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Trial registered on ANZCTR


Registration number
ACTRN12617000864325
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
13/06/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical registry to monitor outcomes of shoulder and elbow pathology
Scientific title
A clinical quality registry to monitor outcomes of shoulder and elbow pathology among private patients referred to an orthopaedic clinic
Secondary ID [1] 291853 0
MSEC - CROSEP
Universal Trial Number (UTN)
U1111-1196-2935
Trial acronym
CROSEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder arthritis 303117 0
Elbow arthritis 303118 0
Shoulder dislocation/recurrent instability 303119 0
Shoulder rotator cuff pathology 303120 0
Clavicle/humerus/scapula fracture 303121 0
Acromioclavicular dislocation/instability 303122 0
Elbow trauma 303123 0
Shoulder arthroplasty complication/revision/failure 303124 0
Elbow tendon pathology 303125 0
Condition category
Condition code
Musculoskeletal 302571 302571 0 0
Osteoarthritis
Injuries and Accidents 302572 302572 0 0
Fractures
Musculoskeletal 302573 302573 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Patients presenting with pathologies of the shoulder or elbow and referred to specialist orthopaedic review.

1. Patients diagnosed with either a recent shoulder dislocation or clinically defined glenohumeral instability: Treated with non-operative management or surgical stabilisation. Followed for a duration of 2 years.

2. Patients diagnosed with rotator cuff pathology (subacromial impingement; tendinopathy; tear): Treated with non-operative management or surgical repair. Followed for a duration of 2 years.

3. Patients diagnosed with acromioclavicular instability of any aetiology: Treated with non-operative management or surgical stabilisation. Followed for a duration of 2 years.

4. Patients diagnosed with glenohumeral arthritis of any aetiology: Treated with non-operative management, arthroscopic surgery or total shoulder arthroplasty. Followed for a duration of 5 years.

5. Patients diagnosed with acute fracture of the scapula, clavicle or humerus (including associated glenohumeral dislocation): Treated with non-operative management, internal fixation or total shoulder arthroplasty. Followed for a duration of 2 years.

6. Patients diagnosed with frozen shoulder, prominent hardware of the shoulder, prosthesis issues, extrinsic tendon injury or neuological injury affecting the shoulder: Managed non-operatively or treated surgically (arthroscopic or open repair). Followed for a duration of 2 years.

7. Patients with a primary diagnosis invloving the elbow (including arthritis, fracture, tendon/ligament injury or instability event): Managed non-operatively or treated surgically (stabilisation, repair or internal fixation). Followed for a duration of 2 years.
Intervention code [1] 297966 0
Diagnosis / Prognosis
Intervention code [2] 298123 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301987 0
The incidence of patients that are deemed a "failure to cure" following definitive treatment

Insufficient improvement in patient reported outcome measures (function or pain); adverse findings on post-treatment medical imaging; positive signs of instability, weakness or other primary pathology during clinical follow-up; failure to improve shoulder or elbow range of motion
Timepoint [1] 301987 0
6months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [1] 335080 0
General health assessed by Veterans Rand - 12 (VR-12)
Timepoint [1] 335080 0
pre-treatment, and 12months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [2] 335081 0
Clinical imaging - radiographs (XR), computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US) appropriate to the diagnosis
Timepoint [2] 335081 0
pre-treatment, 6weeks, 3months, 6months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the diagnosis.
Secondary outcome [3] 335082 0
Joint range of motion assessed by goniometry
Timepoint [3] 335082 0
pre-treatment, 3months, 6months, 12months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [4] 335083 0
Complications and adverse events: any deviation from the ideal postoperative course that is not inherent in the procedure and does not comprise a failure to cure. E.g. surgical site infection as per the criteria described in Parvizi et al 2011 (CORR, 469).
Timepoint [4] 335083 0
intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)
Secondary outcome [5] 335734 0
Shoulder strength in forward elevation, internal rotation, and external rotation, measured using manual muscle testing and graded using the British Medical Research Council (MRC) system.
Timepoint [5] 335734 0
pre-treatment, 3months, 6months, 12months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [6] 335833 0
Patient-reported shoulder function assessed by the American Shoulder and Elbow Score (ASES)
Timepoint [6] 335833 0
pre-treatment, 3months, 6months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [7] 335837 0
Patient reported shoulder function and instability assessed by the Western Ontario Should Instability score (WOSI)
Timepoint [7] 335837 0
pre-treatment, 3months, 6months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [8] 335838 0
Patient reported shoulder function and rotator cuff pathology symptoms assessed by the Western Ontario Rotator Cuff index (WORC)
Timepoint [8] 335838 0
pre-treatment, 3months, 6months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [9] 335839 0
Patient reported elbow function assessed by the Patient Rated Elbow Evaluation (PREE)
Timepoint [9] 335839 0
pre-treatment, 3months, 6months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [10] 379655 0
Single assessment numeric evaluation (SANE) score
Timepoint [10] 379655 0
pre-treatment, 3months, 6months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Eligibility
Key inclusion criteria
Patients presenting for diagnosis and treatment to one of the participating orthopaedic surgeons as a private patient (private insured, public uninsured as a private patient)
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Elects to opt-out of the registry
- Suffers from a neurological, psychological pathology that precludes them from providing patient feedback on treatment outcomes
- unable to provide informed consent to treatment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation; The registry has been designed to capture >80% of patients presenting to the participating clinic as per the inclusion criteria to provide adequate internal validity of the results and generalisability to patients presenting to a private clinic in a major city of Australia.

The registry will routinely report data quality with respect to the core dataset. This will incorporate data completeness, consistency and validity. Registry primary and secondary outcomes will be reported annually.

Analyses relevant to each patient cohort will be pre-planned specific to the prospective questions identified for each.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/07/2017
Actual
24/07/2017
Date of last participant enrolment
Anticipated
1/07/2027
Actual
5/02/2020
Date of last data collection
Anticipated
1/07/2032
Actual
Sample size
Target
15000
Accrual to date
2990
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8063 0
Cabrini Brighton - Brighton
Recruitment hospital [2] 8064 0
St John of God Hospital - Bendigo - Bendigo
Recruitment hospital [3] 8065 0
Linacre Private Hospital - Hampton
Recruitment postcode(s) [1] 16104 0
3186 - Brighton
Recruitment postcode(s) [2] 16107 0
3186 - Brighton North
Recruitment postcode(s) [3] 16106 0
3188 - Hampton
Recruitment postcode(s) [4] 16105 0
3550 - Bendigo
Recruitment postcode(s) [5] 16108 0
3550 - Bendigo South

Funding & Sponsors
Funding source category [1] 296352 0
Self funded/Unfunded
Name [1] 296352 0
Mr Harry Clitherow
Country [1] 296352 0
Australia
Funding source category [2] 296707 0
Self funded/Unfunded
Name [2] 296707 0
Mr Brendan Soo
Country [2] 296707 0
Australia
Primary sponsor type
Individual
Name
Mr Harry Clitherow
Address
31 NORMANBY ST BRIGHTON 3186 VIC - Melbourne Shoulder and Elbow Centre
Country
Australia
Secondary sponsor category [1] 295668 0
None
Name [1] 295668 0
Address [1] 295668 0
Country [1] 295668 0
Other collaborator category [1] 279581 0
Commercial sector/Industry
Name [1] 279581 0
EBM Analytics
Address [1] 279581 0
119 Willoughby Road, Crows Nest, NSW, 2065
Country [1] 279581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297582 0
Cabrini Hospital Human Research Ethics Committee
Ethics committee address [1] 297582 0
243 New Street Brighton VIC 3186
Ethics committee country [1] 297582 0
Australia
Date submitted for ethics approval [1] 297582 0
30/03/2017
Approval date [1] 297582 0
09/05/2017
Ethics approval number [1] 297582 0
CHREC 06-15-05-17

Summary
Brief summary
The proposed registry is necessary to monitor the natural history of shoulder pathologies occurring in the general population and to monitor short-term and long-term patient outcomes associated with the condition and contemporary treatment options. The aim of the registry is to objectively assess patient-centred outcomes of definitive management for shoulder and elbow pathologies.

Patients will be enrolled in an opt-out clinical registry (longitudinal observational design) hosted by the clinic providing diagnosis and treatment of their condition. Patient outcomes, clinical imaging, joint function, as well as treatment and clinical information will be collected as part of standard of care and collated into an electronic registry maintained at the clinic. Patients will be monitored for up to 5years after definitive treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74510 0
Mr Harry Clitherow
Address 74510 0
Melbourne Shoulder and Elbow Centre - 31 NORMANBY ST BRIGHTON, VIC 3186
Country 74510 0
Australia
Phone 74510 0
+61 3 9592 3388
Fax 74510 0
Email 74510 0
harry@harryclitherow.com.au
Contact person for public queries
Name 74511 0
Meredith Harrison-Brown
Address 74511 0
EBM Analytics - 119 Willoughby Road, Crows Nest, NSW 2065
Country 74511 0
Australia
Phone 74511 0
+61 431932519
Fax 74511 0
Email 74511 0
mharrisonbrown@ebma.com.au
Contact person for scientific queries
Name 74512 0
Corey Scholes
Address 74512 0
EBM Analytics - 119 Willoughby Road, Crows Nest, NSW, 2065
Country 74512 0
Australia
Phone 74512 0
+61 411032987
Fax 74512 0
Email 74512 0
cscholes@ebma.com.au

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.