Knee-Fix study : A prospective, randomised, controlled trial of cemented vs uncemented total knee replacement. A study comparing Stryker Triathlon TKR

orth Shore Hospital Waitemata DHB0 个研究点目标入组 316 人开始时间: 2016年11月24日最近更新: 2022年11月28日

适应症

试验速览

暂无简介。

•*The patient is a male or non-pregnant female between the ages of 40-75 years.
•*Patient is deemed appropriate for a cruciate retaining knee replacement.
•*The patient has a primary diagnosis of osteoarthritis (OA).
•*The patient has intact collateral ligaments.
•*The patient has signed the study specific, ethics-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 previous osteotomy around the knee.
•* The patient is morbidly obese (BMI greater than 41).
•* 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 a varus/valgus malalignment greater than 20 degrees (relative to mechanical axis).
•* The patient has a fixed flexion deformity greater than 20 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 or poor bone quality.
•* 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.
•* Patients NOT undergoing patellar resurfacing
•* The patient is pregnant.

发起方

orth Shore Hospital Waitemata DHB