3. Introduction:
▪ Although replacing the total knee joint is the most
common procedure, some people can benefit from just a
partial knee replacement.
▪ Implants are made of metal alloys, ceramic material, or
strong plastic parts, and can be joined to bones by
acrylic cement.
▪ Several manufacturers make knee implants and there are
more than 150 knee replacement designs on the market
today.
7. Implant materials:
▪ Metal parts: titanium or
cobalt-chromium based
alloys.
▪ Plastic part: ultra high
molecular weight
polyethylene
▪ Cemented fixation:
polymethylmethacrylate
▪ hybrid fixation:
femoral component:
without cement
tibial and patellar
components: with cement.
8. Indications for Knee Replacement Surgery:
Knee pain that hinders walking, climbing stairs,
or getting in and out of a chair
Knee pain that interferes with sleep or does not
subside with rest
Inability to cope with side effects of pain relief
medication
Knee swelling that does not respond to treatment
and that limits bending or straightening the knee
Significant bowing in or out of the knee
Osteoarthritis severe cases
9. Risk and complications of replacement surgery
Complications from Anesthesia:
Most common side effects:
▪ vomiting
▪ dizziness
▪ shivering
▪ sore throat
▪ aches and pains
▪ discomfort
▪ drowsiness
Negative reactions:
▪ dental trauma
▪ croup (swelling of the windpipe)
▪ allergic reactions to latex
▪ wheezing
▪ vocal cord injury
▪ stomach problems
▪ injuries to arteries, veins, or nerves
10. Blood Clots:
• deep vein thrombosis (DVT) and pulmonary embolism (PE)
• typically occur within two weeks of surgery
• they can also take place within a few hours or even in the
operating room
• smoking or obesity, increase the risk.
11. Infection:
• The number of people who get an infection after a
knee replacement is very low
• People with rheumatoid arthritis or diabetes have a greater
risk of infection in the weeks following a procedure because
of their altered immune system
• Infection in another part of the body at the time of a
knee operation, could lead to an infection in the knee
months or even years later
12. Complications from a Transfusion
•hives
•fever
•chills
•shortness of breath
•red urine
Signs and symptoms of an adverse transfusion reaction
usually occur within 24 hours
13. Allergy to Metal Components
Wound and Bleeding Complications
Artery Injuries
Nerve or Neurovascular Damage
Knee Stiffness and Loss of Motion in the Knee
14. Prosthesis Problems and Implant Failure
• Improper placement or a malfunction of the implant:
-new knee might not bend properly
-the prosthesis might loosen from the bone over the long-
term
-Other parts in the artificial knee could break down
• These failures are extremely rare
• Revision surgery is usually required to fix the problem
when this does happen
15. Mortality:
• The risk of death from knee replacement is very low, but it
does occur
• A 2010 study published in the Journal of Bone and Joint
Surgery estimated the risk of mortality to be 0.1 percent
• The risk is highest during the first month after surgery
16. Risks/ Benefits
Benefits:
▪Pain relief
▪Improve joint
function
Risks:
▪The same dangers as
other major surgeries
▪The new joint may not
work as well as hoped
▪Implant becomes loose
or dislocates
17. Price Estimates
▪Including room fee,
nurse fee, food, pre-
op tests, medical
supplies,
medication,
operating room fee,
x-rays, and
consulation
Country Price (USD)
United States $45,000-$60,000
Singapore $18,000-$22,500
Thailand $12,000-$14,200
Taiwan $9,000 – $10,100
India $7,000 – $11,200
18. Cost of a knee replacement in selected countries as of 2015 (in U.S. dollars)
19. Clinical Trial: Phase-4 Study
ConforMIS iTotal® (CR) Knee
Replacement System Versus Off-the-
Shelf Replacement
21. Traditional knee
replacements come in
standardized sizes
which require shaving
the femur bone to fit
the implant
iTotal knee
replacement implants
are custom made to
fit each individual
patient
22. Purpose:
• Patients will be randomized to either
ConforMIS iTotal Knee Replacement or Off the
Shelf knee replacement
• The patient will conduct functional testing and
answer questionnaires
• The results will compare the ConforMIS iTotal
with an Off the Shelf Knee replacement
24. Estimated Enrollment: 800
Study Start Date: July 2015
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date:
August 2016 (primary outcome measure)
25. Primary Outcome Measures:
• Functional Testing after 1 year
• Comparing the functional testing
differences between iTotal and off the
shelf
26. Secondary Outcome Measures:
•Patient reported outcome using questionnaires
•Incidents of major procedure-related and device
related complications
•Post-operative limb alignment based using x-ray
28. Exclusion Criteria:
• Subject will require a simultaneous bilateral procedure
• Other lower extremity surgery within 1 year
• Severe (> 15º) fixed valgus or varus deformity
• Severe (> 15º) extension deficit
• Severe instability due to advanced loss of osteochondral structure
• Loss of bone or musculature, osteoporosis, neuromuscular or
vascular compromise in the area of the joint to be operated on to an
extent that the procedure is unjustified
• Insufficient bone stock on the femoral or tibial surfaces
• Contralateral knee replacement surgery within the past 6 months
• BMI > 40
29. • Active malignancy
• Poorly controlled diabetes
• Immunocompromised
• Other physical disability affecting the hips, spine, or
contralateral knee that limits function
• Disabling chronic pain with narcotic dependence
• Compromised PCL or collateral ligament
• Prior history of failed implant surgery
• Prior history of failed high tibial osteotomy (HTO)
• Participation in another clinical study which would
confound results
• Inability to complete the protocol