Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

This study has been withdrawn prior to enrollment.

Sponsor:

Collaborator:

Stryker Orthopaedics

Information provided by:

University of Connecticut Health Center

ClinicalTrials.gov Identifier:

NCT00937170

First received: July 9, 2009

Last updated: January 20, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 9, 2009

Last Updated Date

January 20, 2011

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evidence of improved pain relief and function [ Time Frame: Pre-op, 4 weeks, 4 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00937170 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evidence of improved patellofemoral biomechanics [ Time Frame: Pre-op, 4 months, 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Official Title ^ICMJE

A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs

Brief Summary

The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Knee Osteoarthritis

Intervention ^ICMJE

Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Device: Zimmer High Flex LPS Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Device: Stryker Triathlon Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company

Study Arm (s)

Experimental: Gender Specific LPS flex
Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design

Intervention: Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)
Active Comparator: LPS flex
Participants in this arm will receive the Zimmer High Flex LPS implant

Intervention: Device: Zimmer High Flex LPS Implant (Total knee replacement)
Active Comparator: Triathlon
Participants in this arm will receive the Stryker Triathlon Implant design

Intervention: Device: Stryker Triathlon Implant (Total knee replacement)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

clinical diagnosis of end-stage degenerative joint disease of the knee
must be deemed appropriate for total knee replacement surgery

Exclusion Criteria:

severe flexion deformity of the knee
greater than 20deg varus or valgus malalignment
osteomyelitis, septicemia, prior infection of the knee joint
presence of infections or highly communicable diseases
significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
metastatic disease
congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
previous total knee replacement in affected knee
arthrodesis of the affected knee

Gender

Female

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00937170

Other Study ID Numbers ^ICMJE

09-036C-2, RMM001

Has Data Monitoring Committee

Responsible Party

R. Michael Meneghini, M.D., University of Connecticut Health Center Department of Orthopaedics

Study Sponsor ^ICMJE

University of Connecticut Health Center

Collaborators ^ICMJE

Stryker Orthopaedics

Investigators ^ICMJE

Principal Investigator:

R. Michael Meneghini, M.D.

University of Connecticut Health Center, Farmington CT, United States

Information Provided By

University of Connecticut Health Center

Verification Date

January 2011

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

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