NCT00937170

Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Female
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-07-10
• Last updated: 2011-01-21