ISRCTN44765636
已完成
不适用
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2013年2月12日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Stryker SA (Switzerland)
- 入组人数
- 144
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
相似试验
已完成
不适用
A prospective study to assess the diagnostic accuracy and management impact of Prostate Specific Membrane Antigen (PSMA) PET scanning in men with prostate cancer being considered for surgery or radiotherapy.Prostate cancerCancer - ProstateACTRN12617000005358Peter MacCallum Cancer Centre302
已完成
不适用
A multicenter, randomized controlled study of the clinical efficacy of intravenous peramivir versus oseltamivir against influenza A and B virus infection in high-risk patientsInfluenza virus infectionJPRN-UMIN000009479agasaki evaluation organization for clinical interventions120
已完成
不适用
A prospective multicenter study for evaluation of the accuracy and clinical usefulness of the high-sensitivity next-generation sequencing panel using cytological specimens from lung cancerlung cancerJPRN-UMIN000047215St. Marianna University School of Medicine260
进行中（未招募）
1 期
A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer alone for the treatment of dermatophytic onychomycosis (toenail) without matrix involvement - ONICOEUCTR2009-011125-14-FRPierre Fabre Dermatologie260
招募中
不适用
Prospective multicenter observational study of an integrated Artificial Intelligence system with live monitoringC50D05Malignant neoplasm of breastCarcinoma in situ of breastDRKS00027322Vara (MX Healthcare GmbH)400,000