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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non-inflammatory Degenerative Joint Disease
• Intervention / Treatment: Device: Restoris MCK Multicompartmental Knee System; Device: Stryker Triathlon Primary Total Knee System

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Perth Hip & Knee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bicompartmental Knee Replacement (BKR); Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako	Device: Restoris MCK Multicompartmental Knee System; Bicompartmental Knee Replacement
Other: Total Knee Replacement (TKR); Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako	Device: Stryker Triathlon Primary Total Knee System; Total Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.	pre-op, 6 weeks, 3 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life EQ-5D	Comparing functional and clinical outcomes using the EQ-5D. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. Index values range from 0-1, with 1 being representing "full health". The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. The VAS scales represents health on the day.	24 months/ 2years
VAS Pain	Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain.	24 months/ 2years
New Knee Society Score (KSS)	Comparing functional and clinical outcomes using the KSS. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	24 months/ 2years
Forgotten Joint Score (FJS)	Comparing functional and clinical outcomes using the FJS. The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).	24 months/ 2years
Incidence of Loosening, Reoperation and Revision	To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports.	6 weeks, 3 months, 12 months, 24 months
Length of Hospital Stay	To compare length of hospital stay between the two arms of the study	6 weeks

Collaborators and Investigators

• Sponsor: Stryker South Pacific
• Investigators: Principal Investigator: Gavin Clark, Dr, Perth Hip and Knee and St John of God Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2015
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: MAKORCT-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No