Status:
COMPLETED
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Lead Sponsor:
Ross Leighton
Collaborating Sponsors:
Nova Scotia Health Authority
Conditions:
Osteoarthritis
Eligibility:
All Genders
Brief Summary
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00351793
Start Date
January 1 2003
End Date
July 1 2021
Last Update
November 9 2022
Active Locations (1)
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1
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7