Osteoarthritis
Conditions
Brief summary
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.
Interventions
DEVICEKnee Implant
Total knee replacement with Genesis II posterior stabilized knee
Sponsors
Nova Scotia Health Authority
Ross Leighton
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness and Safety | 5 years | Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation |
Secondary
| Measure | Time frame |
|---|---|
| Knee Society Clinical Rating | Pre-op, 6 months, 1 year, 2 years, 5 years |
| Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) | Pre-op, 6 months, 1 year, 2 years, 5 years |
Countries
Canada
Outcome results
None listed