Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000513516
Ethics application status
Approved
Date submitted
30/04/2015
Date registered
22/05/2015
Date last updated
4/12/2020
Date data sharing statement initially provided
4/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
A prospective, randomised controlled trial evaluating clinical outcomes of patients undergoing 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
Secondary ID [1] 286619 0
None
Universal Trial Number (UTN)
U1111-1169-7520
Trial acronym
MAKORCT-15
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory degenerative joint disease in the knee 294936 0
Condition category
Condition code
Surgery 295191 295191 0 0
Surgical techniques
Musculoskeletal 295402 295402 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291753 0
Treatment: Devices
Intervention code [2] 291754 0
Treatment: Surgery
Comparator / control treatment
Patients randomised to this group will recieve a Triathlon Primary Total Knee implant. The Stryker Triathlon Primary Total Knee System is made up of various individual implants of different designs, sizes and thicknesses. The study devices include the;
* CR Femoral Cementless Component – Beaded with Peri-Apatite
* Primary Tibial Baseplate – Cemented
* CR Tibial Insert – X3
* CS Tibial Insert – X3
* Triathlon X3 Patella (cemented asymmetric/symmetric)

Stryker's robotic-arm assisted surgery system Mako will not be used for surgery on this group.

Duration of surgery is approximately 1.5hours

The follow up period for the study is 24 months.
Control group
Active

Outcomes
Primary outcome [1] 294944 0
To compare the clinical outcomes of Knee Replacement surgery using the Oxford Knee Score (OKS), in patients receiving Bicompartmental Knee Replacement performed using Restoris MCK Multicompartmental Knee System with 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.
Timepoint [1] 294944 0
Pre-operative, 6 weeks, 3 months, 12 months and 24 months post-operative.
Secondary outcome [1] 314430 0
To determine functional and clinical outcomes of Bicompartmental Knee Replacement (BKR) and Total Knee Replacement (TKR) (including pain, function and health-related quality of life) with Restoris MCK Multicompartmental Knee System and Triathlon Primary Total Knee System via the EQ-5D, Vas pain, Knee Society Score, Forgotten Joint Score

This is a composite secondary outcome
Timepoint [1] 314430 0
Pre-operative, 6 weeks, 3 months, 12 months and 24 months postoperatively
Secondary outcome [2] 314431 0
To compare incidence of loosening, reoperation and revision in patients receiving Restoris MCK Partial Knee implant, compared to Triathlon Total Knee System to be assessed by x-rays and adverse events.

This is a composite secondary outcome
Timepoint [2] 314431 0
immediate post operative, 6 weeks, 3 months, 12 months, 24 months postoperative
Secondary outcome [3] 314432 0
To determine length of hospital stay and rehabilitation program in patients receiving Restoris MCK Partial Knee implant, compared to Triathlon Total Knee System to be assessed by medical records and collected from patients at follow up visits.

This is a composite secondary outcome
Timepoint [3] 314432 0
immediate post operative, 6 weeks, 3 months, 12 months, 24 months postoperative

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/07/2015
Actual
12/08/2015
Date of last participant enrolment
Anticipated
Actual
21/08/2017
Date of last data collection
Anticipated
Actual
6/03/2019
Sample size
Target
70
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291187 0
Commercial sector/Industry
Name [1] 291187 0
Stryker Australia Pty Ltd.
Country [1] 291187 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd.
Address
8 Herbert Street, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 289865 0
None
Name [1] 289865 0
Address [1] 289865 0
Country [1] 289865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292759 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 292759 0
Level 3, St John of God House
177-179 Cambridge Street
Wembley WA 6014
Ethics committee country [1] 292759 0
Australia
Date submitted for ethics approval [1] 292759 0
04/05/2015
Approval date [1] 292759 0
18/06/2015
Ethics approval number [1] 292759 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56878 0
Mr Gavin Clark
Address 56878 0
Perth Hip & Knee
Suite 1/1 Wexford Street, Subiaco WA 6008
Country 56878 0
Australia
Phone 56878 0
+61 8 6489 1777
Fax 56878 0
Email 56878 0
Gavin@hipnknee.com.au
Contact person for public queries
Name 56879 0
Mrs Holly Solomon
Address 56879 0
Stryker
8 Herbert Street
St Leonards NSW 2065
Country 56879 0
Australia
Phone 56879 0
+61 2 9467 1072
Fax 56879 0
Email 56879 0
strykerclinicalresearch@stryker.com
Contact person for scientific queries
Name 56880 0
Mrs Holly Solomon
Address 56880 0
Stryker
8 Herbert Street
St Leonards NSW 2065
Country 56880 0
Australia
Phone 56880 0
+61 2 9467 1072
Fax 56880 0
Email 56880 0
strykerclinicalresearch@stryker.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Recruitment ceased early, sample size was not reached and thus the data cannot be analysed


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.