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Evaluation of the VEGA Knee System® Range of Motion

This study has been terminated.
(low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768871
First Posted: January 16, 2013
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aesculap Implant Systems
  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 ]
    WOMAC function score 2 years post arthroplasty


Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: Two years ]

Enrollment: 7
Study Start Date: January 2013
Estimated Study Completion Date: July 2020
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aesculap Implant Systems
ClinicalTrials.gov Identifier: NCT01768871     History of Changes
Other Study ID Numbers: AAG-O-H-1105
First Submitted: January 14, 2013
First Posted: January 16, 2013
Last Update Posted: January 27, 2017
Last Verified: January 2017