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

NCT02650284 | Terminated Results

• 1 other identifier: MAKORCT-15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-inflammatory Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health Related Quality of Life EQ-5D

  24 months/ 2years

• VAS Pain

  24 months/ 2years

• New Knee Society Score (KSS)

  24 months/ 2years

• Forgotten Joint Score (FJS)

  24 months/ 2years

• Incidence of Loosening, Reoperation and Revision

  6 weeks, 3 months, 12 months, 24 months

Study Arms (2)

Bicompartmental Knee Replacement (BKR)

OTHER

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

Total Knee Replacement (TKR)

OTHER

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

Interventions

Stryker Triathlon Primary Total Knee System DEVICE

Total Knee Replacement

Total Knee Replacement (TKR)

Restoris MCK Multicompartmental Knee System DEVICE

Bicompartmental Knee Replacement

Bicompartmental Knee Replacement (BKR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
• The patient has no fixed flexion greater than 10 degrees.
• The patient has maximal flexion greater than 100 degrees
• The patient has a passively correctable varus deformity
• The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
• The patient has no significant patellofemoral malalignment
• The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
• The patient has pain that is not localised to the medial compartment only
• The patient is a male or non-pregnant female.
• 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

You may not qualify if:

• The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
• The patient is undergoing revision surgery
• The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
• The patient has active, local infection or previous intra-articular infection
• The patient has skeletal immaturity
• The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
• The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
• 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.
• 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
• Patients with tricompartmental disease are contraindicated from the study

Sponsors & Collaborators

• Stryker South Pacific: lead

Study Sites (1)

Perth Hip & Knee

Subiaco, Western Australia, 6008, Australia

Location

Limitations and Caveats

There existed complexities in recruiting patients that complied with the inclusion and exclusion criteria of the study. The randomised nature of this study required detailed criteria, yet it was difficult in recruiting patients suitable for both bicompartmental and total knee replacement surgeries.

Results Point of Contact

• Title: Alissa Connelly
• Organization: Stryker

alissa.connelly@stryker.com

+61294671000

Study Officials

• Gavin Clark, Dr

  Perth Hip and Knee and St John of God Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: August 12, 2015
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: June 29, 2022
• Results First Posted: June 4, 2021

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)