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

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ClinicalTrials.gov Identifier: NCT00837772
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Standard cutting guide for TKA Device: Otismed MRI generated cutting guide for TKA Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
Study Start Date : January 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
Usual standard cutting guide for TKA (Total Knee Arthroscopy)
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



Primary Outcome Measures :
  1. Patient scores on Oxford, Womac, and Knee Society scores [ Time Frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr. ]

Secondary Outcome Measures :
  1. Leg alignment based on Long Leg CT scans [ Time Frame: Post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Phoenix VA Health Care System
Investigators
Principal Investigator: Harold G. Dossett, MD MBA Carl T. Hayden VA Medical Center

Publications:
Responsible Party: Phoenix VA Health Care System
ClinicalTrials.gov Identifier: NCT00837772     History of Changes
Other Study ID Numbers: Dossett01
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Phoenix VA Health Care System:
Alignment

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases