Patients With Total Knee Arthroplasty Using the VEGA System Clinical Trial
Official title:
Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
| NCT number | NCT01768871 |
| Other study ID # | AAG-O-H-1105 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | July 2015 |
| Verified date | November 2018 |
| Source | Aesculap Implant Systems |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Charles J DePaolo, MD, PA | Asheville | North Carolina |
| United States | Rose Medical Center | Denver | Colorado |
| United States | DBA Hussamy Sports and Hand Center | Vero Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Aesculap Implant Systems |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | WOMAC | WOMAC function score 2 years post arthroplasty | Two years | |
| Secondary | Health related quality of life | Two years |