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 个研究点目标入组 100 人开始时间: 2011年2月8日最近更新: 2020年1月13日

适应症

试验速览

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•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.
•-The patient is pregnant.
•-The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
•-The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).

发起方

Stryker Australia