In patients with osteoarthritis of the knee, are patient specific cutting guides used for total knee joint replacement as good as computer-assisted surgery for patient outcomes?

Stryker Australia0 sites100 target enrollmentFebruary 8, 2011

Overview

No summary available.

Registry

who.int

Start Date

February 8, 2011

End Date

April 9, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Stryker Australia

•The patient is a male or non\-pregnant female between the ages of 50\-80\.
•\-The patient requires a primary total knee replacement and is indicated for computer\-assisted surgery.
•\-The patient has a primary diagnosis of osteoarthritis (OA).
•\-The patient has intact collateral ligaments.
•\-The patient is able to undergo MRI scanning of the affected limb.
•\-The patient has signed the study specific, HREC\-approved, Informed Consent document.
•\-The patient is willing and able to comply with the specified pre\-operative and post\-operative clinical and radiographic evaluations.

•\-The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
•\-Patient has had a high tibial osteotomy or femoral osteotomy.
•\-The patient is morbidly obese (BMI is greater than or equal to 40\).
•\-The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
•\-The patient has varus or valgus malalignment greater than or equal to 15 degrees (relative to mechanical axis).
•\-The patient has a fixed flexion deformity greater than or equal to 15 degrees.
•\-The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•\-The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
•\-The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
•\-Patient has a cognitive impairment, an intellectual disability or a mental illness.