Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000118505
Ethics application status
Approved
Date submitted
28/11/2023
Date registered
9/02/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
9/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-Reported Outcomes in Practice for Enhanced Learning and Research (PROPELLER): A national prospective clinical quality registry of orthopaedic care
Scientific title
Patient-Reported Outcomes in Practice for Enhanced Learning and Research (PROPELLER): A national prospective clinical quality registry of orthopaedic care
Secondary ID [1] 310834 0
None
Universal Trial Number (UTN)
U1111-1300-9777
Trial acronym
PROPELLER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Injury 331842 0
Musculoskeletal Disorders 332163 0
Condition category
Condition code
Musculoskeletal 328583 328583 0 0
Osteoarthritis
Musculoskeletal 328584 328584 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
This registry will monitor short and long-term patient outcomes associated with orthopaedic pathology using clinical data collected routinely as part of standard care, stored in an integrated and quality controlled database.

In particular, the registry will objectively analyse assessments of function, patient reported
outcomes (including pain, satisfaction, quality of life and return to activity), radiological findings and rates of complications or revisions across the various modes of treatments implemented by the participating surgeons. Patient, pathology and management factors associated with treatment success or failure at a minimum of 6 months and up to 5 year follow up will be reported via an observational consecutive cohort study.
Intervention code [1] 327492 0
Not applicable
Comparator / control treatment
Patients offered surgery to treat a musculoskeletal condition, but defer or decline surgery for non-surgical management. Examples of non-surgical management include physiotherapy, ultrasound guided injections and the use of orthotics. Patients may also elect to undergo surgery with someone else.
Control group
Active

Outcomes
Primary outcome [1] 336691 0
Treatment survival (composite outcome)
Timepoint [1] 336691 0
Any time between date of treatment and maximum follow up (10 years)
Secondary outcome [1] 429344 0
Complications and adverse events, defined by deviation from the ideal postoperative course that is not inherent in the procedure and does not comprise a failure to cure.
Timepoint [1] 429344 0
Any time between day of surgery and 6 weeks after surgery
Secondary outcome [2] 431061 0
General health assessed by the Veterans Rand - 12 (VR-12) questionnaire
Timepoint [2] 431061 0
Baseline (pre-treatment), 6months and 12months after treatment.
Secondary outcome [3] 431062 0
Lower limb function assessed by the Lower Extremity Functional Scale (LEFS)
Timepoint [3] 431062 0
Baseline (pre-treatment), 6months and 12months after treatment.
Secondary outcome [4] 431063 0
Pain assessed by the modified Brief Pain Inventory - Short Form (BPI-SF)
Timepoint [4] 431063 0
Baseline (pre-treatment), 6months and 12months after treatment.

Eligibility
Key inclusion criteria
Adult patients presenting for surgical review of orthopaedic or musculoskeletal conditions affecting the upper or lower limbs or pelvis.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sign and return opt-out form;
Unable to comprehend or communicate responses to standardised questions on forms provided electronically;
Request to be excluded from questionnaires.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to the anticipated limited sample size, the initial analyses of Registry data will comprise annual reporting of summary statistics and pre-postoperative change in outcomes scores at each follow-up. As the registry increases in size, analyses will incorporate regression modelling to identify factors independently predictive of later outcomes at approximately 2 years post treatment. A detailed outline of planned statistical analysis for each cohort can be obtained from the Principal Investigator on request.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2034
Actual
Date of last data collection
Anticipated
1/02/2044
Actual
Sample size
Target
30000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315079 0
Commercial sector/Industry
Name [1] 315079 0
EBM Analytics
Country [1] 315079 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EBM Analytics
Address
119 Willoughby Road, Crows Nest, NSW 2065
Country
Australia
Secondary sponsor category [1] 317351 0
None
Name [1] 317351 0
None
Address [1] 317351 0
Country [1] 317351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314026 0
Bellberry Limited
Ethics committee address [1] 314026 0
Ethics committee country [1] 314026 0
Australia
Date submitted for ethics approval [1] 314026 0
06/11/2023
Approval date [1] 314026 0
15/01/2024
Ethics approval number [1] 314026 0
2023-08-989

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

Contacts
Principal investigator
Name 130166 0
Dr Corey Scholes
Address 130166 0
EBM Analytics, 119 Willoughby Road, Crows Nest NSW 2065, Australia
Country 130166 0
Australia
Phone 130166 0
+61 421160417
Fax 130166 0
Email 130166 0
[email protected]
Contact person for public queries
Name 130167 0
Corey Scholes
Address 130167 0
EBM Analytics, 119 Willoughby Road, Crows Nest NSW 2065, Australia
Country 130167 0
Australia
Phone 130167 0
+61 421160417
Fax 130167 0
Email 130167 0
[email protected]
Contact person for scientific queries
Name 130168 0
Corey Scholes
Address 130168 0
EBM Analytics, 119 Willoughby Road, Crows Nest NSW 2065, Australia
Country 130168 0
Australia
Phone 130168 0
+61 421160417
Fax 130168 0
Email 130168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant-level data or aggregate outcomes data
When will data be available (start and end dates)?
Beginning 2 years from study start date. No end date.
Available to whom?
De-identified participant-level data may be shared with investigators following approval by a reviewing HREC.
Available for what types of analyses?
Research projects approved by an NHMRC-certified HREC
How or where can data be obtained?
Send email to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20721Study protocol  [email protected]
20722Statistical analysis plan  [email protected]
20723Ethical approval  [email protected]
21068Informed consent form  [email protected]



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.