A prospective, randomized, controlled trial of Mechanical Axis with Soft Tissue Release Balancing vs Functional Alignment with Bony Release Balancing in Total Knee Replacement – A study using Stryker Mako Robotic-Arm Assisted Technology®.

Stryker Australia Pty Ltd0 个研究点目标入组 278 人开始时间: 2020年1月9日最近更新: 2024年5月13日

适应症

试验速览

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•1. Patients are male or non-pregnant females requiring a primary total knee replacement for osteoarthritis and is indicated for robotic-assisted surgery
•2. The patient has intact collateral ligaments
•3. The patient is able to undergo CT scanning of the affected limb
•4. 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 previous osteotomy around the knee
•3. The patient is morbidly obese (BMI greater than 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 deformity equal to or greater than 15 degrees
•6. The patient has a fixed flexion deformity equal to or greater than 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

发起方