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

Primary Purpose

Osteoarthritis of the Knee, Female

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard LPS flex TKA
Gender specific LPS -Flex TKA
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring gender specific knee, osteoarthritis, total knee arthroplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard LPS Flex

Gender specific LPS-Flex

Arm Description

Nexgen LPS-Flex total knee design used for TKA

Gender specific LPS flex design used for TKA in female patients

Outcomes

Primary Outcome Measures

knee function

Secondary Outcome Measures

implant fit to patient

Full Information

First Posted
June 9, 2009
Last Updated
June 11, 2009
Sponsor
Ewha Womans University
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1. Study Identification

Unique Protocol Identification Number
NCT00917774
Brief Title
A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ewha Womans University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee, Female
Keywords
gender specific knee, osteoarthritis, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard LPS Flex
Arm Type
Active Comparator
Arm Description
Nexgen LPS-Flex total knee design used for TKA
Arm Title
Gender specific LPS-Flex
Arm Type
Experimental
Arm Description
Gender specific LPS flex design used for TKA in female patients
Intervention Type
Device
Intervention Name(s)
Standard LPS flex TKA
Other Intervention Name(s)
Standard Zimmer Nexgen Legacy posterior stabilized High-flex
Intervention Description
TKA by Standard LPS flex TKA
Intervention Type
Device
Intervention Name(s)
Gender specific LPS -Flex TKA
Other Intervention Name(s)
Gender specific Zimmer LPS High-flex
Intervention Description
Total knee design created specific for female patients
Primary Outcome Measure Information:
Title
knee function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
implant fit to patient
Time Frame
2 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoowang Choi, MD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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