ACTRN12621000205831招募中未知
RASKAL: Robotic-assisted surgery and kinematic alignment in total knee arthroplasty. A registry-nested, multi-centre, 2 x 2 factorial randomised trial of clinical, functional, radiographic and survivorship outcomes
Australian Orthopaedic Association National Joint Replacement Registry0 个研究点目标入组 300 人开始时间: 2021年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 80 Years(—)
- 性别
- All
入选标准
- •1.All patients suitable for TKA age 40-80 years with a primary diagnosis of osteoarthritis.
- •2.Patients who meet the indications for primary unilateral TKA using the Stryker Triathlon cruciate-retaining TKA system.
排除标准
- •1.Knee flexion < 90 degrees and knee flexion contracture > 15 degrees at preoperative assessment
- •2.Coronal deformity with hip-knee-ankle (HKA) angle > 15 degrees varus and > 10 degrees valgus on standing long-leg radiographs
- •3.Prior grade 3 injury to posterior cruciate ligament, posterolateral corner, lateral collateral ligament or medial collateral ligament
- •4.TKA requiring increased prosthetic stability (posterior-stabilised, constrained condylar, or rotating hinge designs), diaphyseal stems or metal augments
- •5.TKA for causes other than osteoarthritis (inflammatory arthritis, post-traumatic arthritis, tumour or acute fracture)
- •6.Prior contralateral TKA within 6 months of current TKA surgery
- •7.Any prior knee surgery apart from arthroscopic surgery or anterior cruciate ligament reconstruction
- •8.Prior femoral, tibial or patellofemoral osteotomies
- •9.Symptomatic grade 3-4 ipsilateral ankle or hip arthritis
- •10.The participant unable to attend clinical follow-up for a minimum of 2 years
- •11.The participant is unable to provide informed consent (due to cognitive capacity or English proficiency)
研究者
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