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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kinamed Incorporated
ClinicalTrials.gov Identifier:
NCT00743717
First received: August 27, 2008
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Device: zirconia femoral component
Device: cobalt chrome femoral component
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System

Resource links provided by NLM:


Further study details as provided by Kinamed Incorporated:

Primary Outcome Measures:
  • Knee Score at 2 Years Post Operation [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
    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".


Enrollment: 4
Study Start Date: February 2004
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743717

Sponsors and Collaborators
Kinamed Incorporated
Investigators
Study Director: Vineet Sarin, PhD Kinamed Incorporated
  More Information

No publications provided

Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00743717     History of Changes
Other Study ID Numbers: G010204
Study First Received: August 27, 2008
Results First Received: February 27, 2013
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Kinamed Incorporated:
total knee arthroplasty
osteoarthritis
ceramic bearing
zirconia

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014