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Completed

NCT Number: NCT00917774

A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Female Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

About this study

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.

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 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

Treatment and study plan

Standard LPS flex TKA

Device

TKA by Standard LPS flex TKA

Other names: Standard Zimmer Nexgen Legacy posterior stabilized High-flex

Gender specific LPS -Flex TKA

Device

Total knee design created specific for female patients

Other names: Gender specific Zimmer LPS High-flex

Primary outcomes

  1. knee function

    Time frame: 2 years

Secondary outcomes

  1. implant fit to patient

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Jun 10, 2009
Registry last updated
Jun 12, 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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