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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916968
First Posted: June 10, 2009
Last Update Posted: July 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ewha Womans University
  Purpose
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.

Condition Intervention Phase
Osteoarthritis Device: Standard CR-Flex total knee Device: Gender specific CR-Flex Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Knee Society Knee Score [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Implant or bone overhang [ Time Frame: 2 years ]

Enrollment: 146
Study Start Date: February 2007
Study Completion Date: May 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard CR-Flex Device: Standard CR-Flex total knee
total knee implant used for joint replacement surgery of the knee
Other Name: Zimmer, Nexgen CR-flex
Experimental: Gender specific CR-Flex Device: Gender specific CR-Flex
TKA by Gender specific Nexgen CR-Flex
Other Name: Gender Specific Nexgen CR-Flex implant

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916968


Locations
Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Yoowang Choi, MD Ewha Womans University Mokdong Hospital
  More Information

Responsible Party: Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center
ClinicalTrials.gov Identifier: NCT00916968     History of Changes
Other Study ID Numbers: 2009-6-9
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: July 2, 2009
Last Verified: June 2009

Keywords provided by Ewha Womans University:
Gender specific
cruciate retaining
total knee arthroplasty
Bilateral Osteoarthritis of the knee joint

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases