Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Patient scores on Oxford, Womac, and Knee Society scores
Study Overview
Brief Summary
Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.
Detailed Description
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:
- surgical procedure with the standard knee cutting guide and
- surgical procedure with the Otismed MRI generated cutting guide
Secondary:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.
Exclusion Criteria
- •Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
Arms & Interventions
Arm 2
Otismed MRI generated cutting guide for TKA
Intervention: Otismed MRI generated cutting guide for TKA (Device)
Arm 1
Usual standard cutting guide for TKA (Total Knee Arthroscopy)
Intervention: Standard cutting guide for TKA (Device)
Outcomes
Primary Outcomes
Patient scores on Oxford, Womac, and Knee Society scores
Time Frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.
Secondary Outcomes
- Leg alignment based on Long Leg CT scans(Post-op)