NCT00837772

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Phoenix VA Health Care System · Federal
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Standard cutting guide for TKA	Use of the usual cutting guide for surgical replacement of a diseased knee
DEVICE	Otismed MRI generated cutting guide for TKA	Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-07-01
• Completion: 2014-07-01
• First posted: 2009-02-05
• Last updated: 2016-04-06

Locations

2 sites across 1 country: United States