In patients with osteoarthritis of the knee, are patient specific cutting guides used for total knee joint replacement as good as traditional instruments for patient outcomes?

Stryker Australia0 sites100 target enrollmentMarch 3, 2010

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2010

End Date

April 19, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Stryker Australia

•1\. The patient is a male or non\-pregnant female between the ages of 50\-90\.
•2\. The patient requires a primary total knee replacement and is indicated for computer\-assisted surgery.
•3\. The patient has a primary diagnosis of osteoarthritis (OA).
•4\. The patient has intact collateral ligaments.
•5\. The patient is able to undergo MRI scanning of the affected limb.
•6\. The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Informed Consent document.
•7\. The patient is willing and able to comply with the specified pre\-operative and post\-operative clinical and radiographic evaluations.

•1\. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
•2\. Patient has had a high tibial osteotomy or femoral osteotomy.
•3\. The patient is morbidly obese (Body Mass Index, BMI \= 40\).
•4\. The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
•5\. The patient has a varus/valgus malalignment \= 15 degrees.
•6\. The patient has a fixed flexion deformity \= 15 degrees.
•7\. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•8\. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
•9\. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
•10\. Patient has a cognitive impairment, an intellectual disability or a mental illness.