Clinical trial NCT02650284: A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
Official title: A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Lead sponsor: Stryker South Pacific
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxford Knee Score
timeFrame: pre-op, 6 weeks, 3 months, 12 months, 24 months
Secondary outcomes:
measure: Health Related Quality of Life EQ-5D
timeFrame: 24 months/ 2years
measure: VAS Pain
timeFrame: 24 months/ 2years
measure: New Knee Society Score (KSS)
timeFrame: 24 months/ 2years
measure: Forgotten Joint Score (FJS)
timeFrame: 24 months/ 2years
measure: Incidence of Loosening, Reoperation and Revision
timeFrame: 6 weeks, 3 months, 12 months, 24 months
measure: Length of Hospital Stay
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: Perth Hip & Knee
state: Western Australia
Study officials:
affiliation: Perth Hip and Knee and St John of God Hospital
name: Gavin Clark, Dr
role: PRINCIPAL_INVESTIGATOR
References: