Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001161314
Ethics application status
Approved
Date submitted
4/08/2017
Date registered
8/08/2017
Date last updated
21/06/2021
Date data sharing statement initially provided
14/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical registry to monitor outcomes of shoulder and knee pathology
Scientific title
Prospective collection of outcomes for patients undergoing surgery of the shoulder, hip and knee performed at a public hospital
Secondary ID [1] 292340 0
Nil known
Universal Trial Number (UTN)
U1111-1199-5098
Trial acronym
SHARK (Shoulder, hip, arthroplasty and knee surgery)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder arthritis 304087 0
Shoulder dislocation/recurrent instability 304088 0
Shoulder rotator cuff pathology 304089 0
Knee arthritis 304091 0
Knee ACL rupture 304092 0
Hip Osteoarthritis 315475 0
Condition category
Condition code
Musculoskeletal 303424 303424 0 0
Osteoarthritis
Musculoskeletal 303425 303425 0 0
Other muscular and skeletal disorders
Surgery 303634 303634 0 0
Other surgery

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, hip or knee and treated by specialist orthopaedic surgeon.
Follow-up protocols will be unchanged from the surgeons usual clinical practice for the procedures being monitored. That is, no special treatment will be assigned to the participating patient. At the time of surgery, operative details will be added to the database. The database allows the extraction of patient information that allows research to be conducted. Baseline clinical measurements and outcomes scores (identified in this trial) will be collected up to the time periods identified below.

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 (tendinopathy; tear): Treated with non-operative management or surgical repair. Followed for a duration of 5 years.

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

4. Patients diagnosed with hip arthritis of any aetiology: Treated surgically (total joint arthroplasty). Followed for a duration of 5 years.

5. Patients diagnosed with knee arthritis of any aetiology: Treated surgically (total joint arthroplasty). Followed for a duration of 5 years.

6. Patients diagnosed with either a recent ACL Rupture or clinically defined knee instability: Treated with surgical reconstruction. Followed for a duration of 5 years.

7. Patients diagnosed with arthritis primarily affecting one compartment (medial or lateral) with no patellofemoral involvement: Treated with osteotomy. Followed for a duration of 5 years.
Intervention code [1] 298653 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302809 0
UpdateThe incidence of patients that are deemed a "failure to cure" following definitive treatment Insufficient improvement in patient reported outcome measures (function or pain) - Based on secondary outcomes identified and matched to the specific cohort. eg. A CS score with a MCID of 10.4 for rotator cuff repair; adverse findings on post-treatment medical imaging - determined by the reviewing surgeon based on imaging secondary outcomes identified; positive signs of instability, weakness or other primary pathology during clinical follow-up - as determined by the reviewing surgeon based on strength and instability tests identified as secondary outcomes; failure to improve shoulder, hip or knee range of motion - as determined by the reviewing surgeon based on range of motion tests identified as secondary outcomes.
Timepoint [1] 302809 0
2 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [1] 337107 0
Proportion of participants in whom the appropriate clinical imaging was performed, as determined by the trial consultant surgeon by medical record review.
Timepoint [1] 337107 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 [2] 337108 0
Joint range of motion assessed by goniometry
Timepoint [2] 337108 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 [3] 337109 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 Frangiamore et al 2015.
Timepoint [3] 337109 0
intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)
Secondary outcome [4] 337110 0
Shoulder strength in forward elevation measured using manual muscle testing and graded using the British Medical Research Council (MRC) system.
Timepoint [4] 337110 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 [5] 337111 0
Knee instability testing - Lachman's instability test.
Specific to Knee Instability patients only.
Timepoint [5] 337111 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] 337112 0
General health assessed by Veterans Rand - 12 (VR-12)
Timepoint [6] 337112 0
pre-treatment, and 12months, 2years, 4years 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 [7] 337113 0
Patient reported shoulder function assessed by Oxford Shoulder Score (OSS). Specific for all shoulder patients only.
Timepoint [7] 337113 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 [8] 337114 0
Patient reported shoulder function and instability assessed by the Oxford Shoulder Instability Score (OSIS). Specific for shoulder instability patients only.
Timepoint [8] 337114 0
pre-treatment, 3months, 12months and 24months after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [9] 337115 0
Patient reported shoulder function and rotator cuff pathology symptoms assessed by the Western Ontario Rotator Cuff index (WORC). Specific for Rotator Cuff shoulder patients only.
Timepoint [9] 337115 0
pre-treatment, 3months, 6months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [10] 337116 0
Patient reported shoulder function assessed by the Constant-Murley Score (CS). Specific for all Shoulder patients only
Timepoint [10] 337116 0
pre-treatment, 3months, 6months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [11] 337117 0
Patient reported shoulder and knee function assessed by Single Assessment Numeric Evaluation (SANE)
Timepoint [11] 337117 0
pre-treatment, 3months, 6months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [12] 337118 0
Patient reported knee function assessed by Oxford Knee Score (OKS). Specific to all Knee patients only.
Timepoint [12] 337118 0
pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).
Secondary outcome [13] 337119 0
Patient reported knee function assessed by Internation Knee Documentation Committee score (IKDC). Specific to Knee Instability patients only.
Timepoint [13] 337119 0
pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).
Secondary outcome [14] 337120 0
Patient reported knee function assessed by Tegner score (Tegner). Specific to Knee Instability patients only.
Timepoint [14] 337120 0
pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).
Secondary outcome [15] 337646 0
Shoulder strength in internal rotation measured using manual muscle testing and graded using the British Medical Research Council (MRC) system.
Timepoint [15] 337646 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 [16] 337647 0
Shoulder strength in external rotation measured using manual muscle testing and graded using the British Medical Research Council (MRC) system.
Timepoint [16] 337647 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 [17] 377573 0
Composite secondary outcome: patient reported hip pain/function assessed with the Oxford Hip Score (OHS). Specific to hip arthroplasty patients only.
Timepoint [17] 377573 0
Pre-treatment, 12 months, 24 months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).
Secondary outcome [18] 377574 0
Knee pain as measured with a Visual Analog Scale (VAS). Specific to patients with Unicompartnental Arthritis only.
Timepoint [18] 377574 0
Pre-treatment, 3, 6, 12, 24 months and 5 years following diagnosis or definitive surgical treatment (osteotomy).
Secondary outcome [19] 377575 0
Knee function as measured with the Knee Osteoarthritis Outcomes Score (KOOS). Specific to patients with Unicompartnental Arthritis only.
Timepoint [19] 377575 0
Pre-treatment, 3, 6, 12, 24 months and 5 years following diagnosis or definitive surgical treatment (osteotomy).

Eligibility
Key inclusion criteria
Diagnosed with orthopaedic shoulder, hip or knee pathology in one of the identified cohorts.
Undergoing treatment by one of the participating orthopaedic consultant surgeons as a public patient at QEII Jubilee Hospital or Mater Adults Hospital.
Consenting to being part of the research registry
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient-reported outcomes: Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder).
Revocation of consent for research use of personal data.

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 public 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
Recruiting
Date of first participant enrolment
Anticipated
21/08/2017
Actual
28/07/2017
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
1/07/2032
Actual
Sample size
Target
2500
Accrual to date
996
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8565 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 8566 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 16671 0
4101 - South Brisbane
Recruitment postcode(s) [2] 16670 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 296888 0
Government body
Name [1] 296888 0
Metro South Health
Country [1] 296888 0
Australia
Primary sponsor type
Hospital
Name
QEII Jubilee Hospital
Address
360 Kessels RoadTroughton Road, Coopers Plains QLD 4108
Country
Australia
Secondary sponsor category [1] 295895 0
None
Name [1] 295895 0
Address [1] 295895 0
Country [1] 295895 0
Other collaborator category [1] 279649 0
Commercial sector/Industry
Name [1] 279649 0
EBM Analytics
Address [1] 279649 0
119 Willoughby Road, Crows Nest, 2065, NSW
Country [1] 279649 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298108 0
Metro South Health Research Governance
Ethics committee address [1] 298108 0
Centres for Health Research
Princess Alexandra Hospital
37 Kent Street
Woolloongabba
QLD, 4102
Ethics committee country [1] 298108 0
Australia
Date submitted for ethics approval [1] 298108 0
01/10/2016
Approval date [1] 298108 0
08/11/2016
Ethics approval number [1] 298108 0
HREC/16/QPAH/430

Summary
Brief summary
To collect patient outcome data into a database that allows research to be generated. This occurs by identifying trends, systematically recognising unexpected outcomes from surgical techniques and allowing hypothesis generation to be tested in a retrospective manner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76018 0
Dr Christopher Bell
Address 76018 0
QEII Jubilee Hospital
360 Kessels RoadTroughton Road
Coopers Plains
QLD 4108
Country 76018 0
Australia
Phone 76018 0
+61 7 3182 6111
Fax 76018 0
Email 76018 0
christopher.bell@health.qld.gov.au
Contact person for public queries
Name 76019 0
Mr MacDougal Cowley
Address 76019 0
EBM Analytics
119 Willoughby Road
Crows Nest
NSW 2065
Country 76019 0
Australia
Phone 76019 0
+61434829080
Fax 76019 0
Email 76019 0
mcowley@ebma.com.au
Contact person for scientific queries
Name 76020 0
Dr Corey Scholes
Address 76020 0
EBM Analytics
119 Willoughby Road
Crows Nest
NSW 2065
Country 76020 0
Australia
Phone 76020 0
+61411032987
Fax 76020 0
Email 76020 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
Data will be identifiable and thus remains confidential.


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
SourceTitleYear of PublicationDOI
Dimensions AIImplementation and quality assessment of a clinical orthopaedic registry in a public hospital department2020https://doi.org/10.1186/s12913-020-05203-8
N.B. These documents automatically identified may not have been verified by the study sponsor.