Evaluation of the VEGA Knee System® Range of Motion
This study has been terminated.
Information provided by (Responsible Party):
Aesculap Implant Systems
First received: January 14, 2013
Last updated: October 28, 2013
Last verified: October 2013
The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.
Patients With Total Knee Arthroplasty Using the VEGA System®
||Observational Model: Cohort
Time Perspective: Prospective
||Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
Primary Outcome Measures:
Secondary Outcome Measures:
- Health related quality of life [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
To evaluate patients after total knee arthroplasty in terms of function for five years.
|Ages Eligible for Study:
||21 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients who have undergone a total knee arthroplasty with the VEGA knee system®
- willing to sign the informed consent.
- Patient has intact collateral ligaments.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768871
|Rose Medical Center
|Denver, Colorado, United States, 80220 |
|DBA Hussamy Sports and Hand Center
|Vero Beach, Florida, United States, 32960 |
|Charles J DePaolo, MD, PA
|Asheville, North Carolina, United States, 28801 |
Aesculap Implant Systems
||Southern Illinois University School of Medicine
No publications provided
ClinicalTrials.gov processed this record on August 18, 2014
||Aesculap Implant Systems
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 14, 2013
||October 28, 2013
||United States: Food and Drug Administration