MedPath

Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses

Phase 4
Completed
Conditions
Osteoarthritis
Interventions
Device: Standard CR-Flex total knee
Device: Gender specific CR-Flex
Registration Number
NCT00916968
Lead Sponsor
Ewha Womans University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
146
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard CR-FlexStandard CR-Flex total knee-
Gender specific CR-FlexGender specific CR-Flex-
Primary Outcome Measures
NameTimeMethod
Knee Society Knee Score2 years
Secondary Outcome Measures
NameTimeMethod
Implant or bone overhang2 years

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital

🇰🇷

Seoul, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath