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Trial registered on ANZCTR


Registration number
ACTRN12616001594415
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
18/11/2016
Date last updated
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
MAKO RAPTOR study-Efficacy of robot assisted partial knee replacement versus navigated total knee replacement.
Scientific title
MAKO RAPTOR study-A prospective, randomized, controlled trial of Robot
Unicompartmental Knee Replacement vs. Navigated Total Knee Replacement – A
study comparing Stryker PrecisioN Knee Navigation and Stryker MAKO Robotic Technology.
Secondary ID [1] 289294 0
none
Universal Trial Number (UTN)
Trial acronym
MAKO RAPTOR study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 298879 0
Condition category
Condition code
Surgery 298954 298954 0 0
Surgical techniques
Musculoskeletal 298975 298975 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with medial compartment osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker MAKO Unicompartmental Knee Replacement (UKR) using Robotic surgery (intervention) or
the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control).

The Stryker MAKO UKR replaces the medial knee joint, using robot assistance for accurate cuts than if performed manually by a surgeon. The technique adds approximately 10 minutes to the procedure therefore the total time of the operation will be approximately 90 minutes. With better positioning of the implant, better outcomes are expected. The operations will be performed by consultant orthopaedic surgeons.
Intervention code [1] 294844 0
Treatment: Surgery
Intervention code [2] 294863 0
Treatment: Devices
Comparator / control treatment
The comparator treatment is the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control). The navigation technique adds approximately 10 minutes to the procedure therefore the total time of the operation will be approximately 90 minutes. It involves the use of bony landmarks and computer navigation trackers to more accurately work out alignment of bony cuts aiding better positioning of the implant over not using it. The operations will be performed by consultant orthopaedic surgeons.
Control group
Active

Outcomes
Primary outcome [1] 298426 0
Knee function, assessed using the Oxford Knee Score.
Timepoint [1] 298426 0
6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years post surgery
Secondary outcome [1] 324093 0
Participants will complete measures of quality of life using EQ 5D
Timepoint [1] 324093 0
24 months, 5 years and 10 years post surgery
Secondary outcome [2] 324159 0
Participants will complete measures of VAS pain
Timepoint [2] 324159 0
6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years post surgery
Secondary outcome [3] 324160 0
Participants will complete measures of functional outcome using Get Up and Go Test
Timepoint [3] 324160 0
6 weeks, 6 months and 12 months post surgery
Secondary outcome [4] 324163 0
Participants will have radiological assessment of the knee through AP and Lateral X-rays.
Timepoint [4] 324163 0
6 months, 12 months, 24 months, 5 years and 10 years post surgery
Secondary outcome [5] 324561 0
Patients will have Patient reported outcome measures questionnaire assessment including UCLA activity score
Timepoint [5] 324561 0
6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years post surgery
Secondary outcome [6] 329453 0
Patients will have Patient reported outcome measures questionnaire assessment including UCLA activity score
Timepoint [6] 329453 0
6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years post surgery

Eligibility
Key inclusion criteria
The patient is a male or female over the age of 45 years.
The patient has signed the study specific, ethics-approved, informed consent document.
The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Patient is deemed appropriate for a UKR knee replacement by the following parameters.
The patient has a primary diagnosis of osteoarthritis (OA) of the medial compartment with exposed bone on both the tibia and femur .
The patient has a functioning ACL ligament.
Full thickness and good quality lateral cartilage present
Correctable varus deformity of the knee
Minimum age
45 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intra-operative findings of significant damage to the patella-femoral joint, especially of the lateral facet
The patient is morbidly obese with BMI greater than 40.
The patient has significant virus or valgus deformity more than 15 degrees
The patient has a fixed flexion deformity more than 15 degrees.
The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
Patient has previously had septic arthritis of the knee
Patient has had previous surgery to the same knee such as ligament reconstruction, any form of joint replacement, or osteotomy around the knee.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Justification
The New Zealand National Joint Registry reported a mean Oxford Knee Score of
37.05 (with a standard deviation of 8.30) at 6 months following total knee arthroplasty, using mostly conventional instruments (NZOA New Zealand Joint Registry, 2014).

Beard et al. (2015) undertook a study comparing the clinical outcomes of Total Knee Replacement. They have determined that a clinically meaningful change in Clinical trials is a 5-point change in Oxford Knee Scores. The distribution based minimal detectable change (MDC 90) was 4 points.

The power calculation has shown that to detect a 4 point change a minimum of 60 patients per group are required, based on an improvement of the Oxford Knee Score of 4 points, with 80% power, a standard deviation of 8.0 and a significance level of 5%. We have added an extra 10 patients to account for dropout, particularly from the UKA group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7899 0
New Zealand
State/province [1] 7899 0
auckland

Funding & Sponsors
Funding source category [1] 293673 0
Charities/Societies/Foundations
Name [1] 293673 0
Orthopaedic Education and Research Fund- Three Harbours Health Foundation
Address [1] 293673 0
Orthopaedic Education and Research Fund
Three Harbours Health Foundation
Private Bag 93-503
Takapuna
Auckland 0622
NZ
Country [1] 293673 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital-Waitemata DHB
Address
North Shore Hospital
124 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292505 0
None
Name [1] 292505 0
none
Address [1] 292505 0
none
Country [1] 292505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295110 0
Northern B-Health and Disability Ethics Committee
Ethics committee address [1] 295110 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6140
NZ
Ethics committee country [1] 295110 0
New Zealand
Date submitted for ethics approval [1] 295110 0
04/09/2016
Approval date [1] 295110 0
04/11/2016
Ethics approval number [1] 295110 0
16/NTB/120

Summary
Brief summary
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with medial compartment osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker MAKO Unicompartmental Knee Replacement (UKR) using Robotic surgery (intervention) or
the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control).
When compared to TKA, UKR knees have fewer complications, shorter hospital stay, better patient satisfaction, and a faster return to work. The downside to UKA is a higher revision rate when compared to TKA, particularly if components are implanted incorrectly. UKA surgery is more technically demanding than TKA, and errors in component positioning or ligament balancing can contribute to early failure.
Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each followup interval. An economics analysis will also be conducted to compare costs associated with each technology platform.
A maximum of 65 cases will be enrolled in each group, for a total of 130 patients. It is expected that participants will be recruited over a 24 month period. Initial data analysis will occur at two year follow up, thus the total duration of the initial phase of the study is expected to be 4 years. Further follow up to monitor implant durability will continue for 10
years.
All participants (control and intervention groups) will be requested to attend visits preoperatively and postoperatively at 6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years. At these visits participants will complete assessments relating to quality of life, pain and functional outcome.
Participants will have standard knee Xrays taken preoperatively and postoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66158 0
Mr Simon Young
Address 66158 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 66158 0
New Zealand
Phone 66158 0
+64 94868900
Fax 66158 0
Email 66158 0
simon.young@auckland.ac.nz
Contact person for public queries
Name 66159 0
Mr Luke Brunton
Address 66159 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 66159 0
New Zealand
Phone 66159 0
+64 94868900
Fax 66159 0
Email 66159 0
luke.brunton@waitematadhb.govt.nz
Contact person for scientific queries
Name 66160 0
Mr Luke Brunton
Address 66160 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Country 66160 0
New Zealand
Phone 66160 0
+64 94868900
Fax 66160 0
Email 66160 0
luke.brunton@waitematadhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results