iTotal Pilot Study of ConforMIS Custom Total Knee Implant
- Conditions
- Knee Arthroplasty, Total
- Interventions
- Device: ConforMIS custom total knee
- Registration Number
- NCT02186587
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant.
Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).
- Detailed Description
The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- undergoing total knee arthroplasty
- BMI >40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ConforMIS ConforMIS custom total knee Subjects who receive a ConforMIS custom total knee implant.
- Primary Outcome Measures
Name Time Method Distance Measured During 6-minute Walk Test 6 months Subjects will walk for 6 minutes and the distance covered will be measured in feet.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Missouri Orthopaedic Institute
🇺🇸Columbia, Missouri, United States