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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00743717
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : May 22, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Kinamed Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: zirconia femoral component Device: cobalt chrome femoral component Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
Study Start Date : February 2004
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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".


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743717


Sponsors and Collaborators
Kinamed Incorporated
Investigators
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Study Director: Vineet Sarin, PhD Kinamed Incorporated
More Information
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Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00743717    
Other Study ID Numbers: G010204
First Posted: August 29, 2008    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Kinamed Incorporated:
total knee arthroplasty
osteoarthritis
ceramic bearing
zirconia
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Cobalt
Trace Elements
Micronutrients
Physiological Effects of Drugs