Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001223527
Ethics application status
Not required
Date submitted
3/11/2015
Date registered
9/11/2015
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes Following Open Surgical Repair for the Treatment of Recurrent Shoulder Instability in Patients 20 Years and Younger
Scientific title
In patients 20 years or younger with recurrent shoulder instability, does open surgical repair, produce good functional outcome and low rates of recurrence?
Secondary ID [1] 287775 0
Nil Known
Universal Trial Number (UTN)
U1111-1176-1121
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Instability 296661 0
Condition category
Condition code
Surgery 296885 296885 0 0
Surgical techniques
Musculoskeletal 296939 296939 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
This will be an audit of patients 20 years or younger who have undergone open surgical repair of their recurrent shoulder instability. It will be assessed via a self administered questionnaire.
Intervention code [1] 293168 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296487 0
Recurrent shoulder instability - this will be assessed by a self administered questionnaire mailed out to patients. This is a questionnaire which has been designed specifically for the study, and includes the Western Ontario Shoulder Instability Score as part of it
Timepoint [1] 296487 0
This will be assessed only once via a questionnaire, at least 2 years after surgery.
Primary outcome [2] 296488 0
Western Ontario Shoulder Instability Score
Timepoint [2] 296488 0
This will be assessed only once via a questionnaire, at least 2 years after surgery.
Secondary outcome [1] 318590 0
Ability to return to previous level of physical activity. This will be assessed via a self-administered questionnaire.. This is a questionnaire which has been designed specifically for the study, and includes the Western Ontario Shoulder Instability Score as part of it
Timepoint [1] 318590 0
This will be assessed only once via a questionnaire, at least 2 years after surgery.

Eligibility
Key inclusion criteria
Patients 20 years or younger who have undergone open surgical repair for shoulder instability, at least 2 years before
Minimum age
14 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This is an audit of our practice, with a database of 115 eligible patients who have undergone open surgical repair in the last 6 years, and so we will aim to follow up all of these patients who want to participate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2015
Actual
7/12/2015
Date of last participant enrolment
Anticipated
1/08/2018
Actual
Date of last data collection
Anticipated
1/10/2018
Actual
Sample size
Target
115
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 7287 0
New Zealand
State/province [1] 7287 0

Funding & Sponsors
Funding source category [1] 292311 0
Other
Name [1] 292311 0
UniSports Sports Medicine
Country [1] 292311 0
New Zealand
Primary sponsor type
Other
Name
UniSports Sports Medicine
Address
71 Merton Road
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 290991 0
None
Name [1] 290991 0
none
Address [1] 290991 0
none
Country [1] 290991 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 293784 0
Ethics committee address [1] 293784 0
Ethics committee country [1] 293784 0
New Zealand
Date submitted for ethics approval [1] 293784 0
11/11/2015
Approval date [1] 293784 0
Ethics approval number [1] 293784 0

Summary
Brief summary
This study will be an audit of our surgical practices. A short questionnaire will be mailed out to patients who meet the inclusion criteria, that they can choose to fill out in their own time. Males who are under 25 are considered a high risk subgroup for post-operative recurrence of their shoulder instability, and so there is some suggestion that this high risk group of patients should undergo open surgical repair due to its association with lower rates of recurrence. This audit aims to look at our own recurrence rates in patients 20 years or younger who have had open surgical repair., and their functional outcomes, assessed via the WOSI score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61294 0
Miss Grace Gatenby
Address 61294 0
UniSports Sports Medicine
71 Merton Road
Auckland 1072
New Zealand
Country 61294 0
New Zealand
Phone 61294 0
+64 2040062400
Fax 61294 0
Email 61294 0
ggat562@aucklanduni.ac.nz
Contact person for public queries
Name 61295 0
Miss Grace Gatenby
Address 61295 0
UniSports Sports Medicine
71 Merton Road
Auckland 1072
New Zealand
Country 61295 0
New Zealand
Phone 61295 0
+64 2040062400
Fax 61295 0
Email 61295 0
ggat562@aucklanduni.ac.nz
Contact person for scientific queries
Name 61296 0
Miss Grace Gatenby
Address 61296 0
UniSports Sports Medicine
71 Merton Road
Auckland 1072
New Zealand
Country 61296 0
New Zealand
Phone 61296 0
+64 2040062400
Fax 61296 0
Email 61296 0
ggat562@aucklanduni.ac.nz

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.