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Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

NCT00937170 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2011-01-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • UConn Health

    lead OTHER

Principal Investigators

  • R. Michael Meneghini, M.D. · University of Connecticut Health Center, Farmington CT, United States

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937170 on ClinicalTrials.gov