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Clinical Trials/NCT00916968
NCT00916968
Completed
Phase 4

Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study

Ewha Womans University1 site in 1 country146 target enrollmentFebruary 2007
ConditionsOsteoarthritis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Ewha Womans University
Enrollment
146
Locations
1
Primary Endpoint
Knee Society Knee Score
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Detailed Description

The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
May 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria

  • Inflammatory arthritis
  • Osteoarthritis effecting hip joint
  • Traumatic arthritis
  • Neurologic disorders affecting motor function of lower extremity
  • foot and ankle disorders limiting ambulation of the patient

Outcomes

Primary Outcomes

Knee Society Knee Score

Time Frame: 2 years

Secondary Outcomes

  • Implant or bone overhang(2 years)

Study Sites (1)

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