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Completed

NCT Number: NCT00916968

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard CR-Flex total knee

Device

total knee implant used for joint replacement surgery of the knee

Other names: Zimmer, Nexgen CR-flex

Gender specific CR-Flex

Device

TKA by Gender specific Nexgen CR-Flex

Other names: Gender Specific Nexgen CR-Flex implant

Primary outcomes

  1. Knee Society Knee Score

    Time frame: 2 years

Secondary outcomes

  1. Implant or bone overhang

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Acronym: CR

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jun 10, 2009
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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