Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Device: Standard cutting guide for TKADevice: Otismed MRI generated cutting guide for TKA
- Registration Number
- NCT00837772
- Lead Sponsor
- Phoenix VA Health Care System
- 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:
1. surgical procedure with the standard knee cutting guide and
2. surgical procedure with the Otismed MRI generated cutting guide
Secondary:
Evaluate the cost benefit ratio related to the two different cutting guide uses.
Research Plan: All patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. Patients will be randomly assigned to either the standard or the Otismed group. All patients will have a MRI of the knee. Patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery.
Methods: The study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. The study will be conducted at one site and enrollment goal is 100 patients. Data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. Established instruments, the (Western Ontario and McMaster Universities Osteoarthritis Index) Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM (Range Of Motion) and assess post-op recovery. Surgical data and hospitalization data will be used for analysis of costs. Statistical analysis will be used for comparison of the two groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Standard cutting guide for TKA Usual standard cutting guide for TKA (Total Knee Arthroscopy) Arm 2 Otismed MRI generated cutting guide for TKA Otismed MRI generated cutting guide for TKA
- Primary Outcome Measures
Name Time Method Patient scores on Oxford, Womac, and Knee Society scores 4 week, 3 mo. 6 mo. 1 yr. 2 yr.
- Secondary Outcome Measures
Name Time Method Leg alignment based on Long Leg CT scans Post-op
Trial Locations
- Locations (2)
Carl T. Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
🇺🇸Salt Lake City, Utah, United States