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

May 21, 2013 updated by: Kinamed Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Score at 2 Years Post Operation
Time Frame: 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".
within 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinamed Incorporated

Investigators

  • Study Director: Vineet Sarin, PhD, Kinamed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G010204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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