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

NCT ID: NCT00916968

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard CR-Flex

Group Type ACTIVE_COMPARATOR

Standard CR-Flex total knee

Intervention Type DEVICE

total knee implant used for joint replacement surgery of the knee

Gender specific CR-Flex

Group Type EXPERIMENTAL

Gender specific CR-Flex

Intervention Type DEVICE

TKA by Gender specific Nexgen CR-Flex

Interventions

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Standard CR-Flex total knee

total knee implant used for joint replacement surgery of the knee

Intervention Type DEVICE

Gender specific CR-Flex

TKA by Gender specific Nexgen CR-Flex

Intervention Type DEVICE

Other Intervention Names

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Zimmer, Nexgen CR-flex Gender Specific Nexgen CR-Flex implant

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Ewha Womans University Mokdong Hospital Joint Replacement Center

Principal Investigators

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Yoowang Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-6-9

Identifier Type: -

Identifier Source: org_study_id

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