Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000944831
Ethics application status
Not yet submitted
Date submitted
4/09/2012
Date registered
4/09/2012
Date last updated
4/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of open surgery versus arthroscopic surgery for resection of the acromioclavicular (AC) joint.
Scientific title
A comparison of post-operative and functional outcomes of arthroscopic versus open resection of the acromioclavicular joint: A prospective, randomized study.
Secondary ID [1] 281158 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis of the acromioclavicular joint 287323 0
Condition category
Condition code
Musculoskeletal 287658 287658 0 0
Osteoarthritis
Surgery 287665 287665 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resection of the Acromioclavicular joint involves removal of the distal 8-10mm of the lateral clavicle to treat arthritis of the acromioclavicular joint. The resection can either be performed as an open procedure or via arthroscopic surgery. Both procedures are permanent and have a duration of 45 minutes.
Intervention code [1] 285605 0
Treatment: Surgery
Comparator / control treatment
Open resection of the Acromioclavicular joint involves removal of the distal 8-10mm of the lateral clavicle to treat arthritis of the acromioclavicular joint. The procedure is permanent and the procedure duration is 45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287904 0
Oxford shoulder score
Timepoint [1] 287904 0
3 months, six months, one year, two years
Secondary outcome [1] 299030 0
Disability of Arm, Shoulder, Hand (DASH) score
Timepoint [1] 299030 0
3 months, 6 months, 12 months, 2 years

Eligibility
Key inclusion criteria
Patients undergoing resection of the acromioclavicular joint for arthritis
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
dislocation of AC joint, infection, tumor, rotator cuff disease, labral injuries

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)
Patients placed on waiting list for resection of the acromioclavicular joint at the participating hospital are eligible. Discussion will occur at initial appointment then the patient will be provided with an information sheet. Confirmation will occur at pre-admission. Randomisation performed by statistician and sealed envelopes opened at the time of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block permutation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4529 0
New Zealand
State/province [1] 4529 0

Funding & Sponsors
Funding source category [1] 285931 0
Self funded/Unfunded
Name [1] 285931 0
Brendan Coleman
Country [1] 285931 0
New Zealand
Primary sponsor type
Individual
Name
Brendan Coleman
Address
Dept of Orthopaedic Surgery
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 284760 0
None
Name [1] 284760 0
Address [1] 284760 0
Country [1] 284760 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287966 0
Health and Disability Ethics Committee Northern A
Ethics committee address [1] 287966 0
Ministry of Health
HDEC
PO Box 5013
Wellington 6011
Ethics committee country [1] 287966 0
New Zealand
Date submitted for ethics approval [1] 287966 0
15/09/2012
Approval date [1] 287966 0
Ethics approval number [1] 287966 0

Summary
Brief summary
The study aims to assess the hypothesis that arthroscopic surgery results in an improved functional outcome with less pain than open surgery for resection of the acromioclavicular (AC) joint.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34660 0
Address 34660 0
Country 34660 0
Phone 34660 0
Fax 34660 0
Email 34660 0
Contact person for public queries
Name 17907 0
Brendan Coleman
Address 17907 0
Dept of Orthopaedic Surgery
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Private Bag 93311
Otahuhu
Auckland 1640
Country 17907 0
New Zealand
Phone 17907 0
+6492760000
Fax 17907 0
Email 17907 0
[email protected]
Contact person for scientific queries
Name 8835 0
Brendan Coleman
Address 8835 0
Dept of Orthopaedic Surgery
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Private Bag 93311
Otahuhu
Auckland 1640
Country 8835 0
New Zealand
Phone 8835 0
+6492760000
Fax 8835 0
Email 8835 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.