Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

January 20, 2011 updated by: UConn Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gender Specific LPS flex
Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design
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
ACTIVE_COMPARATOR: LPS flex
Participants in this arm will receive the Zimmer High Flex LPS implant
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
ACTIVE_COMPARATOR: Triathlon
Participants in this arm will receive the Stryker Triathlon Implant design
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of improved pain relief and function
Time Frame: Pre-op, 4 weeks, 4 months, 1 year, 2 years
Pre-op, 4 weeks, 4 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of improved patellofemoral biomechanics
Time Frame: Pre-op, 4 months, 1 year
Pre-op, 4 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Stryker Orthopaedics

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (ESTIMATE)

July 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-036C-2
  • RMM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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