Figure 5
Figure 4
Positioning of the Guide
The arm of the Fanelli™ PCL/ACL guide is inserted
through the inferior medial patellar portal. The tip of the
guide is positioned at the inferior lateral aspect of the
PCL anatomic insertion site. This is below the tibial ridge
posterior and in the lateral aspect of the PCL anatomic
insertion site. The bullet portion of the guide contacts
the anteromedial surface of the proximal tibia at a point
midway between the posteromedial border of the tibia,
and the tibial crest anterior approximately 1cm below
the tibial tubercle (Figure 4). This will provide an angle of
graft orientation such that the graft will turn two very
smooth 45˚ angles on the posterior aspect of the tibia
and will not have an acute 90˚ angle turn which may
cause pressure necrosis of the graft (Figure 5). The tip of the guide, in the posterior aspect of the tibia, is
confirmed with the surgeon’s finger through the
extracapsular extraarticular posteromedial safety
incision. Intraoperative AP and lateral X-ray may also be
used. The Fanelli™ PCL/ACL guide may be adjusted so
that the guide wire shoots to the tip or the elbow of the
guide as the surgeon prefers. When the Fanelli™ PCL/ACL
guide is positioned in the desired area, a blunt spadetipped guide wire (909634) is drilled from anterior to
posterior. The arthroscope, in the posterior medial portal,
visualizes the tip of the guide wire. The surgeon’s finger
confirms the position of the guide wire through the
posterior medial safety incision. This is a double safety check.
Surgical Technique
Figure 6
Figure 7
Drilling the Tibial Tunnel
The appropriately sized standard cannulated reamer is
used to create the tibial tunnel. The curved PCL closed
curette is positioned to cup the tip of the guide wire. The arthroscope, positioned in the posterior medial
portal, visualizes the guide wire being cupped, which
protects the neurovascular structures (Figure 6). The
surgeon’s finger through the extra capsular extraarticular
posteromedial incision is monitoring the position of
the guide wire. When the drill is engaged in bone, the
guide wire is reversed, blunt end pointing posterior, for
additional patient safety.
The drill is advanced until it comes to the posterior cortex
of the tibia. The chuck is disengaged from the drill, and
completion of the tibial tunnel is performed by hand
(Figure 7). This gives an additional margin of safety for
completion of the tibial tunnel. The tunnel edges are then
chamfered and rasped with the Fanelli™ PCL/ACL system
rasp (Figure 8).
Figure 8
Figure 10
Figure 9
Drilling the Femoral Tunnel Outside In:
Single and Double Bundle PCL Reconstruction
The Fanelli™ PCL/ACL guide is positioned to create the
femoral tunnel. The arm of the guide is introduced
through the inferomedial patellar portal and is
positioned such that the guide wire will exit through the
center of the stump of the anterior lateral bundle of the
posterior cruciate ligament (Figure 9).
The blunt spade-tipped guide wire (909634) is drilled
through the guide, and just as it begins to emerge
through the center of the stump of the PCL anterior
lateral bundle, the drill guide is disengaged. The
accuracy of the placement of the wire is confirmed
arthroscopically with probing and visualization. Care
must be taken to ensure the patellofemoral joint has
not been violated by arthroscopically examining the
patellofemoral joint prior to drilling.
The appropriately sized standard cannulated reamer is
used to create the femoral tunnel. A curette is used to
cap the tip of the guide wire so there is no inadvertent
advancement of the guide wire, which may damage
the anterior cruciate ligament or articular surface. As
the reamer is about to penetrate interiorly, the reamer
is disengaged from the drill and the final reaming is
completed by hand (Figure 10). This adds an additional
margin of safety. The reaming debris is evacuated with
a synovial shaver to minimize fat pad inflammatory
response with subsequent risk of arthrofibrosis. The
tunnel edges are chamfered and rasped.
Surgical Technique
Figure 12
Figure 11
Drilling the Femoral Tunnel Outside In:
Single and Double Bundle PCL Reconstruction (continued)
When the double bundle PCL reconstruction is
performed, the Fanelli™ PCL/ACL guide is positioned
to create the second femoral tunnel. The arm of the
guide is introduced through the inferior medial patellar
portal, and is positioned such that the guide wire will
exit through the center of the stump of the posterior
medial bundle of the posterior cruciate ligament
(Figure 11). The blunt spade-tipped guide wire (909634)
is drilled through the guide, and just as it begins to
emerge through the center of the stump of the PCL
posterior medial bundle, the drill guide is disengaged.
The accuracy of the placement of the wire is confirmed
arthroscopically with probing and visualization. Care
must be taken to ensure that there will be an adequate
bone bridge (approximately 5mm) between the two
femoral tunnels prior to drilling. This is accomplished
using the calibrated probe, and direct arthroscopic
visualization.
The appropriately sized standard cannulated reamer
is used to create the posterior medial bundle femoral
tunnel. A curette is used to cap the tip of the guide wire
so there is no inadvertent advancement of the guide
wire, which may damage the anterior cruciate ligament,
or articular surface. As the reamer is about to penetrate
interiorly, the reamer is disengaged from the drill and
the final reaming is completed by hand (Figure 12).
This adds an additional margin of safety. The reaming
debris is evacuated with a synovial shaver to minimize
fat pad inflammatory response with subsequent risk
of arthrofibrosis. The tunnel edges are chamfered and
rasped.
Figure 15
Figure 13
Figure 14
Figure 16
Drilling the Femoral Tunnel Inside Out:
Single and Double Bundle PCL Reconstruction
The PCL single bundle or double bundle femoral
tunnels can be made from inside out using the Fanelli™
Double Bundle Aimers. The appropriately sized double
bundle aimer is inserted through a low anterior lateral
patellar arthroscopic portal. The double bundle aimer
is positioned directly on the footprint of the femoral
anterior lateral bundle PCL insertion site (Figure 13). The
appropriately sized guide wire is drilled through the
aimer, through the bone, and out a small skin incision.
Care is taken to insure there is no compromise of the
articular surface.
The double bundle aimer is removed, and an acorn
reamer is used to endoscopically drill from inside out the
anterior lateral bundle PCL femoral tunnel (Figure 14).
The tunnel edges are chamfered and rasped. The
reaming debris is evacuated with a synovial shaver to
minimize fat pad inflammatory response with
subsequent risk of arthrofibrosis. When the surgeon
chooses to perform a double bundle double femoral
tunnel PCL reconstruction, the same process is repeated
for the posterior medial bundle of the PCL (Figures 15
and 16). Care must be taken to ensure that there will be
an adequate bone bridge (approximately 5mm)
between the two femoral tunnels prior to drilling. This is
accomplished using the calibrated probe, and direct
arthroscopic visualization.
Surgical Technique
Figure 17
Figure 20
Figure 18
Tunnel Preparation, Graft Passage,
and PCL Femoral Fixation
PCL Graft Tensioning and
Tibial Fixation
A Fanelli™ Magellan suture retriever (909808) is
introduced through the tibial tunnel into the joint
(Figure 17), and may be retrieved through the femoral
tunnel (Figure 18). The traction sutures of the graft
material are attached to the loop of the Magellan
suture retriever, and the graft is pulled into position.
The graft material is secured on the femoral side using
the Arthrotek® Bio-Core™ Interference Screw for primary
aperture opening fixation, and an Arthrotek® Poly Suture
Button for back up fixation.
Tension is placed on the PCL graft
distally using the Arthrotek® Graft
Tensioning Boot, and the tension
is set to restore the anatomic
tibial step off. The knee is cycled
through a full range of motion
25 times to allow pre-tensioning
and settling of the graft. In double
bundle PCL reconstructions, each
bundle is individually tensioned.
The process is repeated until
there is no further change in
the torque setting on the graft
tensioner and the anatomic tibial Figure 19
step off is restored. The knee is
placed in 70˚ of flexion, and fixation is achieved on the
tibial side of the PCL graft with an Arthrotek® Bio-Core™
Interference Screw, and back up fixation with a bicortical
screw and spiked ligament washer (Figure 20).
Figure 21
ACL Reconstruction
With the knee in approximately 70˚– 90˚ of flexion, the
ACL tunnels are created using the Fanelli™ PCL/ACL
guide. The arm of the Fanelli™ PCL/ACL guide enters the
knee joint through the inferior medial patellar portal (Figure 21). The bullet of the drill guide contacts the
anterior medial proximal tibia externally at a point
approximately 1 cm proximal to the tibial tubercle
midway between the posterior medial border of the
tibia, and the tibial crest anteriorly. The guide wire is
drilled through the guide to emerge through the center
of the stump of the ACL tibial footprint. A standard
cannulated reamer is used to create the tibial tunnel
(Figure 22). Reaming debris is evacuated, and the tunnel
edges are chamfered and rasped.
Figure 22
Surgical Technique
Figure 23
Figure 24
ACL Reconstruction (continued)
With the knee in approximately 90˚ of flexion, an over
the top Femoral Aimer is introduced through the tibial
tunnel, and used to position a guide wire on the medial
wall of the lateral femoral condyle (Figure 23). The
femoral tunnel is created to approximate the ACL
anatomic insertion site, and the off set of the size specific
Femoral Aimer will leave a 1–2mm posterior cortical wall so interference fixation can be used (Figure 24). The ACL graft is positioned, and fixation achieved on the
femoral side using an Arthrotek® Bio-Core™ Interference
Screw, and back up fixation with an Arthrotek® Poly
Suture Button.
The ACL graft is tensioned on the tibial side using the
Arthrotek® Graft Tensioning Boot (Figure 25). Traction is
placed on the ACL graft sutures, and tension is set. The
knee is then cycled through 25 full flexion and extension
cycles to allow settling of the graft. The process is
repeated until there is no further change in the torque
setting on the graft tensioner. The knee is placed in 70˚ of flexion, and fixation is achieved on the tibial side of the ACL graft with an Arthrotek® Bio-Core™ Interference Screw, and back up fixation with
an Arthrotek® Poly Suture Button. The final ACL and PCL
tunnel positions are demonstrated in Figures 26 and 27.
Figure 26
Figure 25
Figure 27
Surgical Technique
Figure 28
Figure 29
Lateral Posterolateral Reconstruction
One surgical technique for posterolateral reconstruction
is the free graft figure of eight technique utilizing
semitendinosus autograft or allograft, Achilles tendon
allograft, or other soft tissue allograft material (Figure 28). This procedure requires an intact proximal
tibiofibular joint. This technique combined with capsular
repair and/or posterolateral capsular shift procedures,
mimics the function of the popliteofibular ligament and
lateral collateral ligament, tightens the posterolateral
capsule, and provides a post of strong allograft tissue
to reinforce the posterolateral corner. When there is a
disrupted proximal tibiofibular joint, or hyperextension
external rotation recurvatum deformity, a twotailed (fibular head, proximal tibia) posterior lateral
reconstruction may be required (Figure 29).
Posterolateral reconstruction with the free graft figure
of eight technique utilizes semitendinosus autograft or
allograft, Achilles tendon allograft, or other soft tissue
allograft material (Figure 28). A curvilinear incision is
made in the lateral aspect of the knee extending from
the lateral femoral epicondyle to the interval between
Gerdy’s tubercle and the fibular head. The peroneal
nerve is dissected free, and protected throughout the
procedure. The fibular head is exposed and a tunnel
is created in an anterior to posterior direction at the
area of maximal fibular diameter. The tunnel is created
by passing a guide pin followed by a cannulated drill
usually 7mm in diameter. The free tendon graft is passed
through the fibular head drill hole. An incision is then
made in the iliotibial band in line with the fibers directly
overlying the lateral femoral epicondyle.
The graft material is passed medial to the iliotibial
band, and the limbs of the graft are crossed to form
a figure of eight. A drill hole is made approximately
1cm anterior to the fibular collateral ligament and
popliteus tendon femoral insertion. A longitudinal
incision is made in the lateral capsule just posterior
to the fibular collateral ligament. The graft material is
passed medial to the iliotibial band and secured to the
lateral femoral epicondylar region with a screw and
spiked ligament washer at the above mentioned point.
The posterolateral capsule that had been previously
incised is then shifted and sewn into the strut of figure
of eight graft tissue material to eliminate posterolateral
capsular redundancy. The anterior and posterior limbs of
the figure of eight graft material are sewn to each other
to reinforce and tighten the construct. The final graft
tensioning position is approximately 30˚– 40˚ of knee
flexion. The iliotibial band incision is closed.
Surgical Technique
Figure 30
Figure 31
Medial Posteromedial Reconstruction
Posteromedial and medial reconstructions are
performed through a medial incision. Care is taken to
maintain adequate skin bridges between incisions, and
to protect the neurovascular structures. The superficial
medial collateral ligament is exposed, and a longitudinal
incision is made just posterior to the posterior border of
the superficial MCL (Figure 30).
Care is taken to protect the medial meniscus during the capsular incision. The interval between the
posteromedial capsule and medial meniscus is
developed. The posteromedial capsule is shifted
anterosuperiorly. The medial meniscus is repaired to the
new capsular position, and the shifted capsule is sewn
into the medial collateral ligament.
When superficial MCL reconstruction is indicated, this is
performed using allograft or autograft tissue (Figure 31).
This graft material is attached at the anatomic insertion
sites of the superficial medial collateral ligament on
the femur and tibia using a screw and spiked ligament
washer, or suture anchors. The posteromedial capsular
advancement is performed, and sewn into the newly
reconstructed MCL. The final graft tensioning position is
approximately 30˚– 40˚ of knee flexion.
Overview of Graft Tensioning
and Fixation
The PCL is reconstructed first followed by the ACL
followed by the posterolateral complex, and medial
ligament complex. Tension is placed on the PCL graft
distally using the Arthrotek® Graft Tensioning Boot.
This restores the anatomic tibial step off. The knee is
cycled through a full range of motion 25 times to allow
pretensioning and settling of the graft. The knee is
placed in 70˚ of flexion, and fixation is achieved on the
tibial side of the PCL graft with an Arthrotek® Bio-Core™
Interference Screw, and screw and spiked ligament
washer. The Arthrotek® Graft Tensioning Boot is applied
to the ACL graft.
The knee is placed in 70˚ of flexion, and final fixation is
achieved of the ACL graft with a Arthrotek® Bio-Core™
Interference Screw, and Arthrotek® Poly Suture Button
back-up fixation on the femoral and tibial sides.
Tensioning the ACL graft at 70˚ of knee flexion enabled
us to maintain the neutral position of the knee by
monitoring the tibial step off at the time of final graft
fixation. The knee is placed in 30˚ of flexion, slight valgus
force applied to the knee, and final tensioning and
fixation of the posterolateral corner is achieved. The MCL
reconstruction is tensioned with the knee in 30˚ of
flexion. Full range of motion is confirmed on the
operating table to assure the knee is not “captured” by
the reconstruction.
Additional Technical Ideas
The posteromedial safety incision protects the
neurovascular structures and confirms accurate tibial
tunnel placement. It is important to be aware of the two
tibial tunnel directions, and to have an adequate bone
bridge between the PCL and ACL tibial tunnels. This will
reduce the possibility of fracture. We have found it useful
to use primary and back-up fixation. Primary fixation
is with Arthrotek® Bio-Core™ Interference Screws, and
back-up fixation is performed with a screw and spiked
ligament washer, an Arthrotek® Poly Suture Button.
Secure fixation is critical to the success of this surgical
procedure. Restoration of the normal tibial step-off
at 70˚ of flexion has provided the most reproducible
method of establishing the neutral point of the tibiafemoral relationship in our experience. Full range of
motion is confirmed on the operating table to assure the
knee is not “captured” by the reconstruction.
The Fanelli Sports Injury Clinic results for our PCL and
multiple ligament knee reconstructions are detailed
in the references listed in this technique manual. The
reader is referred to these resources.
References
PCL and Multiple Knee Ligament Injury Text Books by Gregory C. Fanelli, M.D.
Posterior Cruciate Ligament Injuries: A Practical Guide To Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag, New York, 2001.
The Multiple Ligament Injured Knee. A Practical Guide to Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag, New York, 2004.
PCL and Multiple Knee Ligament Injury Related Peer Reviewed Articles by Gregory C. Fanelli, M.D.
Gregory C. Fanelli, M.D., “Posterior Cruciate Ligament Injuries In Trauma Patients.” Arthroscopy 9(3) pp. 291–294, 1993.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig Edson, P.T.: “ Current Concepts Review. The Posterior Cruciate Ligament: Arthroscopic Evaluation And Treatment.” Arthroscopy Vol. 10, No. 6. pp. 673–688, December, 1994.
Gregory C. Fanelli, M.D., Craig J. Edson, P.T./A.T.C.: “Posterior Cruciate Ligament Injuries In Trauma Patients: Part II.” Arthroscopy Vol.
11, No. 5. pp. 526–529, 1995.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Arthroscopically Assisted Combined ACL/PCL
Reconstruction. Arthroscopy, Vol. 12, No.1., pp. 5–14, 1996.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: “Arthroscopically Assisted PCL/Posterior Lateral
Complex Reconstruction.” Arthroscopy, Vol. 12, No. 5, 1996.
Raymond M. Bleday, M.D., Gregory C. Fanelli, M.D., Bradley F. Giannotti, M.D., Craig J. Edson, M.H.S., P.T., A.T.C., Thomas A Barrett,
M.D.: “Instrumented Measurement of the Posterolateral Corner.” Arthroscopy, Vol. 14, No. 5: 489–494, 1998.
Gregory C. Fanelli, M.D., Daniel D. Feldmann, M.D., “The Dislocated/Multiple Ligament Injured Knee.” Operative Techniques In
Orthopaedics, 9(4):1–12, 1999.
Gregory C. Fanelli, M.D., Daniel D Feldmann, M.D., “Management of Combined Anterior Cruciate Ligament/Posterior Cruciate
Ligament/Posterolateral Complex Injuries of the Knee.” Operative Techniques In Sports Medicine, 7(3):143–149, 1999.
Gregory C. Fanelli, M.D.: “Combined Anterior and Posterior Cruciate Ligament Injuries: The Multiple Ligament Injured Knee.”
Sports Medicine And Arthroscopy Review, 7(4):289–295, 1999.
Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: “Complications of Posterior Cruciate Ligament Reconstruction. Sports Medicine
And Arthroscopy Review, 7(4):296–302, 1999. Gregory C. Fanelli, M.D.: “Treatment of Combined Anterior Cruciate Ligament-Posterior Cruciate Ligament-Lateral Side Injuries of
the Knee.” Clinics In Sports Medicine,19(3):493–502, 2000.
Gregory C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C., David R. Maish, M.D.: “Management of Combined ACL/PCL injuries.
Techniques In Orthopaedics,16(2):157–166, 2001.
Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: “Complications in posterior cruciate ligament and posterolateral complex
surgery.” Operative Techniques In Sports Medicine. April, 9(2);96–99, 2001. Gregory C. Fanelli, M.D.: “Surgical Treatment of the Acute and Chronic ACL/PCL/Medial Side/Lateral Side Injuries of the Knee.”
Sports Medicine and Arthroscopy Review, September, 9(3), 2001.
Gregory C. Fanelli, M.D., Roger V. Larson, M.D.: “Practical Management of Posterolateral Instability of the Knee.” Arthroscopy, 18(2)
{February, Suppl 1}:1–8, 2002.
Gregory C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C.: “Arthroscopically Assisted Combined ACL/PCL Reconstruction. 2–10 year
Follow-up.” Arthroscopy,18(7):703-714, 2002.
Gregory C. Fanelli, M.D.: “Arthroscopic Posterior Cruciate Ligament Reconstruction: Transtibial Tunnel Technique. Surgical
Technique and 2–10 Year Results.” Arthroscopy, 18(9):44–49, (December Supplement 2), 2002.
Gregory C. Fanelli, M.D.: “Surgical Treatment of ACL-PCL-Medial Side-Lateral Side Injuries of the Knee.” Operative Techniques in
Sports Medicine, 11(4):263–274, 2003.
Gregory C. Fanelli, M.D.: “Systematic Approach to the Multiple Ligament Injured Knee.” Arthroscopy; 19(30–37): (December
Supplement 1), 2003.
Gregory C. Fanelli, M.D., Craig J Edson, M.S., P.T./A.T.C.: “Combined Posterior Cruciate Ligament –Posterolateral Reconstruction
with Achilles Tendon Allograft and Biceps Femoris Tendon Tenodesis: 2–10 year Follow-up.” Arthroscopy, 20 (4): 339–345, 2004.
Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D.: “Complications in Posterior Cruciate Ligament Reconstruction.” Sports Medicine and
Arthroscopy Review, 12 (3): 196–201, 2004.
Bergfeld JA, Cooper DE, Fanelli GC, Harner CD: “Round Table Discussion. Reconstructing the PCL: Tips and Techniques.”
Orthopaedics Today, 24 (12): 1,16–21, 2004.
Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D., Craig J. Edson, M.S., P.T., A.T.C.: “Current Concepts: The Multiple Ligament Injured
Knee.” Arthroscopy, 21 (4): 471–486, 2005.
Gregory C. Fanelli, M.D.: “Surgical Reconstruction for Acute Posterolateral Injury of the Knee.” Journal of Knee Surgery, 18 (2):157–
162, 2005.
Fanelli GC, Edson CJ, Orcutt DR, Harris JD, Zijerdi D.: “Treatment of Combined ACL-PCL-MCL-PLC Injuries of the Knee.” Journal of
Knee Surgery, 18 (3):240–248, 2005.
Gregory C. Fanelli, M.D.: “Surgical Treatment of Lateral Posterolateral Instability of the Knee Using Biceps Femoris Tendon
Procedures.” Sports Medicine and Arthroscopy Review, February, 14(1), 2006.
Fanelli GC, Harris JD: “Surgical Treatment of Acute Medial Collateral Ligament and Posteromedial Corner Injuries of the Knee.
Sports Medicine and Arthroscopy Review, May, 14(2), 2006.
Fanelli GC, Harris JD. : “Late MCL (Medial Collateral Ligament) Reconstruction.” Techniques In Knee Surgery, (In Press), 2006.
Package Inserts
Arthrotek, Inc.
A Wholly Owned Subsidiary of Biomet, Inc. 56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581 USA
01-50-1058
Date: 07/04
RESORBABLE INTERFERENCE SCREW
ATTENTION OPERATING SURGEON
DESCRIPTION
Arthrotek® Resorbable Interference Screw is a resorbable interference fixation screw. The
device is made of LactoSorb®, a resorbable copolymer, which is a polyester derivative of lactic
acid and glycolic acid. Polylactic/ polyglycolic acid copolymer degrades and resorbs in vivo by
hydrolysis to lactic and glycolic acids that are then metabolized by the body.
INDICATIONS
Indications for use: Indications for the Resorbable Interference Screw include use in soft tissue
reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific
indications include the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator
cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis,
deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral
ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/
reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction,
biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral
collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule
closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair,
and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, 7.0mm, 8.0mm, 9.0mm, 10.0mm, 11.0mm, and 12.0mm
screws are indicated for the following uses:
1. To provide interference fixation of patellar bone-tendon–bone grafts in anterior cruciate ligament (ACL) reconstruction.
2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
CONTRAINDICATIONS
1. Active infection.
2. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
3. Patient conditions including: blood supply limitations, insufficient quantity or quality of bone for attachment or latent infections.
4. Pathologic soft tissue conditions, which would prevent secure fixations.
WARNINGS
Arthrotek internal fixation devices provide the surgeon with a means to aid in the management
of soft tissue to bone reattachment procedures. While these devices are generally successful
in attaining these goals, they cannot be expected to replace normal healthy soft tissue
or withstand the stress placed upon the device by full or partial weight bearing or load
bearing, particularly in the presence of incomplete healing. Therefore, it is important that
immobilization (use of external support, sling, etc.) of the treatment site be maintained
until healing has occurred. Surgical implants are subject to repeated stresses in use, which
can result in fracture or damage to the implant. Factors such as the patient’s activity level
and adherence to weight bearing or load bearing instructions have an affect on the service
life of the implant. The surgeon must be thoroughly knowledgeable not only in the medical
and surgical aspects of the implant, but also must be aware of the mechanical and polymeric
aspects of the surgical implants.
1. Correct selection of the implant is extremely important. The potential for success in soft tissue to bone fixation is increased by the selection of the proper type of implant. While proper selection can help minimize risks, the device is not designed to withstand the unsupported stress of full weight bearing, load bearing or excessive activity.
2. The implants can loosen or be damaged when subjected to increased loading associated with inadequate healing. If healing is delayed, or does not occur, the implant or the procedure may fail. Loads produced by weight bearing and activity levels may dictate the longevity of the implant.
3. Inadequate fixation at the time of surgery can increase the risk of loosening and migration of the device or tissue supported by the device. Sufficient bone quantity and quality are important to adequate fixation and success of the procedure. Bone quality must be assessed at the time of surgery. Adequate fixation in diseased bone may be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at greater risk of device loosening and procedure failure.
4.
5.
6.
7.
8.
9.
10.
11.
Care is to be taken to assure adequate soft tissue fixation at the time of surgery. Failure to achieve adequate fixation through improper positioning or placement of the device can contribute to a subsequent undesirable result.
The use of appropriate immobilization and postoperative management is indicated as part of the treatment until healing has occurred.
Correct handling of implants is extremely important. Do not modify implants. Do not notch or bend implants. Notches or scratches put in the implant during the course of surgery may contribute to breakage. Intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws.
Do not heat LactoSorb® Interference Screws by any means prior to implantation.
DO NOT USE if there is loss of sterility of the device. Discard and DO NOT USE opened or damaged devices, and use only devices that are packaged in unopened and undamaged containers.
DO NOT USE where a permanent implant is indicated.
DO NOT USE with other resorbable implant materials.
Adequately instruct the patient. Postoperative care is important. The patient’s ability
and willingness to follow instructions is one of the most important aspects of
successful soft tissue management. Patients affected with senility, mental illness,
alcoholism, and drug abuse may be at a higher risk of device or procedure failure. These
patients may ignore instructions and activity restrictions. The patient is to be instructed
in the use of external supports that are intended to immobilize the repair site and limit
weight bearing or load bearing. The patient is to be made fully aware and warned that
the device does not replace normal healthy tissue, and that the device can break, bend
or be damaged as a result of stress, activity, load bearing, or weight bearing. The patient
is to be made aware and warned of general surgical risks, possible adverse effects, and
to follow the instructions of the treating physician. The patient is to be advised of the
need for regular postoperative follow-up examination as long as the device remains
implanted.
PRECAUTIONS
Instruments are available to aid in the accurate implantation of internal fixation devices.
Intraoperative fracture or breaking of instruments has been reported. Surgical instruments
are subject to wear with normal usage. Instruments, which have experienced extensive use
or excessive force, are susceptible to fracture. Surgical instruments should only be used for
their intended purpose. Arthrotek recommends that all instruments be regularly inspected
for wear and disfigurement.
POSSIBLE ADVERSE EFFECTS
1. Infection can lead to failure of the procedure.
2. Neurovascular injuries can occur due to surgical trauma.
3. Bending, fracture, loosening, rubbing, and migration of the implant may occur as a result of excessive activity, trauma, or load bearing.
4. Implantation of foreign materials can result in an inflammatory response or allergic reaction.
5. Inadequate healing which may lead to breakage of the implant or failure of the graft material.
6. Pain, discomfort, or abnormal sensation due to the presence of the device.
7. Necrosis of the bone or tissue.
STERILITY
Arthrotek resorbable implants are sterilized by exposure to Ethylene Oxide (ETO) Gas. Do not
resterilize. Do not use past expiration date.
STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURES
GREATER THAN 120°F OR 49°C.
Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order
of a physician.
Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc.,
P.O. Box 587, Warsaw, IN 46581 USA, Fax: 574-372-1683.
Manufacturer:
Biomet Manufacturing Corp. Airport Industrial Park
P.O. Box 587 Warsaw, IN 46581-0587
Authorized Representative:
Biomet U.K., Ltd
Waterton Industrial Estates
Bridgend, South Wales
CF31 3XA, U.K.
СЄ0086
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that
date. To obtain a current package insert, please use the contact information provided herein.
Arthrotek, Inc. 01-50-1018
A Wholly Owned Subsidiary of Biomet, Inc. Date: 09/05
P.O. Box 587 56 East Bell Drive
Warsaw, Indiana 46581 USA
Arthrotek® Internal Fixation Devices
Attention Operating Surgeon
DESCRIPTION
Arthrotek manufactures a variety of internal fixation devices intended to aid in arthroscopic
and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or
degenerative disease. Implants used for this application include: screws, washers, anchors, pins,
and suture. Specialty implants are available for specialized treatments.
Materials:
316 LVM Stainless Steel
Titanium Alloy
Ultra-High Molecular Weight Polyethylene (UHMWPE)
Polyester
INDICATIONS
The Metal Screw Anchor and the Harpoon® Suture Anchor are indicated for use in soft tissue
reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications as follows:
Shoulder Indications – Bankart repair, SLAP lesion repair, acromio-clavicular separation,
rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid
repair.
Wrist/Hand Indications – Scapholunate ligament reconstruction, ulnar/radial collateral
ligament reconstruction.
Ankle/Foot Indications – Lateral stabilization, medial stabilization, Achilles tendon repair/
reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon
reconstruction.
Knee Indications – Medial collateral ligament repair, lateral collateral ligament repair,
posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and
patellar ligament/tendon repair.
Bone Mulch® Screws are intended for use in fixation of semitendinous and/or gracile tendon
grafts in ACL reconstruction, only.
Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendonbone grafts in ACL reconstruction.
Screw and Washers are indicated for soft tissue fixation to bone, and bone to bone fixation in
orthopedic procedures specifically during Ligament reconstruction. Toggle anchors (ie. toggle buttons and EZLoc™) are indicated for use for fixation of tendons
and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate
Ligament (ACL) Reconstruction.
Patient selection factors to be considered include: 1) need for soft tissue to bone fixation, 2)
ability and willingness of the patient to follow postoperative care instructions until healing is
complete, and 3) a good nutritional state of the patient.
CONTRAINDICATIONS
1. Infection.
2. Patient conditions including blood supply limitations, and insufficient quantity or
quality of bone or soft tissue.
3. Patients with mental or neurologic conditions who are unwilling or incapable of
following postoperative care instructions.
4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be
completed prior to implantation of the device.
WARNINGS
Arthrotek® internal fixation devices provide the surgeon with a means to aid in the
management of soft tissue to bone reattachment procedures. While these devices are generally
successful in attaining these goals, they cannot be expected to replace normal healthy bone or
withstand the stress placed upon the device by full or partial weight bearing or load bearing,
particularly in the presence of nonunion, delayed union, or incomplete healing. Therefore,
it is important that immobilization (use of external support, walking aids, braces, etc.) of
the treatment site be maintained until healing has occurred. Surgical implants are subject
to repeated stresses in use, which can result in fracture or damage to the implant. Factors
such as the patient’s weight, activity level, and adherence to weight bearing or load bearing
instructions have an effect on the service life of the implant. The surgeon must be thoroughly
knowledgeable not only in the medical and surgical aspects of the implant, but also must be
aware of the mechanical and metallurgical aspects of the surgical implants. 3. Inadequate fixation at the time of surgery can increase the risk of loosening and
migration of the device or tissue supported by the device. Sufficient bone quantity and
quality are important to adequate fixation and success of the procedure. Bone quality
must be assessed at the time of surgery. Adequate fixation in diseased bone may
be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at
greater risk of device loosening and procedure failure. 4. Implant materials are subject to corrosion. Implanting metals and alloys subjects them
to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each other can accelerate the
corrosion process that may enhance fracture of implants. Every effort should be made
to use compatible metals and alloys when marrying them to a common goal, i.e., screws
and plates.
5. Correct handling of implants is extremely important. Do not modify implants. Do not
notch or bend implants. Notches or scratches put in the implant during the course
of surgery may contribute to breakage. Intraoperative fracture of screws can occur if
excessive force (torque) is applied while seating bone screws.
6. Do not use excessive force when inserting suture anchors. Excessive force (long hard
hammer blows) may cause fracture or bending of the device. When encountering hard
cortical bone, predrill with a 3/32 or 1/8 inch drill prior to inserting suture anchors.
7. Adequately instruct the patient. Postoperative care is important. The patient’s ability
and willingness to follow instructions is one of the most important aspects of successful
fracture management. Patients effected with senility, mental illness, alcoholism, and
drug abuse may be at a higher risk of device or procedure failure. These patients may
ignore instructions and activity restrictions. The patient is to be instructed in the use of
external supports, walking aids, and braces that are intended to immobilize the fracture
site and limit weight bearing or load bearing. The patient is to be made fully aware and
warned that the device does not replace normal healthy bone, and that the device can
break, bend or be damaged as a result of stress, activity, load bearing, or weight bearing. The patient is to be made aware and warned of general surgical risks, possible adverse
effects, and to follow the instructions of the treating physician. The patient is to be
advised of the need for regular postoperative follow-up examination as long as the
device remains implanted.
PRECAUTIONS
Do not reuse implants. While an implant may appear undamaged, previous stress may have
created imperfections that would reduce the service life of the implant. Do not treat with
implants that have been even momentarily placed in a different patient.
Instruments are available to aid in the accurate implantation of internal fixation devices. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments
are subject to wear with normal usage. Instruments, which have experienced extensive use or
excessive force, are susceptible to fracture. Surgical instruments should only be used for their
intended purpose. Arthrotek recommends that all instruments be regularly inspected for wear
and disfigurement.
If device contains MaxBraid™ suture, refer to manufacturer package insert for
further information.
POSSIBLE ADVERSE EFFECTS
1. Nonunion or delayed union, which may lead to breakage of the implant.
2. Bending or fracture of the implant.
3. Loosening or migration of the implant.
4. Metal sensitivity, or allergic reaction to a foreign body.
5. Pain, discomfort, or abnormal sensation due to the presence of the device.
6. Nerve damage due to surgical trauma.
7. Necrosis of bone or tissue.
8. Inadequate healing.
9. Intraoperative or postoperative bone fracture and/or postoperative pain.
STERILITY
Arthrotek® internal fixation implants are typically supplied sterile and are sterilized by
exposure to a minimum dose of 25kGy of gamma radiation or by Ethylene Oxide Gas (ETO) if
device contains MaxBraid™ PE suture. If supplied sterile, do not resterilize the implant. If not supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use. Do not sterilize UHMWPE implants using steam autoclaving methods. Do not use implants after
expiration date. Pre-VacuumSteam (HI-VAC) -- wrapped or unwrapped
Temperature 270°-275° F (132°-135°C)
Exposure Time
5 Minutes
Drying Time 8 Minutes
Since Arthrotek is not familiar with individual hospital handling methods, cleaning methods
and bioburden, Arthrotek cannot assume responsibility for sterility even though the guideline
is followed.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
1. Correct selection of the implant is extremely important. The potential for success in
soft tissue to bone fixation is increased by the selection of the proper type of implant. While proper selection can help minimize risks, neither the device nor grafts, when used
are designed to withstand the unsupported stress of full weight bearing, load bearing
or excessive activity.
2. The implants can loosen or be damaged and the graft can fail when subjected to
increased loading associated with nonunion or delayed union. If healing is delayed,
or does not occur, the implant or the procedure may fail. Loads produced by weight
bearing, and activity levels may dictate the longevity of the implant.
Authorized Representative: Biomet U.K., Ltd.
Waterton Industrial Estates,
Bridgend, South Wales
CF31 3XA, U. K.
СЄ0086
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that
date. To obtain a current package insert, please use the contact information provided herein.
Ordering Information
Bio-Core™ Interference Screw
905635
905636
905637
905638
905639
905640
905641
905642
905643
905644
905645
905646
7 x 20mm
7 x 25mm
7 x 30mm
8 x 20mm
8 x 25mm
8 x 30mm 9 x 20mm
9 x 25mm
9 x 30mm
10 x 20mm
10 x 25mm
10 x 30mm
Poly Suture Button
904215
904219
15mm
19mm
Resorbable No-Profile Screw
905401
905402
905403
905404
905405
905406
905407
6.5 x 25mm
6.5 x 30mm
6.5 x 35mm
6.5 x 40mm
6.5 x 45mm
6.5 x 50mm
6.5 x 55mm
No-Profile Cancellous Screw
904530
904535
904540
904545
904550
904555
904560
904565
904570
6.5 x 30mm
6.5 x 35mm
6.5 x 40mm
6.5 x 45mm
6.5 x 50mm
6.5 x 55mm
6.5 x 60mm
6.5 x 65mm
6.5 x 70mm
No-Profile Cortical Screw (Self Tapping)
904630
904632
904634
904636
904638
904640
904642
904644
904646
904648
904650
904652
904654
904656
904658
904660
6.5 x 30mm
6.5 x 32mm
6.5 x 34mm
6.5 x 36mm
6.5 x 38mm
6.5 x 40mm
6.5 x 42mm
6.5 x 44mm
6.5 x 46mm
6.5 x 48mm
6.5 x 50mm
6.5 x 52mm
6.5 x 54mm
6.5 x 56mm
6.5 x 58mm
6.5 x 60mm
Resorbable No-Profile Spiked Washer
905418
No-Profile Spiked Washer
18mm
904414
904418
904420
14mm
18mm
20mm
No-Profile Flat Washer
904428
18mm
Fanelli™ PCL/ACL Guide
909800 Body
909804 PCL Bullet
Fanelli™ Magellan
909808
Calibrated Probe
909799
Tunnel Awl
909798
Curved Rasp
909791
Cupped Curette
909792
Cupped Curette (Over the Back)
909793
Open Curette
909794
Open Curette (Over the Back)
909795
PCL Capsule Rasp
909790
Hook Knife
909796
Graft Tensioning Boot
909525
Fanelli™ Double Bundle Aimer
909747 7mm
909748 8mm
909749 9mm
909750 10mm
909751 11mm
909752 12mm
Femoral Aimer
909627 7mm
909628 8mm
909629 9mm
909630 10mm
909631 11mm
909632 12mm
Femoral Aimer Handle
909623
Femoral Aimer Replacement Ring Nut
909627-03
Cannulated Drill Bit
909911 7mm
909913 8mm
909915 9mm
909917 10mm
909919 11mm
909921 12mm
Graft Sizing Block
906820
Cannulated End Cutting Reamer
909617 7mm
909618 8mm
909619 9mm
909620 10mm
909621 11mm
909622 12mm
P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 • ©2006 Arthrotek, Inc. All Rights Reserved
web site: www.arthrotek.com • eMail: [email protected]
Form No. Y-BMT-979/071506/K
I N V E N T I N G
T H E
F U T U R E
O F
A R T H R O S C O P Y