NCT01768871
Terminated
Not Applicable
Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
Aesculap Implant Systems3 sites in 1 country7 target enrollmentJanuary 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients With Total Knee Arthroplasty Using the VEGA System
- Sponsor
- Aesculap Implant Systems
- Enrollment
- 7
- Locations
- 3
- Primary Endpoint
- WOMAC
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
Detailed Description
To evaluate patients after total knee arthroplasty in terms of function for five years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •willing to sign the informed consent.
- •Patient has intact collateral ligaments.
Exclusion Criteria
- •Inflammatory arthritis
- •Patients that have had a high tibial osteotomy or femoral osteotomy
- •Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.
Outcomes
Primary Outcomes
WOMAC
Time Frame: Two years
WOMAC function score 2 years post arthroplasty
Secondary Outcomes
- Health related quality of life(Two years)
Study Sites (3)
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