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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

June 9, 2009
June 11, 2009
November 2006
January 2007   (final data collection date for primary outcome measure)
knee function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00917774 on ClinicalTrials.gov Archive Site
implant fit to patient [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis of the Knee
  • Female
  • Device: Standard LPS flex TKA
    TKA by Standard LPS flex TKA
    Other Name: Standard Zimmer Nexgen Legacy posterior stabilized High-flex
  • Device: Gender specific LPS -Flex TKA
    Total knee design created specific for female patients
    Other Name: Gender specific Zimmer LPS High-flex
  • Active Comparator: Standard LPS Flex
    Nexgen LPS-Flex total knee design used for TKA
    Intervention: Device: Standard LPS flex TKA
  • Experimental: Gender specific LPS-Flex
    Gender specific LPS flex design used for TKA in female patients
    Intervention: Device: Gender specific LPS -Flex TKA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
May 2009
January 2007   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00917774
2009-6-10
Yes
Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center
Ewha Womans University
Not Provided
Principal Investigator: Yoowang Choi, MD Ewha Womans University
Ewha Womans University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP