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Evaluation of the VEGA Knee System® Range of Motion

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ClinicalTrials.gov Identifier: NCT01768871
Recruitment Status : Terminated (low enrollment)
First Posted : January 16, 2013
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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®.

Condition or disease
Patients With Total Knee Arthroplasty Using the VEGA System

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

Study Design

Study Type : Observational
Actual Enrollment : 7 participants
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.
Study Start Date : January 2013
Primary Completion Date : July 2015
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. WOMAC [ Time Frame: Two years ]
    WOMAC function score 2 years post arthroplasty


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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: January 16, 2013    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017