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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837772
• Other study ID #: Dossett01
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: April 4, 2016
• Start date: January 2008
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: Phoenix VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Standard cutting guide for TKA
Use of the usual cutting guide for surgical replacement of a diseased knee
• Otismed MRI generated cutting guide for TKA
Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Locations

Country	Name	City	State
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix VA Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient scores on Oxford, Womac, and Knee Society scores		4 week, 3 mo. 6 mo. 1 yr. 2 yr.	No
Secondary	Leg alignment based on Long Leg CT scans		Post-op	No