Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Not Applicable

Withdrawn

• Conditions: Knee Osteoarthritis

• Registration Number: NCT00937170
• Lead Sponsor: UConn Health

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 available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evidence of improved pain relief and function	Pre-op, 4 weeks, 4 months, 1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
Evidence of improved patellofemoral biomechanics	Pre-op, 4 months, 1 year