A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot

Stryker

Status: Terminated

Conditions: Non-inflammatory Degenerative Joint Disease

Treatments: Device: Stryker Triathlon Primary Total Knee System; Device: Restoris MCK Multicompartmental Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02650284

MAKORCT-15

Details and patient eligibility

About

A prospective, randomised controlled trial evaluating 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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Anterior Cruciate Ligament (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, Human Research Ethics Committee (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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups

Bicompartmental Knee Replacement (BKR)

Other group

Description:

Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako

Treatment:

Device: Restoris MCK Multicompartmental Knee System

Total Knee Replacement (TKR)

Other group

Description:

Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako

Treatment:

Device: Stryker Triathlon Primary Total Knee System