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Clinical Trials/NCT00917774
NCT00917774
Completed
Phase 4

A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function Compared With a Standard Posterior Cruciate-Substituting High-Flexion Knee Prostheis A Prospective, Randomized Study

Ewha Womans University1 site in 1 country88 target enrollmentNovember 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis of the Knee
Sponsor
Ewha Womans University
Enrollment
88
Locations
1
Primary Endpoint
knee function
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Detailed Description

Recently much debate and discussion has focused on the effect of gender-specific total knee arthroplasty. The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
May 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease, in female patients

Exclusion Criteria

  • Male patient
  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery

Outcomes

Primary Outcomes

knee function

Time Frame: 2 years

Secondary Outcomes

  • implant fit to patient(2 year)

Study Sites (1)

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