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 个研究点目标入组 100 人开始时间: 2010年3月3日最近更新: 2020年1月13日

适应症

试验速览

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•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.
•11. The patient is pregnant.
•12. The patient has no metal hardware present in the region of the hip, knee or ankle
•13. The patient has any known contraindications for undergoing assessment by MRI

发起方

Stryker Australia