Relieving Arthritis Knee Pain Treatment Options

UNDERSTANDING
YOUR KNEE
Healthy Knee Anatomy
Relieving Arthritis Knee
Pain
Your knee joint is formed by the intersection of the femur (thigh
bone), the tibia (shin bone), and the patella (the knee cap).
These bones form three “compartments” or sections.
1.Medial compartment
(inner half of your knee)
•Lateral compartment
(outer half of your knee
•Patella femoral compartment
(behind the knee cap)
Michael P. Wertz, MD
In a normal functioning knee, each bone glides smoothly against
the other on a layer of cartilage that covers the
ends of the bone. In a knee joint affected by osteoarthritis,
the smooth cartilage lining on the inside of the joint
has worn away. Your surgeon can determine the
extent and severity of your OA.
4820 Riverbend Rd, Boulder
303-848-2460
Left Knee:
Osteoarthritis can
affect one, two or all
three compartments
of the knee.
Osteoarthritis: the Disease
Osteoarthritis (OA) is the most
common form of arthritis, affecting
tens of millions of people
worldwide.
It is a degenerative joint disease
characterized by the breakdown
and eventual loss of joint cartilage.
The breakdown and wearing away
of cartilage causes the bones to
rub together resulting in extreme
pain.
OA resulting from “wear and tear”
is the most common reason
individuals need to undergo
knee replacement surgery.
UNDERSTANDING
YOUR KNEE
Treatment
Options
• Medical Management
• Knee Injections
• Surgical Options
• Joint Replacement
Medical Management
• Health and behavior modification
– Weight loss to help decrease stress on the joints
– Exercise to help improve mobility
TREATMENT
OPTIONS
Knee Injections
• Corticosteroid (anti-inflammatory) injections for temporary
pain relief
• Hyaluronic acid injections (viscosupplementation – “WD 40”)
– Approved for 6 Month Relief
• Physical therapy
– Single injection or Multiple injection series
– PRP Platelet Rich Plasma
• Glucosamine and Chondroitin. Do they really work?
Arthroscopy. 2013 Dec;29(12):2037-48. doi: 10.1016/j.arthro.2013.09.006.
• Tylenol / NSAIDs for pain management
• Braces, canes and other assistive devices
The efficacy of platelet-rich plasma in the treatment of
symptomatic knee osteoarthritis: a systematic review with
quantitative synthesis.
Khoshbin A1, Leroux T, Wasserstein D, Marks P, Theodoropoulos J,
platelets contain alpha granules that are rich in several
growth factors, such as platelet-derived growth factor,
transforming growth factor-β, insulin-like growth factor,
vascular endothelial growth factor and epidermal growth
factor.
Stem Cells
Microfracture, Scaffolds and Patches
Injected
Cartiform
-What are they doing?
-attachment
-differentiation
Scapholds
-can control placement
-can modulate differentiation
TREATMENT
OPTIONS
TREATMENT
OPTIONS
Surgical Options
Artificial Meniscus
Polycarbonate Disk
in early trials
Arthroscopic Procedures
•Meniscus removal / repair
•artificial meniscus
•Debridement
Joint Realignment
•HTO
•Interpositional Device
Carticel
Joint Replacement:
Partial Knee Replacement
Unicompartmental Knee Arthroplasty
Harvested cartilage cells
(from previous
arthroscopy) are
expanded in cell cultures
Cells are reimplanted
under periosteal
membrane harvested
from tibia
TREATMENT
OPTIONS
Unicompartmental Knee Replacement
iUni® G2
PARTIAL KNEE IMPLANT
OPTIONS
The only patient-specific
unicompartmental knee replacement
Joint Replacement:
Partial Knee Replacement
TREATMENT
OPTIONS
Bicompartmental Knee Replacement
• Designed to treat medial or lateral
tibiofemoral osteoarthritis
• Provides a customized fit specific to your
knee
• Designed to mimic the natural shape of your
knee to help retain more of your natural
function
• Allows for a less traumatic procedure and
fewer bone cuts to preserve more of your
natural knee for future treatment, if necessary
Bicompartmental Knee Replacement
iDuo® G2
A revolutionary alternative to traditional
off-the-shelf TKR
• Designed to treat medial or lateral
tibiofemoral with patellofemoral osteoarthritis
• Combines proven TKR principles for
patellofemoral treatment with the advantages
of the ConforMIS partial knee system
• Treats just the affected knee compartments
with a precise, patient-specific implant that
delivers unparalleled fit, preserves all
ligaments and conserves far more bone than
traditional TKR
PARTIAL KNEE IMPLANT
OPTIONS
Joint Replacement:
Total Knee Replacement
Tricompartmental Knee Replacement
TREATMENT
OPTIONS
Patients Have Reported
Dissatisfaction with Traditional TKR
PATIENT-SPECIFIC KNEE
IMPLANTS
Leading Causes of Dissatisfaction
1 in 5 patients are not
satisfied with the results of
their total knee replacement.1
Residual Pain due to improper fit
and rotation
Patient-specific implants are
intended to address some of
the leading causes of patient
dissatisfaction.
Early Implant Failure due to poor
alignment and polyethylene wear
PATIENT-SPECIFIC KNEE
IMPLANTS
Functional Limitations due to
altered kinematics and instability
Off-the-Shelf
knee implants can have
painful overhang or
underhang because they
are not sized to fit each
patient.
PATIENT-SPECIFIC KNEE
IMPLANTS
Individualized Implant Fit
Patient specific implants fit
precisely by using CT scan data
to design an implant made for
each patient’s own knee.
•Patient-specific design that
virtually eliminates overhang
•Customized fit for every patient
Off-the-Shelf TKR
iTotal G2
Patient-Specific
Implant
iTotal® G2 Design Rationale
One patient. One implant.
© COPYRIGHT 2013 ConforMIS, Inc.
MK-02661-AG-10/13
iTotal® G2 Total Knee Replacement
System
Why iTotal?
PATIENT-SPECIFIC KNEE
IMPLANTS
Understanding Principle Drivers of Dissatisfaction
Designed to address some of the leading
causes of patient dissatisfaction
Early Implant Failure
• Leg alignment
• Poly wear
• Implant
engineering
• Designed for each individual based on your
anatomy
• Customized fit and alignment avoids sizing
compromises common with traditional offthe-shelf implants
Compromised
Function
Residual Pain
• Component fit
• Internal rotation of
the femur/tibia
• Limited range of
motion & stiffness
• Knee instability
• Proprioception
10-15% of TKA patients
have clinically
significant residual
pain1,2
Dissatisfied patients
report that their knee
does not feel normal at
more than 2x the rate
of satisfied patients3
• Designed to follow the shape and contour of
each patient’s knee to help restore natural
kinematics
Early failures only 12%, but significant
when they occur
• Designed for optimal bone preservation
• Cost is similar to standard total knee and
covered by many major insurance
companies
1 Brander
VA et al. Predicting total knee replacement pain: A prospective, observational study. Clin Orthop Relat Res. 2003;416:27-36.
2 Katz JN et al. Association Between Severe Pain in the Early Months Following Total Knee Replacement and Functional Outcomes Over Five-Year FollowUp. World Congress of OA. Abstract 80.
COPYRIGHT 2013 ConforMIS, Inc.
3 Noble PC et al. Patient expectations affect satisfaction with ©
MK-02661-AG-10/13
total
knee arthroplasty. Clin Orthop Relat Res. 2006;452:35-43.
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iAlignTM Alignment Approach for Jigs &
Implants
iTotal Design Rationale
Designed to Neutral Mechanical Axis
• Virtual alignment to mechanical
axis using anatomic landmarks
•Mechanical Axis Alignment
Virtual Alignment to
Mechanical Axis in Coronal
Plane
Hip
ØCenter of Hip
•Patient-Specific Fit & Positioning
ØCenter of Femur
ØCenter of Tibia
•Restoration of Articulating
Geometry
ØCenter of Ankle
•Bone Preservation
Knee
• Tibial Rotational Alignment
ØCT used to set to the anatomic
tibial axis
•Wear Optimized Design
Ankle
•Efficient Delivery Model
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iKneeTM Personalized Position, Shape &
Fit
Personalized Position, Shape & Fit
Patient matched, anatomic femur to avoid sizing compromises
Symmetric total knee designs force compromises between complete coverage and overhang.
Variations in anatomy make it virtually impossible to fit in all areas of the femur.
An iTotal femoral component has an
image based, patient specific design that
follows the anatomy
iTotal vs. Standard TKA Example
The personalized fit helps take surgeons out of
the sizing compromises typical in traditional
TKA
© COPYRIGHT 2013 ConforMIS, Inc.
© COPYRIGHT 2013 ConforMIS, Inc.
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Traditional Knee Replacement
Traditional Knee Replacement
The Challenge of Component Rotation
The Challenge of Tibial Rotation vs. Coverage
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Off-the-shelf tibial components force a compromise between maximal tibial
coverage and proper rotational alignment. When optimized for coverage1:
Implants were internally rotated an average of 8.8°
Only 30% were aligned within ±5° of proper rotation
Maximal
Coverage,
Improper
Rotation
J Bone Joint Surg BR. 2010;92-B:1238-44
© COPYRIGHT 2013 ConforMIS, Inc.
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1Martin
Off-the-Shelf
Designs
Proper Rotation,
Downsized to
Prevent
Overhang
S, Noble P. et al. Optimizing Tibial Coverage is Detrimental to Proper Rotational Alignment. AAHKS 2012: Poster #22
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Personalized Position, Shape & Fit
ENGINEERING THE CUSTOM TIBIA
Designed for proper rotation and fit to avoid known causes of
pain
Patient-Specific Shape & Fit
Rotational Alignment
Center of baseplate set to the center of the medial and lateral
condyles, shown to be a reliable method of tibial component
rotation1,2
1
2
3
Implant profile is then matched to cortical rim, with slight
relief to allow +/- 5º intra-operative adjustment without
implant overhang, a potential source of pain.3
Cobb JP; The Anatomical Tibial Axis – Reliable Rotational Orientation in Knee Replacement; J Bone Joint Surg [Br]; 2008;90-B:1032-8.
Lützner et al.: Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC
Musculoskeletal Disorders, 2010 11:57.
Chau R, et. al.,; Tibial component overhang following unicompartmental knee replacement - does it matter?; Knee; 2009; V16:pp. 310-313.
© COPYRIGHT 2013 ConforMIS, Inc.
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Respect Patient’s Condylar Geometry
Respect Patient’s Condylar Geometry
iShapeTM
Condylar Offset and Joint Line
Sagittal ‘J’ Curves
Studies have also shown that standard TKR geometry, including single radius designs, alter
knee kinematics.1 With iTotal, the patient’s anatomic ‘J’ curves, corrected for deformity,
provide the basis for the implant design.
Approximating a patient’s medial and lateral ‘J’ curves naturally retains their condylar offset.
Studies have shown that this offset occurs at comparable levels, and with comparable ranges,
across both OA and non-OA populations.1
Distal Offset
Patient’s natural articulating
geometry extracted from 3D
femoral anatomy
Curves are corrected for deformity
and then used as the basis for
femoral implant design
Posterior Offset
1 Hunter
1 Bull
DJ, Niu J, Felson DT, et al. Knee alignment does not predict incident osteoarthritis: the Framingham osteoarthritis study. Arthritis Rheum.
2007;56(4):1212-8.
AM, Kessler O, Alam M, et al. Changes in kinematics reflect the articular geometry after arthroplasty. Clin Orthop Relat Res. 2008;466(10):2491-9.
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Respect Patient’s Condylar Geometry
Respect Patient’s M/L Joint Line
Restores Normal Kinematics
Restores Normal Kinematics
Studies have shown that the natural Flexion-Extension Axis (FEA) and the
Transepicondylar Axis (TEA) are not the same and differ an average of 4.6 degrees1
iTotal respects each patient’s native condylar geometry, allowing the knee to rotate
about its natural axis
M/L joint line angle variability is high, 3.9⁰ +/- 4.0⁰ varus.1
Joint line movement has been shown to alter kinematics and lead to mid-flexion
instability2.
Rotation
required
Rotation
typically not
required
M/L Joint
Line Angle
TEA
TEA
FEA
Joint Line
Preserved
Joint line
altered
FEA
Off-the-Shelf TKR
iTotal
1Poilvache
1 Eckhoff
2
D et al. Difference Between the Epicondylar and Cylindrical Axis of the Knee. Clin Orthop Relat Res. 2007; Aug(461) 238-244.
© COPYRIGHT 2013 ConforMIS, Inc.
et al. Rotational Landmarks and Sizing of the Distal Femur in Total Knee Arthroplasty. Clin Orthop Relat Res 1996, 331, pp 35-46.
Martin J, Whiteside L. The Influence of Joint Line Position on Knee Stability After Condylar Knee Arthroplasty. Clin Orthop Relat Res 1990, 259, pp 146-156.
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Dual BalancingTM technology facilitates proper balancing of offset
6 Cut Design to Maximize Bone
Preservation
femur and joint line
Comparison to standard total knee systems
Femur Matched Offset Polys
Separate medial and
lateral poly inserts
matched to femoral
offset
3 lateral
thicknesses
(medial+offset)
Medium Size Femoral Implant
Thickness
3 medial
insert options
(6, 7, and 8mm)
(Measurements
A-P
Size
Length
in mm)
Offset helps mimic
varus angle of normal
tibial plateau
Medial insert more
conforming than
lateral insert to
facilitate rollback
28% volumetric
bone preservation
advantage for
iTotal
X-rays show two legs with
different offsets, but both
aligned to neutral mechanical
axis
*sample size is average of 5
representative designs matched
for AP length.
ConforMIS data on file.
© COPYRIGHT 2013 ConforMIS, Inc.
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Distal
Medial
Distal Posterior Posterior
Lateral
Medial
Lateral
ZMH NexGen
E
62
9
9
9.3
9.3
J&J PFC Sigma
3
61
9
9
8
8
SNN Legion
5
62
9.5
9.5
9.3
9.3
SYK Triathlon PS
4
62
8.5
8.5
8.5
8.5
SNN Journey
5
62
9.5
7.0
9.5
7.4
-
61.8
9.1
8.6
8.9
8.5
6.9
6.8
5.8
5.8
-2.2
-1.8
-3.1
-2.7
Average for
Sample
Average for
ConforMIS
62.0
Sample*
Delta (Standard
vs. ConforMIS)
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Traditional “Delivery Model”
Engineered Design Features
Extensive System Instrumentation in OR
Wear optimization and engineered function
High conformity dome
Patello-Femoral joint
8-12 trays of specialized
instrumentation required for a
joint replacement procedure
Extended trochlear groove
to guide patella in deep
flexion
Lowered lateral
trochlea to decompress
soft tissue
Knee Example
Wide coronal geometry for
high conformity to poly with
low constraint
© COPYRIGHT 2013 ConforMIS, Inc.
Intercondylar notch width driven
by patient anatomy rather than
need to accommodate upsizing
and downsizing
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All instrument trays opened
require set up, break down and
sterilization
Hip Example
COMPANY CONFIDENTIAL – INTERNAL USE
ONLY
© COPYRIGHT 2013 ConforMIS, Inc.
Traditional “Delivery Model”
ConforMIS “Delivery Model”
Extensive Hospital Inventory Management
A Model for a More Efficient Joint Replacement System
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Patient imaging
study at validated
center
3D Image
processing
Extensive implant
inventory storage &
management by OR
operations staff
COMPANY CONFIDENTIAL – INTERNAL USE
ONLY
Implant & instrument delivery to
the OR after sterilization and
prep by central supply
© COPYRIGHT 2013 ConforMIS, Inc.
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Implant
&®
iJig®
Implant
& iJig
design
design &
& manufacture
manufacture
One package
delivered for
Surgery
6 Week Delivery Time
Implant Request
Form (IRF)
submitted
COMPANY CONFIDENTIAL – INTERNAL USE
ONLY
© COPYRIGHT 2013 ConforMIS, Inc.
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ConforMIS “Delivery Model”
iFit® Image-to-Implant™ Technology
Efficient, Pre-Sterilized, Disposable
Single use kit
delivered a few days
before surgery
CONFORMIS
PATIENT-SPECIFIC
TECHNOLOGIES
Advances in Imaging
One reusable
instrument tray
iTotal G2 instrument
set and implants
provided for use in the
OR
COMPANY CONFIDENTIAL – INTERNAL USE
ONLY
© COPYRIGHT 2013 ConforMIS, Inc.
Joint Replacement
iFit video
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TREATMENT
OPTIONS
iTotal – True Patient Specific Fit and
Shape
What to Expect After Surgery
A typical patient should expect:
•You will be out of the hospital within 2 days and
then begin your rehabilitation
•You should be able to weight bear soon after
surgery, and walking with an aid at discharge
•Long-term results of knee surgery depend on
your work in rehabilitation
•By 6 weeks, you should be able to engage in
many of your typical daily activities
•More physical activities, such as sports may take
3 months to be able to do comfortably
© COPYRIGHT 2013 ConforMIS, Inc.
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