A prospective, randomised controlled trial evaluating clinical outcomes of patients undergoing Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker’s Robotic-arm assisted surgery system, Mako

Stryker Australia Pty Ltd.0 sites18 target enrollmentMay 22, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 22, 2015

End Date

March 6, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
•2\.The patient has no fixed flexion greater than 10 degrees.
•3\.The patient has maximal flexion greater than 100 degrees
•4\.The patient has a passively correctable varus deformity
•5\.The patient has a functionally Intact ACL.
•6\.The patient has no significant patellofemoral malalignment
•7\.The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon’s discretion).
•8\.The patient has pain that is not localised to the medial compartment only
•9\.The patient is a male or non\-pregnant female.
•10\.The patient has signed the study specific, HREC\-approved, Informed Consent document and is willing and able to comply with the specified pre\-operative and post\-operative clinical and radiographic evaluations.

•1\.The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on MRI or MRI/CT Arthrogram
•2\.The patient is undergoing revision surgery
•3\.The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
•4\.The patient has active, local infection or previous intra\-articular infection
•5\.The patient has skeletal immaturity
•6\.The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
•7\.The patient’s weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
•8\.The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
•9\.Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient’s capacity to consent to research and the ability to participate in it
•10\.Patients with tricompartmental disease are contraindicated from the study