Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

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.
    

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.
    

Intervention name(s): Standard cutting guide for TKA; Otismed MRI generated cutting guide for TKA
Intervention type(s): Device; Device
Intervention description(s): Use of the usual cutting guide for surgical replacement of a diseased knee; Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee
Other intervention name(s): Otismed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alignment