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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743717
• Other study ID #: G010204
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: May 21, 2013
• Start date: February 2004
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Kinamed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• zirconia femoral component
total knee arthroplasty performed using implant with zirconia femoral component
• cobalt chrome femoral component
total knee arthroplasty performed using implant with cobalt chrome femoral component

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kinamed Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No