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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00837772

First received: February 3, 2009

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Purpose

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.

Condition	Intervention
Arthroplasty, Replacement, Knee	Device: Standard cutting guide for TKA Device: Otismed MRI generated cutting guide for TKA

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

patient scores on Oxford, Womac, and Knee Society scores [ Time Frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Leg alignment based on Long Leg CT scans [ Time Frame: Post-op ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2013
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 Usual standard cutting guide for TKA	Device: Standard cutting guide for TKA Use of the usual cutting guide for surgical replacement of a diseased knee
Experimental: Arm 2 Otismed MRI generated cutting guide for TKA	Device: Otismed MRI generated cutting guide for TKA Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee Other Name: Otismed

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:

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 Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM 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.

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837772

Locations

United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Harold G. Dossett, MD MBA

Carl T. Hayden VA Medical Center

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00837772 History of Changes
Other Study ID Numbers:	Dossett01
Study First Received:	February 3, 2009
Last Updated:	December 20, 2012
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

alignment

ClinicalTrials.gov processed this record on May 16, 2013

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