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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:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT00917774
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
History of Changes
  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 Blind (Subject, 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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • knee function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • implant fit to patient [ Time Frame: 2 year ] [ Designated as safety issue: No ]

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

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

No publications provided

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
Study First Received: June 9, 2009
Last Updated: June 11, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 16, 2013