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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917774
First Posted: June 10, 2009
Last Update Posted: June 12, 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 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.

Condition Intervention Phase
Osteoarthritis of the Knee Female Device: Standard LPS flex TKA Device: Gender specific LPS -Flex TKA Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • knee function [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • implant fit to patient [ Time Frame: 2 year ]

Enrollment: 88
Study Start Date: November 2006
Study Completion Date: May 2009
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard LPS Flex
Nexgen LPS-Flex total knee design used for TKA
Device: Standard LPS flex TKA
TKA by Standard LPS flex TKA
Other Name: Standard Zimmer Nexgen Legacy posterior stabilized High-flex
Experimental: Gender specific LPS-Flex
Gender specific LPS flex design used for TKA in female patients
Device: Gender specific LPS -Flex TKA
Total knee design created specific for female patients
Other Name: Gender specific Zimmer LPS High-flex

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.
  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT00917774


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: NCT00917774     History of Changes
Other Study ID Numbers: 2009-6-10
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by Ewha Womans University:
gender specific knee
osteoarthritis
total knee arthroplasty

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