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

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT00916968
First received: June 9, 2009
Last updated: July 1, 2009
Last verified: June 2009
  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: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implant or bone overhang [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 9, 2009
Last Updated: July 1, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on July 24, 2014