Evaluation of the VEGA Knee System® Range of Motion

Terminated

• Conditions: Patients With Total Knee Arthroplasty Using the VEGA System

• Registration Number: NCT01768871
• Lead Sponsor: Aesculap Implant Systems

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®.

Detailed Description

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-16
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC	Two years	WOMAC function score 2 years post arthroplasty

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	Two years

Trial Locations

Locations (3)

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

Charles J DePaolo, MD, PA; 🇺🇸 Asheville, North Carolina, United States

DBA Hussamy Sports and Hand Center; 🇺🇸 Vero Beach, Florida, United States