Status:
COMPLETED
Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement
Lead Sponsor:
Kinamed Incorporated
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee repl...
Detailed Description
Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplast...
Eligibility Criteria
Inclusion
- Skeletally mature
- Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
- Stable or reconstructable collateral and posterior cruciate ligaments
- Correctable deformity
- Intact quadriceps and hamstrings mechanisms
- Patella bone thick enough (at least 15 mm) after resection
Exclusion
- Previous TKA
- Bilateral knee arthritis
- Non-availability for follow-up
- Mental incompetence or confinement
- Patients being treated with other investigational devices for same disorder
- Infection
- Osteoporosis, acute renal failure, or other disorders known to affect bone quality
- Charcot's or Paget's disease
- Patient physical condition preventing use of appropriate size implant
- Disease conditions affecting blood supply to knee
- Insufficient bone quality or quantity
- Physical condition predisposing implant to extreme loads
- History of septic knee arthritis
- History of drug abuse
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00743717
Start Date
February 1 2004
End Date
December 1 2012
Last Update
May 27 2013
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