Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000194561
Ethics application status
Approved
Date submitted
20/05/2006
Date registered
24/05/2006
Date last updated
24/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The validity and reliability of the University of California,Los Angeles (UCLA) shoulder score for use as a self assessment postal questionnaire in patients following rotator cuff surgery to assess outcome
Scientific title
The validity and reliability of the University of California, Los Angeles (UCLA) shoulder score for use as a self assessment postal questionnaire in post rotator cuff surgery assessment.
Universal Trial Number (UTN)
Trial acronym
'UCLA'
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post rotator cuff surgery assessment 1170 0
Condition category
Condition code
Musculoskeletal 1254 1254 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The UCLA questionnaire is completed by the patient at home within 24 hours of attending for a post operative appointment and handed in a sealed opaque envelope to a receptionist and stored unopened until data entry. This takes the patient 5-10 minutes. Separately and in computer generated random order the patient is physically assessed by 2 outcome assessors in separate rooms and separate UCLA forms are completed by each assessor , sealed in opaque envelopes and stored separately until data entry is commenced. These forms are completed at 2 months following subacromial decompression and 4 months following rotator cuff repair.
Intervention code [1] 1060 0
Rehabilitation
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1692 0
Inter class correlation of the validity and reliability of this tool as a self assessment tool between patient and assessor one and assessor two
Timepoint [1] 1692 0
At 2 months following subacromial decompression and 4 months following rotator cuff repair.
Secondary outcome [1] 3034 0
Nil
Timepoint [1] 3034 0

Eligibility
Key inclusion criteria
Informed consent.Assessment at 2 months after subacromial decompression.At 4 months after rotator cuff repair.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not having had rotator cuff surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In random allocation order patients were placed in one of two assessment rooms by a person unconnected with the study .placed Completed forms stored separately by a person not involved in the study in sealed opaque envelopes until data entry
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1368 0
Commercial sector/Industry
Name [1] 1368 0
Simon Bell's rooms at Melbourne Shoulder and Elbow Centre
Country [1] 1368 0
Australia
Primary sponsor type
Individual
Name
Simon Bell
Address
Country
Secondary sponsor category [1] 1208 0
Individual
Name [1] 1208 0
Jennifer Coghlan
Address [1] 1208 0
Country [1] 1208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2724 0
Mercy Private Hospital
Ethics committee address [1] 2724 0
Ethics committee country [1] 2724 0
Australia
Date submitted for ethics approval [1] 2724 0
Approval date [1] 2724 0
14/01/2004
Ethics approval number [1] 2724 0
RPO/45P
Ethics committee name [2] 2725 0
Linacre Private Hospital
Ethics committee address [2] 2725 0
Ethics committee country [2] 2725 0
Australia
Date submitted for ethics approval [2] 2725 0
Approval date [2] 2725 0
20/01/2004
Ethics approval number [2] 2725 0
2003/905MC

Summary
Brief summary
The UCLA shoulder score is used to asess the outcome of rotator cuff surgery in the shoulder. Currently this score is assessed clinically- requiring patients to attend for a doctor's appointment. The hypothesis is that with adequate instruction the patient could complete this form at home and this would increase participation in studies which may follow up patients 10 years later. These patients would not have to travel long distances for a clinical assessment for research purposes only. Patients, assessors 1 & 2 are blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35196 0
Address 35196 0
Country 35196 0
Phone 35196 0
Fax 35196 0
Email 35196 0
Contact person for public queries
Name 10249 0
Jennifer Coghlan
Address 10249 0
Brighton Orthopaedic Clinic
31 Normanby St.
Brighton VIC 3186
Country 10249 0
Australia
Phone 10249 0
+61 3 95928028
Fax 10249 0
+61 3 95921486
Email 10249 0
[email protected]
Contact person for scientific queries
Name 1177 0
Simon Bell
Address 1177 0
Melbourne Shoulder and Elbow Centre
31 Normanby St.
Brighton VIC 3186
Country 1177 0
Australia
Phone 1177 0
+61 3 95923775
Fax 1177 0
+61 3 95929612
Email 1177 0
[email protected]

No information has been provided regarding IPD availability


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.