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):
Phoenix VA Health Care System
ClinicalTrials.gov Identifier:
NCT00837772
First received: February 3, 2009
Last updated: March 25, 2015
Last verified: March 2015

February 3, 2009
March 25, 2015
January 2008
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00837772 on ClinicalTrials.gov Archive Site
Leg alignment based on Long Leg CT scans [ Time Frame: Post-op ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • 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
    Other Name: Otismed
  • Active Comparator: Arm 1
    Usual standard cutting guide for TKA (Total Knee Arthroscopy)
    Intervention: Device: Standard cutting guide for TKA
  • Experimental: Arm 2
    Otismed MRI generated cutting guide for TKA
    Intervention: Device: Otismed MRI generated cutting guide for TKA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
August 2015
July 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837772
Dossett01
No
Phoenix VA Health Care System
Phoenix VA Health Care System
Not Provided
Principal Investigator: Harold G. Dossett, MD MBA Carl T. Hayden VA Medical Center
Phoenix VA Health Care System
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP