Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment knee implant
Phase phase 4
Sponsor Nova Scotia Health Authority
Start date January 2003
End date December 2015
Trial size 186 participants
Trial identifier NCT00351793, CDHA-RL-004

Summary

The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
knee implant
Total knee replacement with Genesis II posterior stabilized knee
knee implant
Total knee replacement with Genesis II posterior stabilized knee

Primary Outcomes

Measure
Effectiveness and Safety
time frame: 5 years

Secondary Outcomes

Measure
Knee Society Clinical Rating
time frame: Pre-op, 6 months, 1 year, 2 years, 5 years
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
time frame: Pre-op, 6 months, 1 year, 2 years, 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - A combined deformity of <30 degrees = group 1 - A combined deformity of >30 degrees = group 2 - Patient is willing to consent to participate in the study - Patient is available for follow-up through at least 2 years but preferably 5 years - Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk - Patients who are fluent in English and are able to understand their role in a clinical trial Exclusion Criteria: - Active, local infection or systemic infection - Fibromyalgia patients - Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule

Additional Information

Official title A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Principal investigator Ross K Leighton, MD, FRCS(C)
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.