Study Stopped
low enrollment
Evaluation of the VEGA Knee System® Range of Motion
Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.
1 other identifier
observational
7
1 country
3
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 14, 2018
November 1, 2018
2.5 years
January 14, 2013
November 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
WOMAC
WOMAC function score 2 years post arthroplasty
Two years
Secondary Outcomes (1)
Health related quality of life
Two years
Eligibility Criteria
Patients who have undergone a total knee arthroplasty with the VEGA knee system®
You may qualify if:
- willing to sign the informed consent.
- Patient has intact collateral ligaments.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rose Medical Center
Denver, Colorado, 80220, United States
DBA Hussamy Sports and Hand Center
Vero Beach, Florida, 32960, United States
Charles J DePaolo, MD, PA
Asheville, North Carolina, 28801, United States
Study Officials
- STUDY CHAIR
Khaled Saleh
Southern Illinois University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 16, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 14, 2018
Record last verified: 2018-11