A prospective randomized multi-centre study of the Triathlon Cruciate Retaining Total Knee System using ShapeMatched Cutting Guides

Stryker SA (Switzerland)0 个研究点目标入组 144 人开始时间: 2013年2月12日最近更新: 2016年12月19日

试验速览

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•1. Patient has signed an EC approved, study specific Informed Patient Consent Form
•2. Patient is a male or non-pregnant female, skeletally mature and age 18-80 years at the time of study device implantation
•3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
•4. Patient is a candidate for a primary total knee replacement
•5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

•1. Patient has a Body Mass Index (BMI) = 40
•2. Patient age = 80
•3. Patient has a varus or valgus deformity greater than 10° or flexion contracture greater than 20°
•4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
•5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year
•6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement
•7. Patient has any implanted device that would be incompatible with MRI procedures
•8. Patient has chronic heart failure (NYHA Stage = 2)
•9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
•10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget?s disease) leading to progressive bone deterioration
•11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
•12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint
•13. Patient has a known sensitivity to device materials
•14. Patient is a prisoner

发起方

Stryker SA (Switzerland)