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Trial registered on ANZCTR


Registration number
ACTRN12617000365369
Ethics application status
Approved
Date submitted
5/03/2017
Date registered
10/03/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, multicentre, clinical study using Robotic-Assisted Total Knee Replacement, Mako and the Triathlon Total Knee System
Scientific title
A prospective, multicentre, clinical study using Robotic-Assisted Total Knee Replacement, Mako and the Triathlon Total Knee System
Secondary ID [1] 291365 0
None
Universal Trial Number (UTN)
U1111-1193-8456
Trial acronym
MAKOTKR-17
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory degenerative joint disease in the knee 302349 0
Condition category
Condition code
Musculoskeletal 301934 301934 0 0
Osteoarthritis
Surgery 301935 301935 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients 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 following and will be used in combination based on the surgeon preference for the patient;
*Cruciate Retaining (CR) or Posterior Stabilizing (PS) Femoral Cementless Component – Beaded with Peri-Apatite
*CR or PS Femoral Cemented Component
*CR, CS or PS Primary Tibial Baseplate – Cemented
*CR, CS or PS Primary Tibial Baseplate – Cementless
*CR or PS Tibial Insert – X3
*Triathlon X3 Patella (cemented asymmetric/symmetric)

Stryker's robotic-arm assisted surgery system Mako will be used in surgery.

Duration of surgery is approximately 1.5hours and will be conducted by a qualified Orthopaedic surgeon at a hospital. Patient pre-operative and post-operative follow up visits will be conducted at the surgeons clinic rooms by a surgeon and a physiotherapist.

1 x pre-operative study visit will take place prior to surgery, and 3 x post-operative visits will take place at 3 months, 12 months and 24 months at the surgeons clinic. These visits will be conducted face to face with the surgeon and/or physiotherapist and should take less than 30 minutes in duration.
Intervention code [1] 297389 0
Treatment: Devices
Intervention code [2] 297390 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301358 0
To examine the clinical outcomes of Knee Replacement surgery using the Oxford Knee Score (OKS) at 24 months, in patients receiving Total Knee Replacement performed using Triathlon Total Knee System with Stryker’s robotic-arm assisted surgery system Mako.
Timepoint [1] 301358 0
24 months post-operative
Secondary outcome [1] 332415 0
To determine the functional and clinical outcomes of Total Knee Replacement (TKR) (including pain, function and health-related quality of life) with the Triathlon Primary Total Knee System at 24 months via EQ-5D
Timepoint [1] 332415 0
24 months post-operative
Secondary outcome [2] 332416 0
To determine patient satisfaction and frequency of recommendation via patient questionnaire designed for this study of the Triathlon Total Knee System using Stryker’s robotic-arm assisted surgery system Mako.
Timepoint [2] 332416 0
24 months post-operative
Secondary outcome [3] 332417 0
Composite, To determine the implant location and limb alignment within 3 months pre-operatively, intra-operatively, and 3 months post operatively via surgical data and radiology results.
Timepoint [3] 332417 0
3 months pre-operatively, intra-operatively and 3 months post operatively
Secondary outcome [4] 332418 0
Composite, To record the incidence of loosening, reoperation and revision in patients receiving the Triathlon Total Knee System using Stryker’s robotic-arm assisted surgery system Mako via radiology and adverse event data collected from the patient and medical records.
Timepoint [4] 332418 0
3 months, 12 months and 24 months post-operative
Secondary outcome [5] 332419 0
To determine the length of hospital stay in patients receiving the Triathlon Total Knee System using Stryker’s robotic-arm assisted surgery system Mako via review of medical records
Timepoint [5] 332419 0
3 months post-operative
Secondary outcome [6] 332552 0
To determine the functional and clinical outcomes of Total Knee Replacement (TKR) (including pain, function and health-related quality of life) with the Triathlon Primary Total Knee System at 24 months via Knee Society Score
Timepoint [6] 332552 0
24 months post-operative
Secondary outcome [7] 332553 0
To determine the functional and clinical outcomes of Total Knee Replacement (TKR) (including pain, function and health-related quality of life) with the Triathlon Primary Total Knee System at 24 months via Forgotten Joint Score.
Timepoint [7] 332553 0
24 months post-operative

Eligibility
Key inclusion criteria
1. The patient is a suitable candidate for a Primary Total Knee Replacement (based on the Investigator’s clinical judgement).
2. The patient is a male or non-pregnant female.
3. 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.
4. The patient is at least 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient is undergoing revision surgery
2. The patient has active, local infection or previous intra-articular infection
3. The patient has skeletal immaturity
4. The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
5. The patient has a blood supply limitation
6. The patient has collateral ligament insufficiency
7. The patient had a prior High Tibial Osteotomy (HTO)
8. The patient’s weight, age or activity level might cause extreme loads and early failure of the system (surgeon’s discretion).
9. 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.
10. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
17/04/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295836 0
Commercial sector/Industry
Name [1] 295836 0
Stryker Australia Pty Ltd.
Country [1] 295836 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] 294686 0
None
Name [1] 294686 0
Address [1] 294686 0
Country [1] 294686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297119 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 297119 0
Ethics committee country [1] 297119 0
Australia
Date submitted for ethics approval [1] 297119 0
07/03/2017
Approval date [1] 297119 0
12/04/2017
Ethics approval number [1] 297119 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73038 0
Mr Gavin Clark
Address 73038 0
Perth Hip and Knee
Suite 1/1 Wexford Street
Subiaco WA 6008
Country 73038 0
Australia
Phone 73038 0
+61 8 6489 1700
Fax 73038 0
Email 73038 0
[email protected]
Contact person for public queries
Name 73039 0
Holly Solomon
Address 73039 0
Stryker
8 Herbert Street
St Leonards NSW 2065
Country 73039 0
Australia
Phone 73039 0
+61 2 9467 1072
Fax 73039 0
Email 73039 0
[email protected]
Contact person for scientific queries
Name 73040 0
Holly Solomon
Address 73040 0
Stryker
8 Herbert Street
St Leonards NSW 2065
Country 73040 0
Australia
Phone 73040 0
+61 2 9467 1072
Fax 73040 0
Email 73040 0
[email protected]

No information has been provided regarding IPD availability


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.