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

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis of the Knee; Female

Treatments: Device: Gender specific LPS -Flex TKA; Device: Standard LPS flex TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT00917774

2009-6-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Standard LPS Flex

Active Comparator group

Description:

Nexgen LPS-Flex total knee design used for TKA

Treatment:

Device: Standard LPS flex TKA

Gender specific LPS-Flex

Experimental group

Description:

Gender specific LPS flex design used for TKA in female patients

Treatment:

Device: Gender specific LPS -Flex TKA