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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

NCT02527148

Arthroplasties Knee Replacement

COMPLETED NA

A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides

NCT01072019

Osteoarthritis of the Knee

COMPLETED NA

Total Knee Arthroplasty Guidance Systems Study

NCT02830997

Osteoarthritis, Knee Arthroplasty, Replacement, Knee

COMPLETED

Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

NCT01084772

Degenerative Arthritis of Knee

TERMINATED NA

Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements

NCT03088748

Arthroplasty, Replacement, Knee Osteoarthritis, Knee

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Usual standard cutting guide for TKA (Total Knee Arthroscopy)

Group Type ACTIVE_COMPARATOR

Standard cutting guide for TKA

Intervention Type DEVICE

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

Arm 2

Otismed MRI generated cutting guide for TKA

Group Type EXPERIMENTAL

Otismed MRI generated cutting guide for TKA

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard cutting guide for TKA

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

Intervention Type DEVICE

Otismed MRI generated cutting guide for TKA

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Otismed

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes