Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatments standard cutting guide for tka, otismed mri generated cutting guide for tka
Sponsor Phoenix VA Health Care System
Start date January 2008
End date July 2012
Trial size 120 participants
Trial identifier NCT00837772, Dossett01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Usual standard cutting guide for TKA (Total Knee Arthroscopy)
standard cutting guide for tka
Use of the usual cutting guide for surgical replacement of a diseased knee
(Experimental)
Otismed MRI generated cutting guide for TKA
otismed mri generated cutting guide for tka Otismed
Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Primary Outcomes

Measure
Patient scores on Oxford, Womac, and Knee Society scores
time frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.

Secondary Outcomes

Measure
Leg alignment based on Long Leg CT scans
time frame: Post-op

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

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.

Additional Information

Official title Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
Principal investigator Harold G. Dossett, MD MBA
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Phoenix VA Health Care System.