Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000370707p
Ethics application status
Submitted, not yet approved
Date submitted
8/02/2022
Date registered
2/03/2022
Date last updated
2/03/2022
Date data sharing statement initially provided
2/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The enrolment of Total Hip (THA), Total Knee (TKA) or Partial Knee Arthroplasty (PKA) patients performed using either Stryker Mako Robotic-Arm Assisted Technology (Mako) or non-Mako techniques into an outcomes data registry.
Scientific title
The enrolment of Total Hip (THA), Total Knee (TKA) or Partial Knee Arthroplasty (PKA) patients performed using either Stryker Mako Robotic-Arm Assisted Technology (Mako) or non-Mako techniques into an outcomes data registry.
Secondary ID [1] 306230 0
None
Universal Trial Number (UTN)
Trial acronym
myrecovery Data Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 324952 0
Partial Knee Arthroplasty 324953 0
Total Hip Arthroplasty 324954 0
Condition category
Condition code
Musculoskeletal 322382 322382 0 0
Osteoarthritis
Surgery 322383 322383 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Either total knee, partial knee or total hip arthroplasty operated with the Stryker Mako Robotic-Arm Assisted Technology. No specific intervention (i.e. implant choice) is prescribed. Surgeons are to follow their usual stand of care pathway and collect outcome data on patients. Such data consists of patient questionnaires and objective activity level data only and is to be collected via an electronic platform, called myrecovery. Myrecovery is an app that collects health outcomes. In the clinic when patients are invited to the registry the surgeon will provide information on how to download the myrecovery app. Questionnaires are then made available at specific timepoints for patients to complete. In addition to these questionnaires, participants may opt-in to schedule exercise. As such, interaction with the app will vary between patients and no set frequency/length of app interaction is prescribed. Participant adherence to the app will not be monitored throughout the study but will instead be analysed at the time of data analysis by accessing data exported from the myrecovery app. This app platform does not alter treatment plan. The joint arthroplasty procedures included in this registry will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.
Intervention code [1] 322651 0
Treatment: Surgery
Intervention code [2] 322652 0
Treatment: Devices
Comparator / control treatment
non-Mako
Control group
Active

Outcomes
Primary outcome [1] 330175 0
To compare the restoration of "normal feeling" of patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Forgotten Joint Score.
Timepoint [1] 330175 0
Post-operative: 6 weeks, 1 year (primary timepoint), 2 years
Primary outcome [2] 330370 0
To compare the postoperative satisfaction of patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Net Promoter.
Timepoint [2] 330370 0
Post-operative: 6 months
Primary outcome [3] 330371 0
To compare the postoperative satisfaction of patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question on how satisfied they are with their procedure. This questionnaire was designed specifically for this study.
Timepoint [3] 330371 0
Post-operative: 6 months, 1 year (primary timepoint), 2 years
Secondary outcome [1] 405135 0
To compare the health related quality of life of patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, EQ-5D-5L
Timepoint [1] 405135 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years
Secondary outcome [2] 405975 0
To compare the function of knee patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Oxford Knee Score.
Timepoint [2] 405975 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years
Secondary outcome [3] 405976 0
To compare the function of hip patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Oxford Hip Score.
Timepoint [3] 405976 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years
Secondary outcome [4] 405977 0
To compare patient difficulty (due to their knee) of knee patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Knee injury and Osteoarthritis Outcome Score (12-item).
Timepoint [4] 405977 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years
Secondary outcome [5] 405978 0
To compare patient difficulty (due to their hip) of hip patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, Hip disability and Osteoarthritis Outcome Score (12-item).
Timepoint [5] 405978 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years
Secondary outcome [6] 405979 0
To compare early pain of patients operated via Mako and non-Mako techniques. This will be achieved by employing the following instrument, VAS Pain
Timepoint [6] 405979 0
Post-operative: 4 days, 7 days, 9 days
Secondary outcome [7] 405980 0
To compare pain of patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question to rate their pain on a likert scale (where 0 represents no pain and 10 represents the worst pain imaginable). This questionnaire was designed specifically for this study.
Timepoint [7] 405980 0
Post-operative: 6 months, 1 year, 2 years
Secondary outcome [8] 405981 0
To compare mobility of patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question to rate their mobility on a likert scale that ranges from no to severe problems. This questionnaire was designed specifically for this study.
Timepoint [8] 405981 0
Post-operative: 6 months, 1 year, 2 years
Secondary outcome [9] 405982 0
To compare the health of patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question to rate their health on a likert scale (where 0 represents worst imaginable health and 100 represents the best imaginable health). This questionnaire was designed specifically for this study.
Timepoint [9] 405982 0
Post-operative: 6 months, 1 year, 2 years
Secondary outcome [10] 405983 0
To compare patient expectation of their pain between patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question on how they expect their pain to be at 6 months post-operation. This questionnaire was designed specifically for this study.
Timepoint [10] 405983 0
Pre-operative (approximately 2 weeks prior to surgery)
Secondary outcome [11] 405984 0
To compare patient expectation of their mobility between patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question on how they expect their mobility to be at 6 months post-operation. This questionnaire was designed specifically for this study.
Timepoint [11] 405984 0
Pre-operative (approximately 2 weeks prior to surgery)
Secondary outcome [12] 405985 0
To compare patient expectation of their health between patients operated via Mako and non-Mako techniques. This will be achieved by asking patients one question on how they expect their health to be at 6 months post-operation. This questionnaire was designed specifically for this study.
Timepoint [12] 405985 0
Pre-operative (approximately 2 weeks prior to surgery)
Secondary outcome [13] 405986 0
To compare length of hospital stay between patients operated via Mako and non-Mako techniques. Assessed by reviewing the Investigator's captured data.
Timepoint [13] 405986 0
At time of acute hospital discharge
Secondary outcome [14] 406045 0
To compare incidence of readmission between patients operated via Mako and non-Mako techniques. Assessed by reviewing the Investigator's captured data.
Timepoint [14] 406045 0
Acute period post-operation (i.e. from date of surgery to 30-days post-operation)
Secondary outcome [15] 406046 0
To compare incidence of revision between patients operated via Mako and non-Mako techniques. Assessed by reviewing the Investigator's captured data.
Timepoint [15] 406046 0
Reported as incidence throughout entire follow up period (i.e. from date of surgery to date of last follow up)
Secondary outcome [16] 406047 0
To compare exercise compliance between patients operated via Mako and non-Mako techniques. This will be achieved by asking patients who have scheduled exercise in the myrecovery app one question on how they perceive their compliance to scheduled exercises to be. This questionnaire was designed specifically for this study and will only assess patients who have opted in to scheduling exercise.
Timepoint [16] 406047 0
Timepoints between pre-operation and 2-years post-operation for which data is available. Since patients opt in to scheduling exercise, timepoints for analysis cannot be set and will be defined at the time of analysis.
Secondary outcome [17] 406048 0
To compare activity level between patients operated via Mako and non-Mako techniques. This will be achieved by comparing daily steps recorded by the myrecovery app. This outcome will only assess patients who have opted in to the recording of their steps.
Timepoint [17] 406048 0
Timepoints between pre-operation and 2-years post-operation for which data is available. Since patients opt in to the recording of their daily steps, timepoints for analysis cannot be set and will be defined at the time of analysis.
Secondary outcome [18] 406049 0
To monitor the early use of the myrecovery app platform particularly to report the patient compliance rates (i.e. completion rate of questionnaires) achievable with the app. This will be assessed by analysing data exported from the myrecovery app.
Timepoint [18] 406049 0
Pre-operative (approximately 2 weeks prior to surgery), Post-operative: 6 weeks, 3 months, 6 months, 1 year and 2 years

Eligibility
Key inclusion criteria
1. Patient has undergone or is to undergo a THA, TKA or PKA executed or to be executed via Mako or non-Mako techniques
2. Patient is a skeletally mature male or skeletally mature non-pregnant female aged 21 years or older at the time of consent
3. Patient has completed or is willing to complete the HREC-approved consent sign off via the myrecovery app
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a cognitive impairment, an intellectual disability or a mental illness that is thought by the Investigator to impact on their ability to comply with the requirements of the study
2. Patient is unwilling to complete the consent sign off via the myrecovery app
3. Patient has had revision/reconstruction of THA, TKA or PKA. Only primary surgeries will be included in this registry.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 310576 0
Commercial sector/Industry
Name [1] 310576 0
Stryker Australia Pty Ltd
Country [1] 310576 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] 311758 0
None
Name [1] 311758 0
Address [1] 311758 0
Country [1] 311758 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310184 0
St John of God Health Care HREC
Ethics committee address [1] 310184 0
Ethics committee country [1] 310184 0
Australia
Date submitted for ethics approval [1] 310184 0
28/02/2022
Approval date [1] 310184 0
Ethics approval number [1] 310184 0

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

Contacts
Principal investigator
Name 116786 0
Dr Dirk van Bavel
Address 116786 0
Melbourne Hip and Knee
399 Riversdale Road
Hawthorn East VIC 3123
Country 116786 0
Australia
Phone 116786 0
+61 3 98827753
Fax 116786 0
Email 116786 0
[email protected]
Contact person for public queries
Name 116787 0
Vanessa Lo Basso
Address 116787 0
Stryker Australia Pty Ltd
8 Herbert Street
St Leonards NSW 2065
Country 116787 0
Australia
Phone 116787 0
+61 2 82846118
Fax 116787 0
Email 116787 0
[email protected]
Contact person for scientific queries
Name 116788 0
Vanessa Lo Basso
Address 116788 0
Stryker Australia Pty Ltd
8 Herbert Street
St Leonards NSW 2065
Country 116788 0
Australia
Phone 116788 0
+61 2 82846118
Fax 116788 0
Email 116788 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.