Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000480482
Ethics application status
Not yet submitted
Date submitted
5/09/2007
Date registered
21/09/2007
Date last updated
21/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Arthroscopic Treatment of Painful Snapping of the Scapula by using a New Superior Portal
Scientific title
Arthroscopic Treatment of Painful Snappingof the Scapula by using a New Superior Portal
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 2325 0
Painful snapping scapula 2327 0
Condition category
Condition code
Musculoskeletal 2428 2428 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arthroscopic surgery of the scapula using a new superior portal for an established operative procedure. Single surgical procedure < 1 hour duration on one occasion only
Intervention code [1] 2044 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3334 0
Safety, ease and better access and visualisation to allow resection of the superomedial corner of the scapula
Timepoint [1] 3334 0
Single operative procedure and follow up average of 11.5 months
Secondary outcome [1] 5547 0
Reduction in pre-operative pain (VAS 0-10), the time to return to work and previous sporting activity
Timepoint [1] 5547 0
average 11.5 months followup

Eligibility
Key inclusion criteria
Painful snapping scapula (>12 months) who failed adequate conservative treatment : non steroidal anti-inflammatory drugs (NSAIDS); local injection of corticosteroids and physiotherapy with scapular adduction and postural shoulder shrug exercises.
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bony abnormalities

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All patients had a diagnosis of painful snapping scaplua, confirmed by clinical examination, a normal plain X-Ray and MRI excluding bony abnormalities.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 257 0
3186

Funding & Sponsors
Funding source category [1] 2588 0
Self funded/Unfunded
Name [1] 2588 0
Country [1] 2588 0
Funding source category [2] 2589 0
Self funded/Unfunded
Name [2] 2589 0
Country [2] 2589 0
Primary sponsor type
Individual
Name
Simon Bell
Address
Melbourne Shoulder and Elbow Centre
Brighton Orthopaedic Clinic
31 Normanby St.,
Brighton 3186,
Victoria
Country
Australia
Secondary sponsor category [1] 2340 0
None
Name [1] 2340 0
Address [1] 2340 0
Country [1] 2340 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4510 0
Ethics committee address [1] 4510 0
Ethics committee country [1] 4510 0
Date submitted for ethics approval [1] 4510 0
01/01/2007
Approval date [1] 4510 0
Ethics approval number [1] 4510 0

Summary
Brief summary
Pain and crepitus (a scraping feel and sound) can occur at the scapula (shoulder blade) restricting the shoulder's normal gliding motion. Previous studies have shown that removing a small supero medial portion of the scapula bone can correct this. This can be done arthroscopically (key hole surgery) but this area is difficult to see and access. We have previously published an article on anatomic studies demonstrating a safe new 'key hole' position which allows experienced arthroscopists better access to enable removal of the 'troublesome' bone. In this study we evaluated the outcome of patients who had this procedure with regard to their good and excellent return to work and sport. All patients thought it was worthwhile having the operation.
Trial website
Trial related presentations / publications
Published.
Attila Pavlik, Kian Ang, Jennifer Coghlan, Simon Bell."Arthroscopic Treatment of Painful Snapping of the Scapula by Using a New Superior Portal
Arthroscopy, Vol 19, No.6 (July-August), 2003 pp 608-612
Public notes

Contacts
Principal investigator
Name 28026 0
Address 28026 0
Country 28026 0
Phone 28026 0
Fax 28026 0
Email 28026 0
Contact person for public queries
Name 11183 0
Jennifer Coghlan
Address 11183 0
Melbourne Shoulder and Elbow Centre
Brighton Orthopaedic Clinic
31 Normanby St.,
Brighton 3186,
Victoria
Country 11183 0
Australia
Phone 11183 0
+61 3 95928028
Fax 11183 0
+61 3 95929612
Email 11183 0
[email protected]
Contact person for scientific queries
Name 2111 0
Simon Bell
Address 2111 0
Melbourne Shoulder and Elbow Centre
Brighton Orthopaedic Clinic
31 Normanby St.,
Brighton 3186,
Victoria
Country 2111 0
Australia
Phone 2111 0
+61 3 95928028
Fax 2111 0
Email 2111 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.