Skip to main content
OpenTrials
Completed

NCT Number: NCT00837772

Total Knee Replacement Study Using Standard Cutting Guide 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carl T. Hayden VA Medical Center, Phoenix, Arizona, United States

Loading trial locations.

About this study

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 (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard cutting guide for TKA

Device

Use of the usual cutting guide for surgical replacement of a diseased knee

Otismed MRI generated cutting guide for TKA

Device

Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Other names: Otismed

Primary outcomes

  1. Patient scores on Oxford, Womac, and Knee Society scores

    Time frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.

Secondary outcomes

  1. Leg alignment based on Long Leg CT scans

    Time frame: Post-op

Sponsors and collaborators

Lead sponsor

Phoenix VA Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Feb 5, 2009
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.