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Evaluation of the VEGA Knee System® Range of Motion

This study is currently recruiting participants.
Verified January 2013 by Aesculap Implant Systems
Sponsor:
Information provided by (Responsible Party):
Aesculap Implant Systems
ClinicalTrials.gov Identifier:
NCT01768871
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  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:

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

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 ]

Estimated Enrollment: 100
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768871

Locations
United States, Colorado
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: John Papillion     303-344-9090        
Principal Investigator: John Papillion            
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: January 15, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013