ANZCTR - Registration

Registration number

ACTRN12617001161314

Ethics application status

Approved

Date submitted

4/08/2017

Date registered

8/08/2017

Date last updated

29/10/2024

Date data sharing statement initially provided

14/01/2019

Date results provided

29/10/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

A clinical registry to monitor outcomes of shoulder, hip and knee pathology

Scientific title

Prospective collection of outcomes data for orthopaedic surgeies performed at a public hospital

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1199-5098

Trial acronym

Shoulder, Hip Arthroplasty and Knee Surgery (SHARKS) Registry

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder arthritis

Shoulder dislocation/recurrent instability

Shoulder rotator cuff pathology

Knee arthritis

Knee ACL rupture

Hip Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Description of intervention(s) / exposure

Patients presenting with pathologies of the shoulder, hip or knee and treated by specialist orthopaedic surgeons.
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 for up to five years.

1. Patients diagnosed with either a recent shoulder dislocation or clinically defined glenohumeral instability: Treated with non-operative management or surgical stabilisation.

2. Patients diagnosed with rotator cuff pathology (tendinopathy; tear): Treated with non-operative management or surgical repair.

3. Patients diagnosed with glenohumeral arthritis of any aetiology: Treated with non-operative management, arthroscopic surgery or total shoulder arthroplasty.

4. Patients diagnosed with hip arthritis of any aetiology: Treated surgically (total joint arthroplasty).

5. Patients diagnosed with knee arthritis of any aetiology: Treated surgically (total joint arthroplasty).

6. Patients diagnosed with either a recent ACL Rupture or clinically defined knee instability: Treated with surgical reconstruction.

7. Patients diagnosed with arthritis primarily affecting one compartment (medial or lateral) with no patellofemoral involvement: Treated with osteotomy.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

2 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Secondary outcome [1]

Proportion of participants in whom the appropriate clinical imaging was performed, as determined by the trial consultant surgeon by medical record review.

Timepoint [1]

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]

Joint range of motion assessed by goniometry

Timepoint [2]

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]

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]

Intraoperatively and at any time point postoperatively following definitive treatment

Secondary outcome [4]

Knee instability testing - Lachman's instability test.
Specific to Knee Instability patients only.

Timepoint [4]

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]

General health assessed by Veterans Rand - 12 (VR-12)

Timepoint [5]

pre-treatment, 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 [6]

Patient reported shoulder function and instability assessed by the Oxford Shoulder Instability Score (OSIS). Specific for shoulder instability patients only.

Timepoint [6]

pre-treatment, 3 months, 12 months, 24 months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Secondary outcome [7]

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 [7]

pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Secondary outcome [8]

Patient reported shoulder function assessed by the Constant-Murley Score (CS). Specific for all Shoulder patients only

Timepoint [8]

pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Secondary outcome [9]

Patient reported shoulder and knee function assessed by Single Assessment Numeric Evaluation (SANE)

Timepoint [9]

pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).

Secondary outcome [10]

Patient reported knee function assessed by Oxford Knee Score (OKS). Specific to all Knee patients only.

Timepoint [10]

pre-treatment, 3months, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).

Secondary outcome [11]

Patient reported knee function assessed by International Knee Documentation Committee score (IKDC). Specific to Knee Instability patients only.

Timepoint [11]

pre-treatment, 3 months, 9 months, 12 months, 24 months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).

Secondary outcome [12]

Patient reported knee function assessed by Tegner score (Tegner). Specific to Knee Instability patients only.

Timepoint [12]

pre-treatment, 12months, 24months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).

Secondary outcome [13]

Composite secondary outcome: patient reported hip pain/function assessed with the Oxford Hip Score (OHS). Specific to hip arthroplasty patients only.

Timepoint [13]

Pre-treatment, 3 months, 12 months, 24 months and 5 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (surgical).

Secondary outcome [14]

Knee pain as measured with a Visual Analog Scale (VAS).

Timepoint [14]

Pre-treatment, 3, 12, 24 months and 5 years following diagnosis or definitive surgical treatment (osteotomy).

Secondary outcome [15]

Knee function as measured with the Knee Osteoarthritis Outcomes Score (KOOS). Specific to patients with Unicompartmental Arthritis only.

Timepoint [15]

Pre-treatment, 3, 12, 24 months and 5 years following diagnosis or definitive surgical treatment (osteotomy).

Secondary outcome [16]

Patient reported quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) as measured with EuroQol 5 Dimension (EQ-5D).

Timepoint [16]

Secondary outcome [17]

Patient reported quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) as measured with EuroQol 5 Dimension (EQ-5D).

Timepoint [17]

Pre-treatment, 24 months and 5 years following diagnosis or definitive surgical treatment

Secondary outcome [18]

Patient reported shoulder activity level as measured by the Shoulder Activity Scale (SAS). Specific to patients with Shoulder Arthritis and Shoulder Instability.

Timepoint [18]

Pre-treatment, 24 months and 5 years following diagnosis or definitive surgical treatment

Secondary outcome [19]

Patient reported shoulder activity level as measured by the Shoulder Activity Scale (SAS). Specific to patients with Shoulder Arthritis and Shoulder Instability.

Timepoint [19]

Pre-treatment, 12 months, 24 months and 5 years following diagnosis or definitive surgical treatment

Secondary outcome [20]

Patient reported Return to Activity Expectations (RAE). Specific to patients with Shoulder Arthritis and Knee Deformity.

Timepoint [20]

Pre-treatment, 12 months, 24 months and 5 years following diagnosis or definitive surgical treatment

Secondary outcome [21]

Patient reported Return to Activity Expectations (RAE). Specific to patients with Shoulder Arthritis and Knee Deformity.

Timepoint [21]

12 months following diagnosis or definitive surgical treatment

Secondary outcome [22]

Patient reported Return to Sport Expectations (RSE). Specific to patients with Shoulder Instability and Knee Instability.

Timepoint [22]

12 months following diagnosis or definitive surgical treatment

Secondary outcome [23]

Patient reported Return to Sport Expectations (RSE). Specific to patients with Shoulder Instability and Knee Instability.

Timepoint [23]

12 months following diagnosis or definitive surgical treatment

Secondary outcome [24]

Patient reported expectations of orthopaedic surgery as measured by the Expectations Domain of the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS Expectations). Specific to patients with Shoulder Arthritis, Knee Arthritis, Hip Arthritis, and Knee Deformity.

Timepoint [24]

12 months following diagnosis or definitive surgical treatment

Secondary outcome [25]

Patient reported expectations of orthopaedic surgery as measured by the Expectations Domain of the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS Expectations). Specific to patients with Shoulder Arthritis, Knee Arthritis, Hip Arthritis, and Knee Deformity.

Timepoint [25]

Pre-treatment

Secondary outcome [26]

Patient reported satisfaction with orthopaedic surgery as measured by the Satisfaction Domain of the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS Satisfaction). Specific to patients with Shoulder Arthritis, Knee Arthritis, Knee Instability, Hip Arthritis, and Knee Deformity.

Timepoint [26]

Pre-treatment

Secondary outcome [27]

Patient reported satisfaction with orthopaedic surgery as measured by the Satisfaction Domain of the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS Satisfaction). Specific to patients with Shoulder Arthritis, Knee Arthritis, Knee Instability, Hip Arthritis, and Knee Deformity.

Timepoint [27]

12 months, 24 months and 5 years following definitive surgical treatment.

Secondary outcome [28]

Patient reported Treatment Satisfaction.

Timepoint [28]

12 months, 24 months and 5 years following definitive surgical treatment.

Secondary outcome [29]

Patient reported Treatment Satisfaction.

Timepoint [29]

12 months, 24 months and 5 years following diagnosis or definitive surgical treatment. Specific to patients with Shoulder Arthritis, Knee Arthritis or Hip Arthritis.

Secondary outcome [30]

Patient reported disease-specific quality of life as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS). Specific to patients with Shoulder Arthritis.

Timepoint [30]

12 months, 24 months and 5 years following diagnosis or definitive surgical treatment. Specific to patients with Shoulder Arthritis, Knee Arthritis or Hip Arthritis.

Secondary outcome [31]

Patient reported disease-specific quality of life as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS). Specific to patients with Shoulder Arthritis.

Timepoint [31]

Pre-treatment, 3 months, 12 months, 24 months and 5 years following diagnosis or definitive surgical treatment.

Secondary outcome [32]

Patient reported evaluation of return to sports after injury, as measured by the Anterior Cruciate Ligament - Return to Sport after Injury Short Form (ACL RSI-SF). Specific to patients with Knee Instability

Timepoint [32]

Pre-treatment, 3 months, 12 months, 24 months and 5 years following diagnosis or definitive surgical treatment.

Secondary outcome [33]

Patient reported evaluation of return to sports after injury, as measured by the Anterior Cruciate Ligament - Return to Sport after Injury Short Form (ACL RSI-SF). Specific to patients with Knee Instability

Timepoint [33]

9 months following diagnosis or definitive surgical treatment.

Secondary outcome [34]

Patient reported kinesiophobia (fear of movement or re-injury), as measured by The Tampa Scale 11 (TSK-11) of Kinesiophobia. Specific to patients with Knee Instability

Timepoint [34]

9 months following diagnosis or definitive surgical treatment.

Secondary outcome [35]

Patient reported kinesiophobia (fear of movement or re-injury), as measured by The Tampa Scale 11 (TSK-11) of Kinesiophobia. Specific to patients with Knee Instability

Timepoint [35]

9 months following diagnosis or definitive surgical treatment.

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.
Consenting to being part of the research registry

Minimum age

16 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

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

1889

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queen Elizabeth II Jubilee Hospital - Coopers Plains

Recruitment postcode(s) [1]

4108 - Coopers Plains

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Metro South Health

Country [1]

Australia

Primary sponsor type

Hospital

Name

QEII Jubilee Hospital

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

EBM Analytics

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Research Governance

Ethics committee address [1]

Centres for Health Research
Princess Alexandra Hospital
37 Kent Street
Woolloongabba
QLD, 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2016

Approval date [1]

08/11/2016

Ethics approval number [1]

HREC/16/QPAH/732

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

Public notes

Contacts

Principal investigator

Name

Dr Christopher Bell

Address

QEII Jubilee Hospital
360 Kessels RoadTroughton Road
Coopers Plains
QLD 4108

Country

Australia

Phone

+61 7 3182 6111

Email

[email protected]

Contact person for public queries

Name

Corey Scholes

Address

EBM Analytics
119 Willoughby Road
Crows Nest
NSW 2065

Country

Australia

Phone

+61411032987

Email

[email protected]

Contact person for scientific queries

Name

Corey Scholes

Address

EBM Analytics
119 Willoughby Road
Crows Nest
NSW 2065

Country

Australia

Phone

+61411032987

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically