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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
15/11/2019
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] 297795 0
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 312142 0
Glenohumeral Osteoarthritis 312143 0
Adhesive Capsulitis 312148 0
Glenohumeral instability 312149 0
Carpal Tunnel Syndrome 312150 0
Elbow osteochondral/soft tissue pathology 312151 0
Shoulder osteochondral/soft tissue pathology (other) 312152 0
Hand/wrist osteochondral/soft tissue pathology (other) 312153 0
Condition category
Condition code
Musculoskeletal 310695 310695 0 0
Osteoarthritis
Musculoskeletal 310696 310696 0 0
Other muscular and skeletal disorders
Surgery 310697 310697 0 0
Other surgery
Musculoskeletal 310718 310718 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
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] 314034 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319561 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) - 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] 319561 0
2 years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment (non-operative OR surgical).
Secondary outcome [1] 368675 0
Joint range of motion assessed by goniometry
Timepoint [1] 368675 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 [2] 368676 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. This data will be obtained through medical records, and may be reported by participants during follow-up appointments with the specialist.
Timepoint [2] 368676 0
intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)
Secondary outcome [3] 370005 0
MODEMs Expectation Scale
Timepoint [3] 370005 0
pre-treatment
Secondary outcome [4] 370409 0
QuickDASH: General upper limb function score
Timepoint [4] 370409 0
pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.
Secondary outcome [5] 370410 0
EQ-5D-5L: Quality of life measure
Timepoint [5] 370410 0
pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.
Secondary outcome [6] 370411 0
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] 370411 0
3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.
Secondary outcome [7] 370412 0
Patient Satisfaction - measured using a single-question likert scale
Timepoint [7] 370412 0
3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.
Secondary outcome [8] 370413 0
Oxford shoulder instability score (OSIS) [Instability cohort only]
Timepoint [8] 370413 0
pre-treatment, 3, 6, 12, 24 months, and 5 years post diagnosis or definitive treatment.
Secondary outcome [9] 370414 0
Western Ontario Rotator Cuff Scale (WORC) [Rotator cuff cohort only]
Timepoint [9] 370414 0
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
7 Years
Maximum age
No limit
Gender
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 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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26102 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 302319 0
Self funded/Unfunded
Name [1] 302319 0
Mr Kevin Eng
Address [1] 302319 0
Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220
Country [1] 302319 0
Australia
Funding source category [2] 302686 0
Other Collaborative groups
Name [2] 302686 0
Geelong Orthopaedics
Address [2] 302686 0
Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220
Country [2] 302686 0
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] 302199 0
None
Name [1] 302199 0
Address [1] 302199 0
Country [1] 302199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302992 0
Barwon Health HREC
Ethics committee address [1] 302992 0
PO Box 281
Geelong VIC 3220
Ethics committee country [1] 302992 0
Australia
Date submitted for ethics approval [1] 302992 0
09/05/2019
Approval date [1] 302992 0
19/07/2019
Ethics approval number [1] 302992 0
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 92098 0
Dr Kevin Eng
Address 92098 0
Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220
Country 92098 0
Australia
Phone 92098 0
+61352226602
Fax 92098 0
Email 92098 0
kevineng@geelongortho.com.au
Contact person for public queries
Name 92099 0
Dr Kevin Eng
Address 92099 0
Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220
Country 92099 0
Australia
Phone 92099 0
+61352226602
Fax 92099 0
Email 92099 0
kevineng@geelongortho.com.au
Contact person for scientific queries
Name 92100 0
Dr Kevin Eng
Address 92100 0
Geelong Orthopaedics; 2/83-85 Myers St, Geelong VIC 3220
Country 92100 0
Australia
Phone 92100 0
+61352226602
Fax 92100 0
Email 92100 0
kevineng@geelongortho.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
IPD contains confidential information
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5699 0
Ethical approval
Citation [1] 5699 0
Link [1] 5699 0
Email [1] 5699 0
kengadmin@geelongortho.com.au
Other [1] 5699 0
Attachment [1] 5699 0
Type [2] 5700 0
Study protocol
Citation [2] 5700 0
Link [2] 5700 0
Email [2] 5700 0
kengadmin@geelongortho.com.au
Other [2] 5700 0
Attachment [2] 5700 0
Type [3] 5701 0
Statistical analysis plan
Citation [3] 5701 0
Link [3] 5701 0
Email [3] 5701 0
kengadmin@geelongortho.com.au
Other [3] 5701 0
Attachment [3] 5701 0
Type [4] 5702 0
Informed consent form
Citation [4] 5702 0
Link [4] 5702 0
Email [4] 5702 0
kengadmin@geelongortho.com.au
Other [4] 5702 0
Attachment [4] 5702 0
Summary results
No Results