Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000196549
Ethics application status
Approved
Date submitted
20/05/2006
Date registered
26/05/2006
Date last updated
30/03/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of two alternative suture anchors, Panalok and bioraptor 2.3 for primary stabilisation of the shoulder for instability and identification of risk factors for recurrence of the shoulder instability post operation
Scientific title
The efficacy of 2 alternative suture materials Ethibond and Panacryl used with Panalok 'suture anchors' for the primary open surgical stabilisation of the shoulder for instability - a double blind randomised trial
Secondary ID [1] 281634 0
nil
Universal Trial Number (UTN)
Trial acronym
Anchor stabilisation study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder stabilisation: shoulder instability episodes not controlled with conservative measures 1172 0
Condition category
Condition code
Musculoskeletal 1256 1256 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Panalok suture anchors with either a bioabsorbable suture (panacryl) or non- absorbable suture (ethibond) used during open surgical stabilisation of the shoulder for instability.
Intervention code [1] 286171 0
Treatment: Surgery
Comparator / control treatment
Use of Panalok suture anchors with either a bioabsorbable suture (panacryl) or non- absorbable suture (ethibond) used during open surgical stabilisation of the shoulder for instability
Control group
Active

Outcomes
Primary outcome [1] 1694 0
Our hypothesis is that there is no difference in outcome between panacryl and ethibond suture material when used for this procedure in which case the panacryl may be theoretically better as it dissolves away completely.
Timepoint [1] 1694 0
This is assessed at 2 weeks, 12 weeks, 6 , 12 and 24 months.
Secondary outcome [1] 3037 0
Identification of risk factors for recurrent instability post operatively.
Timepoint [1] 3037 0
Assesed at 12 and 24 months post operation.

Eligibility
Key inclusion criteria
Informed consent. Requiring anterior shoulder stabilisation.
Minimum age
16 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous stabilisation surgery to this shoulder.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6112 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 1371 0
Self funded/Unfunded
Name [1] 1371 0
A/Professor Simon Bell, FRCS,FRACS,FAOrthA, PhD
Country [1] 1371 0
Australia
Funding source category [2] 1372 0
Commercial sector/Industry
Name [2] 1372 0
DePuy- Mitek
Country [2] 1372 0
Australia
Funding source category [3] 1373 0
Commercial sector/Industry
Name [3] 1373 0
Smith and Nephew Surgical
Country [3] 1373 0
Australia
Primary sponsor type
Individual
Name
Simon BELL
Address
A/Professor Simon Bell
Melbourne Shoulder and Elbow Centre
31 Normanby St.,
Brighton 3186
Country
Australia
Secondary sponsor category [1] 1210 0
None
Name [1] 1210 0
Nil
Address [1] 1210 0
Country [1] 1210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2728 0
Mercy aged and Health Care and Monash University HREC
Ethics committee address [1] 2728 0
Ethics committee country [1] 2728 0
Australia
Date submitted for ethics approval [1] 2728 0
Approval date [1] 2728 0
22/05/2006
Ethics approval number [1] 2728 0
R06/06P and CF10/0376

Summary
Brief summary
During stabilisation of the shoulder which has been unstable (dislocated) the surgeon attaches back the damaged ligament to the bone with a 'Panalok" suture anchor. This is tied into place with a separate suture made of either panacryl which dissolves or ethibond which does not. The hypothesis is that there is no differenvce between the sutures but the bioabsorbable (dissolving) suture theoretically should be preferred because is disolves away completed and reduces the risk of foreign body reactions.
The sutures are dyed the same colour so the surgeon, the patient , the ward staff and outcome assessors are blinded
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35545 0
A/Prof Simon Bell
Address 35545 0
Monash University Dept. of Surgery
Melbourne Shoulder and Elbow Centre,
31 Normanby St.
Brighton VIC 3186
Country 35545 0
Australia
Phone 35545 0
+ 61 3 95923775
Fax 35545 0
Email 35545 0
[email protected]
Contact person for public queries
Name 10247 0
Dr Jennifer Coghlan
Address 10247 0
Monash University Dept. of Surgery
Melbourne Shoulder and Elbow Centre,
31 Normanby St.
Brighton VIC 3186
Country 10247 0
Australia
Phone 10247 0
+61 3 95928028
Fax 10247 0
+61 3 95929612
Email 10247 0
[email protected] au
Contact person for scientific queries
Name 1175 0
A/Prof Simon Bell
Address 1175 0
Melbourne Shoulder and Elbow Centre
31 Normanby St.
Brighton VIC 3186
Country 1175 0
Australia
Phone 1175 0
+61 3 95923775
Fax 1175 0
+61 3 95921486
Email 1175 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
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