Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement

Study Overview
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Brief Summary
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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 replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

Detailed Description
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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 arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.

Official Title
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Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: zirconia femoral component
* Device: cobalt chrome femoral component


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: zirconia femoral component<br>* total knee arthroplasty performed using implant with zirconia femoral component<br>|
| Active Comparator: 2<br> | Device: cobalt chrome femoral component<br>* total knee arthroplasty performed using implant with cobalt chrome femoral component<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Score at 2 Years Post Operation | The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success. | within 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, osteoarthritis, ceramic bearing, zirconia