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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
 Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)
Device: Zimmer High Flex LPS Implant (Total knee replacement)
Device: Stryker Triathlon Implant (Total knee replacement)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

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

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

Enrollment: 0
Study Start Date: June 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937170

Sponsors and Collaborators
University of Connecticut Health Center
Stryker Orthopaedics
Investigators
Principal Investigator: R. Michael Meneghini, M.D. University of Connecticut Health Center, Farmington CT, United States
  More Information

No publications provided

Responsible Party: R. Michael Meneghini, M.D., University of Connecticut Health Center Department of Orthopaedics
ClinicalTrials.gov Identifier: NCT00937170     History of Changes
Other Study ID Numbers: 09-036C-2, RMM001
Study First Received: July 9, 2009
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Total Knee Replacement
Gender Specific Design

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013