Trial Review

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
ACTRN12616000183482
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
12/02/2016
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biceps strength following Latarjet procedure for shoulder stabilisation
Scientific title
Biceps strength in adult males following the Latarjet procedure
Secondary ID [1] 286639 0
nil
Universal Trial Number (UTN)
U1111-1169-8645
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Instability 294963 0
Rehabilitation Post Shoulder Surgery 294964 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295224 295224 0 0
Other physical medicine / rehabilitation
Surgery 295226 295226 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of biceps strength (elbow supination and flexion) using a Biodex dynamometer 12months following transfer of the short head of biceps origin as part of the routine Latarjet procedure. This will be compared to a preoperative measurement.
Intervention code [1] 293573 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297001 0
biceps strength using Biodex dynamometer
Timepoint [1] 297001 0
12 months post completion of Latarjet procedure
Secondary outcome [1] 319825 0
subscapularis strength using biodex dynamometer
Timepoint [1] 319825 0
12 months post completion of Latarjet procedure
Secondary outcome [2] 319826 0
shoulder function using clinical scores (oxford and DASH scores)
Timepoint [2] 319826 0
12 months post latarjet procedure completion

Eligibility
Key inclusion criteria
adult male undergoing Latarjet procedure for shoulder instability
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
inability to understand study requirements, non-english speakers.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
sample size of 10 based upon power calculation (power value of 0.8) to detect a difference (effect size) of 10% before and after surgery.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5014 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 5015 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 292658 0
Self funded/Unfunded
Name [1] 292658 0
michael perret
Country [1] 292658 0
Australia
Primary sponsor type
Individual
Name
Michael Perret
Address
c/o Orthopaedic dept, sir charles gairdner hospital, hospital ave, nedlands WA, 6009
Country
Australia
Secondary sponsor category [1] 291376 0
None
Name [1] 291376 0
Address [1] 291376 0
Country [1] 291376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294131 0
sir charles gairdner
Ethics committee address [1] 294131 0
Dept of Research,
Sir Charles Gairdner Hospital,
Hospital ave,
Nedlands,
WA, 6009
Ethics committee country [1] 294131 0
Australia
Date submitted for ethics approval [1] 294131 0
Approval date [1] 294131 0
28/04/2015
Ethics approval number [1] 294131 0
2015-016

Summary
Brief summary
The purpose of this study is to investigate whether the Latarjet surgical procedure causes any detectable change in the strength of the biceps muscle post-operatively. If you agree to participate in the study, an appointment will be arranged for you to attend for a preoperative biceps strength test (about 15mins duration) at the University of Western Australia. This will involve taking measurements from a resistance machine similar to gym equipment which records your strength. We will also give you a short questionnaire on your shoulder function for you to complete which will take about 10-15 minutes. Your surgery and rehabilitation will not be affected.
After 12 months have passed we will contact you by telephone to arrange a time for you to come in and repeat the strength test and questionnaire to see whether your biceps strength and shoulder function have changed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56982 0
Dr michael perret
Address 56982 0
Orthopaedic Dept,
Sir Charles Gairdner Hospital,
Hospital ave,
Nedlands WA, 6009
Country 56982 0
Australia
Phone 56982 0
+61 8 9364 3333
Fax 56982 0
+61 8 9364 3333
Email 56982 0
[email protected]
Contact person for public queries
Name 56983 0
Dr michael perret
Address 56983 0
Orthopaedic Dept,
Sir Charles Gairdner Hospital,
Hospital ave,
Nedlands WA, 6009
Country 56983 0
Australia
Phone 56983 0
+61 8 9364 3333
Fax 56983 0
Email 56983 0
[email protected]
Contact person for scientific queries
Name 56984 0
Dr michael perret
Address 56984 0
Orthopaedic Dept,
Sir Charles Gairdner Hospital,
Hospital ave,
Nedlands WA, 6009
Country 56984 0
Australia
Phone 56984 0
+61 8 9364 3333
Fax 56984 0
Email 56984 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.