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 sites300 target enrollmentFebruary 26, 2021

Overview

Phase: 未知
Intervention: Not specified
Conditions: End Stage Arthritis
Sponsor: Australian Orthopaedic Association National Joint Replacement Registry
Enrollment: 300
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 26, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Australian Orthopaedic Association National Joint Replacement Registry

•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.

•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