Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

NCT ID: NCT00937170

Last Updated: 2011-01-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gender Specific LPS flex

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

Group Type: EXPERIMENTAL

Zimmer LPS flex Gender Specific Implant (Total knee replacement)

Intervention Type: DEVICE

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

LPS flex

Participants in this arm will receive the Zimmer High Flex LPS implant

Group Type: ACTIVE_COMPARATOR

Zimmer High Flex LPS Implant (Total knee replacement)

Intervention Type: DEVICE

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

Triathlon

Participants in this arm will receive the Stryker Triathlon Implant design

Group Type: ACTIVE_COMPARATOR

Stryker Triathlon Implant (Total knee replacement)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

University of Connecticut Health Center Department of Orthopaedics

Principal Investigators

R. Michael Meneghini, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut Health Center, Farmington CT, United States

Other Identifiers

RMM001

Identifier Type: -

Identifier Source: secondary_id

09-036C-2

Identifier Type: -

Identifier Source: org_study_id