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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00917774

Enrollment

Registered

2009-06-10

Start date

2006-11-30

Completion date

2009-05-31

Last updated

2009-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female, Osteoarthritis of the Knee

Keywords

gender specific knee, osteoarthritis, total knee arthroplasty

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.

Interventions

DEVICEStandard LPS flex TKA

TKA by Standard LPS flex TKA

DEVICEGender specific LPS -Flex TKA

Total knee design created specific for female patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
knee function	2 years

Secondary

Measure	Time frame
implant fit to patient	2 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026