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

Phase 4

Completed

• Conditions: Osteoarthritis of the Knee; Female
• Interventions: Device: Standard LPS flex TKA; Device: Gender specific LPS -Flex TKA

• Registration Number: NCT00917774
• Lead Sponsor: Ewha Womans University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-01
• Study Completion: 2009-05
• Status Verified: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Last Update Submitted: 2009-06-11
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard LPS Flex	Standard LPS flex TKA	Nexgen LPS-Flex total knee design used for TKA
Gender specific LPS-Flex	Gender specific LPS -Flex TKA	Gender specific LPS flex design used for TKA in female patients

Primary Outcome Measures

Name	Time	Method
knee function	2 years

Secondary Outcome Measures

Name	Time	Method
implant fit to patient	2 year

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of