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Trial registered on ANZCTR

Registration number

ACTRN12619000770167

Ethics application status

Approved

Date submitted

17/04/2019

Date registered

23/05/2019

Date last updated

29/05/2024

Date data sharing statement initially provided

23/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A clinical registry to monitor outcomes of upper limb pathology (PRULO)

Scientific title

Prospective collection of outcomes for patients undergoing surgery of the upper limb (shoulder, elbow, hand or wrist)

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1230-6736

Trial acronym

PRULO

Linked study record

Health condition

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

Rotator Cuff pathology

Glenohumeral Osteoarthritis

Adhesive Capsulitis

Glenohumeral instability

Carpal Tunnel Syndrome

Elbow osteochondral/soft tissue pathology

Shoulder osteochondral/soft tissue pathology (other)

Hand/wrist osteochondral/soft tissue pathology (other)

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Other surgery

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

Patients presenting with pathologies of the upper limb and referred to specialist orthopaedic review are requested to provide consent to inclusion in the study (incorporating access to records relating to consultations and procedures undertaken by the Surgeon, and patient completion of pre and postoperative questionnaires). Orthopaedic interventions consist of the following:

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

2. Patients diagnosed with glenohumeral arthritis of any aetiology: Treated with arthroscopic surgery or total shoulder arthroplasty. Followed for a minimum duration of 2 years.

3. Patients diagnosed with either a recent shoulder dislocation or clinically defined glenohumeral instability: Treated with surgical stabilisation. Followed for a minimum duration of 2 years.

4. Patients diagnosed with frozen shoulder/adhesive capsulitis managed non-operatively or treated surgically. Followed for a minimum duration of 2 years.

5. Patients diagnosed with a shoulder pathology not fitting matching other cohorts. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years.

6. Patients diagnosed with an elbow pathology of any aetiology diagnosed by the consulting surgeon. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years.

7. Patients diagnosed with carpal tunnel syndrome treated with arthoscopic carpal tunnel release. Followed for a minimum duration of 2 years.

8. Patients diagnosed with a hand or wrist pathology not matching other cohorts. Managed nonoperatively or treated surgically. Followed for a minimum duration of 2 years.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The 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.

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 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]

Joint range of motion assessed by goniometry

Timepoint [1]

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 [2]

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. This data will be obtained through medical records, and may be reported by participants during follow-up appointments with the specialist.

Timepoint [2]

intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)

Secondary outcome [3]

MODEMs Expectation Scale

Timepoint [3]

pre-treatment

Secondary outcome [4]

QuickDASH: General upper limb function score

Timepoint [4]

pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Secondary outcome [5]

EQ-5D-5L: Quality of life measure

Timepoint [5]

pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Secondary outcome [6]

Return to activity (work or sport) - using a standardised questionnaire. For work, the patient is asked whether they were able to return to pre-surgery or pre-injury work activities, and nominates yes or no. For sports, patients are asked to specify their normal level of sports participation, and are asked to rate their current level as lower/same/higher than normal.

Timepoint [6]

3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Secondary outcome [7]

Patient Satisfaction - measured using a single-question likert scale

Timepoint [7]

3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Secondary outcome [8]

Oxford shoulder instability score (OSIS) [Instability cohort only]

Timepoint [8]

pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Secondary outcome [9]

Western Ontario Rotator Cuff Scale (WORC) [Rotator cuff cohort only]

Timepoint [9]

pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.

Eligibility

Key inclusion criteria

Diagnosed with orthopaedic shoulder, elbow, hand or wrist pathology in one of the identified cohorts.
Undergoing treatment by one of the participating orthopaedic consultant surgeons at Geelong Orthopaedics
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?

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 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

1/10/2020

Actual

13/10/2020

Date of last participant enrolment

Anticipated

12/10/2030

Actual

Date of last data collection

Anticipated

12/10/2035

Actual

Sample size

Target

3000

Accrual to date

2651

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3220 - Geelong

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mr Kevin Eng

Address [1]

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Geelong Orthopaedics

Address [2]

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country [2]

Australia

Funding source category [3]

Self funded/Unfunded

Name [3]

Prof Richard Page

Address [3]

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

Johnson & Johnson Medical Pty Ltd

Address [4]

Country [4]

Australia

Primary sponsor type

Individual

Name

Mr Kevin Eng

Address

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barwon Health HREC

Ethics committee address [1]

PO Box 281
Geelong VIC 3220

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2019

Approval date [1]

19/07/2019

Ethics approval number [1]

19/70

Summary

Brief summary

This is an implementation study, aiming to design and implement a clinical outcomes orthopaedic registry for patients presenting to a single centre practice with upper limb pathologies. The purpose of this registry is to report patient outcomes after treatment through a prospective, consecutive observational cohort study design.

This clinical registry will collate and store patient outcomes collected routinely as part of the standard clinical pathway for upper limb pathology treatments. Outcomes will include objective joint function, patient reported outcomes (pain, satisfaction, quality of life), radiological findings and rates of revision surgery or complications.

Recruitment will include all patients presenting with upper limb pathology to the principal  or associate investigators at a single clinical practice (Geelong Orthopaedics). Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings, pathology, and functional analysis. Patient evaluation will be completed routinely as part of the standard clinical pathway performed by the principal and associate investigators via the consulting rooms at Geelong Orthopaedics or hospital clinics. Patients will in addition be requested to complete a set of questionnaires (EQ-5D, Oxford shoulder scores (Pain and Instability scores), Quick DASH (upper limb function score), American Shoulder and Elbow Society (ASES) Score, Western Ontario Rotator Cuff (WORC) Score) and return to activity questions to enable evaluation of patient reported outcomes and complete physical assessments as part of the post- treatment follow up.

The clinical outcomes of individual patients will be monitored for up to 5 years.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kevin Eng

Address

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country

Australia

Phone

+61352226602

Fax

[email protected]

Contact person for public queries

Name

Kevin Eng

Address

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country

Australia

Phone

+61352226602

Fax

[email protected]

Contact person for scientific queries

Name

Kevin Eng

Address

Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220

Country

Australia

Phone

+61352226602

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD contains confidential information

What supporting documents are/will be available?

Doc. No.	Type	Email
5699	Ethical approval	[email protected]
5700	Study protocol	[email protected]
5701	Statistical analysis plan	[email protected]
5702	Informed 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

Source	Title	Year of Publication	DOI
Dimensions AI	Patient Registry of Upper Limb Outcomes (PRULO): a protocol for an orthopaedic clinical quality registry to monitor treatment outcomes	2023	https://doi.org/10.1093/jsprm/snad014

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically