Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide

Study Overview
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Brief Summary
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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
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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: 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.

Official Title
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Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Standard cutting guide for TKA
* Device: Otismed MRI generated cutting guide for TKA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Usual standard cutting guide for TKA (Total Knee Arthroscopy) | Device: Standard cutting guide for TKA<br>* Use of the usual cutting guide for surgical replacement of a diseased knee<br>|
| Experimental: Arm 2<br>Otismed MRI generated cutting guide for TKA | Device: Otismed MRI generated cutting guide for TKA<br>* Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee<br>* Other names: Otismed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient scores on Oxford, Womac, and Knee Society scores |  | 4 week, 3 mo. 6 mo. 1 yr. 2 yr. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg alignment based on Long Leg CT scans |  | Post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alignment