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

April 4, 2016 updated by: Phoenix VA Health Care System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Otismed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix VA Health Care System

Investigators

  • Principal Investigator: Harold G. Dossett, MD MBA, Carl T. Hayden VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (ESTIMATE)

February 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dossett01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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