Evaluation of the VEGA Knee System® Range of Motion

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Aesculap Implant Systems
ClinicalTrials.gov Identifier:
NCT01768871
First received: January 14, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.


Condition
Patients With Total Knee Arthroplasty Using the VEGA System®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Long-Term, Multi-Center Study on the Efficacy of the VEGA System® for Total Knee Arthroplasty.

Resource links provided by NLM:


Further study details as provided by Aesculap Implant Systems:

Primary Outcome Measures:
  • WOMAC [ Time Frame: Two years ] [ Designated as safety issue: No ]
    WOMAC function score 2 years post arthroplasty


Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: January 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Detailed Description:

To evaluate patients after total knee arthroplasty in terms of function for five years.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone a total knee arthroplasty with the VEGA knee system®

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.
  Contacts and Locations
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

Locations
United States, Colorado
Rose Medical Center
Denver, Colorado, United States, 80220
United States, Florida
DBA Hussamy Sports and Hand Center
Vero Beach, Florida, United States, 32960
United States, North Carolina
Charles J DePaolo, MD, PA
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Aesculap Implant Systems
Investigators
Study Chair: Khaled Saleh Southern Illinois University School of Medicine
  More Information

No publications provided

Responsible Party: Aesculap Implant Systems
ClinicalTrials.gov Identifier: NCT01768871     History of Changes
Other Study ID Numbers: AAG-O-H-1105
Study First Received: January 14, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014