Phase 2 Completed N=4 Randomized Single-blind Treatment

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

Knee Osteoarthritis

Source: ClinicalTrials.gov NCT00743717 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcomePrimary: Knee Score at 2 Years Post Operation — 91; 89 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Knee Score at 2 Years Post Operation	91; 89	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.