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

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: zirconia femoral component; Device: cobalt chrome femoral component

• Registration Number: NCT00743717
• Lead Sponsor: Kinamed Incorporated

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 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

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-29
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-02-27
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-21
• Results First Posted: 2013-05-22
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	zirconia femoral component	-
2	cobalt chrome femoral component	-

Primary Outcome Measures

Name	Time	Method
Knee Score at 2 Years Post Operation	within 2 years	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".