None listed
Conditions
Brief summary
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker’s robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study. The study will be conducted in patients with non-inflammatory degenerative joint disease who are randomised to either the Restoris'Registered TradeMark' MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR), or the Triathlon Total Knee System for Total Knee Replacement (TKR), with a minimum 2 year patient evaluation period.
Interventions
Patients randomised to this group will recieve a Restoris MCK Mulitcompartmental Knee implant.
The components of the RESTORIS 'Registered Trademark' MCK system are used to individually treat the components of the knee when showing osteoarthritis. The medial unicondylar and patellofemoral components may be combined to perform a bicompartmental knee arthroplasty.
The robotic-arm assisted system utilizes tactile robotic arm technology with integrated intelligent surgical instruments and navigat
Patients randomised to this group will recieve a Restoris MCK Mulitcompartmental Knee implant. The components of the RESTORIS 'Registered Trademark' MCK system are used to individually treat the components of the knee when showing osteoarthritis. The medial unicondylar and patellofemoral components may be combined to perform a bicompartmental knee arthroplasty. The robotic-arm assisted system utilizes tactile robotic arm technology with integrated intelligent surgical instruments and navigation visualization system to pre-plan and treat each patient uniquely. The end effector of the robotic arm is controlled by the surgeon as shown while the system provides the surgeon with real-time visual, tactile and auditory feedback. Duration of surgery is approximately 1.5hours The follow up period for the study is 24 months.
Sponsors
Stryker Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Outcome results
None listed