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Trial registered on ANZCTR


Registration number
ACTRN12612000943842
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 between treatments of the biceps tendon during shoulder replacement
Scientific title
A comparison of post-operative and functional outcomes following biceps tenodesis versus tenotomy in patients undergoing anatomic shoulder joint replacement surgery: A prospective, randomized study.
Secondary ID [1] 281155 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 shoulder 287321 0
Condition category
Condition code
Musculoskeletal 287656 287656 0 0
Osteoarthritis
Surgery 287664 287664 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biceps tenodesis is a procedure where the long head of biceps tendon is sutured into the biciptal groove to allow healing of the tendon into the groove. This results in a permanent healing of the tendon into the groove. Total shoulder replacement takes 120 minutes whilst the biceps tenodesis takes 5 minutes.
Intervention code [1] 285604 0
Treatment: Surgery
Comparator / control treatment
Biceps tenotomy is a procedure where the long head of biceps tendon is divided in its intra-articular position and allowed to slide in the bicipital groove and scar in a self determined position. This procedure is permanent. Total shoulder replacement takes 120 minutes whilst biceps tenotomy takes 1 minute.
Control group
Active

Outcomes
Primary outcome [1] 287902 0
Oxford shoulder score
Timepoint [1] 287902 0
6 months, 12 months, 2 years
Secondary outcome [1] 299027 0
Constant Shoulder score
Timepoint [1] 299027 0
6 months, 12 months, 2 years
Secondary outcome [2] 299028 0
Disability of Arm, Shoulder, Hand (DASH) score
Timepoint [2] 299028 0
6 months, 12 months, 2 years

Eligibility
Key inclusion criteria
Patients undergoing anatomic shoulder replacement
Minimum age
50 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tumour, fracture, cognitive impairment

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)
Subjects who are placed on waiting list for anatomic shoulder replacement at the participating hospital are eligible for enrollment. It will be discussed with patients at the initial clinic appointment then patients provided with information sheet. Confirmation of participation will occur at time of pre-admission. Randomisation will be performed by statistician and placed into sealed envelopes to be opened at the time of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization via computer
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
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4527 0
New Zealand
State/province [1] 4527 0

Funding & Sponsors
Funding source category [1] 285937 0
Self funded/Unfunded
Name [1] 285937 0
Brendan Coleman
Country [1] 285937 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] 284761 0
None
Name [1] 284761 0
Address [1] 284761 0
Country [1] 284761 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287956 0
Health and Disability Ethics Committee Northern A
Ethics committee address [1] 287956 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 287956 0
New Zealand
Date submitted for ethics approval [1] 287956 0
15/09/2012
Approval date [1] 287956 0
Ethics approval number [1] 287956 0

Summary
Brief summary
This study aims to compare biceps tenodesis to biceps tenotomy during shoulder replacement surgery. The hypothesis is that biceps tenodesis gives improvement in shoulder pain and function post-shoulder replacement.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34658 0
Address 34658 0
Country 34658 0
Phone 34658 0
Fax 34658 0
Email 34658 0
Contact person for public queries
Name 17905 0
Brendan Coleman
Address 17905 0
Dept of Orthopaedic Surgery
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Private Bag 93311
Otahuhu
Auckland 1640
Country 17905 0
New Zealand
Phone 17905 0
+6492760000
Fax 17905 0
Email 17905 0
[email protected]
Contact person for scientific queries
Name 8833 0
Brendan Coleman
Address 8833 0
Dept of Orthopaedic Surgery
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Private Bag 93311
Otahuhu
Auckland 1640
Country 8833 0
New Zealand
Phone 8833 0
+6492760000
Fax 8833 0
Email 8833 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.