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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zirconia femoral component

Device

total knee arthroplasty performed using implant with zirconia femoral component

cobalt chrome femoral component

Device

total knee arthroplasty performed using implant with cobalt chrome femoral component

Primary outcomes

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".

Sponsors and collaborators

Lead sponsor

Kinamed Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2012
Study completion: 2012
First posted: Aug 29, 2008
Registry last updated: May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed