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临床试验/ACTRN12621000205831
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

发起方
Australian Orthopaedic Association National Joint Replacement Registry

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