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

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Device: Standard CR-Flex total knee; Device: Gender specific CR-Flex

Study type: Interventional

Funder types: Other

Identifiers

NCT00916968

2009-6-9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 2 patient groups

Standard CR-Flex

Active Comparator group

Treatment:

Device: Standard CR-Flex total knee

Gender specific CR-Flex

Experimental group

Treatment:

Device: Gender specific CR-Flex