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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00916968

Acronym

Enrollment

146

Registered

2009-06-10

Start date

2007-02-28

Completion date

2009-05-31

Last updated

2009-07-02

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

Conditions

Osteoarthritis

Keywords

Gender specific, cruciate retaining, total knee arthroplasty, Bilateral Osteoarthritis of the knee joint

Brief summary

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.

Detailed description

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.

Interventions

DEVICEStandard CR-Flex total knee

total knee implant used for joint replacement surgery of the knee

DEVICEGender specific CR-Flex

TKA by Gender specific Nexgen CR-Flex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Knee Society Knee Score	2 years

Secondary

Measure	Time frame
Implant or bone overhang	2 years

Countries

South Korea

Outcome results

None listed

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