Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000366651
Ethics application status
Approved
Date submitted
24/03/2014
Date registered
7/04/2014
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Date results provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a tight posterior capsule using a 4-Dimensional Computed Tomography scanner
Scientific title
Assessment of the Movement of the Acromioclavicular (AC) Joint by the 4-Dimensoinal Computed Tomography (4D CT) Scanner when Stressed and Forced to Sublux by Tension Being Placed on a Tight Glenohumeral Posterior Capsule
Secondary ID [1] 284316 0
Nil known
Universal Trial Number (UTN)
Trial acronym
4D CT TPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tight Posterior Capsule 291465 0
Shoulder Pain 291466 0
Condition category
Condition code
Musculoskeletal 291834 291834 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves scanning with a 4D CT scanner volunteers and patients with tight posterior capsules to assess the movement of the shoulder joint while being stressed. The intervention group will require an examination, a demographics questionnaire and scan.


The examination will involve the participant being examined by the chief investigator and will involve a few different measurements and tests to assess shoulder function. These measurements will involve the participant moving their arm to demonstrate range of motion and a few clinical tests to determine the presence of pathology. This examination should take approximately 5-10 minutes to complete. The examination will be completed on a day convenient for the participant before the 4D CT scan.

The 4D CT scan involves exposure to a very small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation. The dose of radiation you will receive from the CT scan is comparable to that received from many diagnostic x-ray and nuclear medicine procedures. At this dose level, no harmful effects of radiation have been demonstrated, as any effect is too small to measure, and the risk is believed to be low. The scan should take no longer than 7 seconds and the dose has been determined to be ~10mSv. Only one scan of the affected/ volunteered shoulder is required per participant.

During the scan, the participant's shoulder will be required to complete a specific movement which will show how the shoulder moves. The movement will involve placing the patients arm in abduction and internally rotating the arm until maximum range of motion has been achieved or the patient is unable to proceed any further without distress.

Protective shields may be worn and the protocol of the Department of Radiology where the scans will be conducted will be adhered to.
Intervention code [1] 289037 0
Diagnosis / Prognosis
Comparator / control treatment
The control group being used is a group of volunteers who have normal shoulders. The baseline for patients with normal shoulders in a 4D CT scanner has yet to have been established, hence it is important to scan volunteers who have normal shoulders. The control group will be required to complete an examination, questionnaire and scan of their shoulder like the intervention group.

The 4D CT scan involves exposure to a very small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation. The dose of radiation you will receive from the CT scan is comparable to that received from many diagnostic x-ray and nuclear medicine procedures. At this dose level, no harmful effects of radiation have been demonstrated, as any effect is too small to measure, and the risk is believed to be low. The scan should take no longer than 7 seconds and the dose has been determined to be ~10mSv. Only one scan of the affected/ volunteered shoulder is required per participant.

Protective shields may be worn and the protocol of the Department of Radiology where the scans will be conducted will be adhered to.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291752 0
The primary outcome being measured is to study the relationship between tight posterior capsules and shoulder movement. This is best done by the 4D CT scanner to capture the relationship of the landmarks of the shoulder joint as it is stressed.
Timepoint [1] 291752 0
Once consent for the project has been achieved, a questionnaire will be provided and an examination of the participants will be conducted. Once this has been completed, a 4D CT scan will be performed when possible.
Secondary outcome [1] 307413 0
The secondary outcome is aiming to establish baseline data for the posterior capsule. A baseline has not yet been established in current literature therefore, there is currently nothing to compare the data to.
Timepoint [1] 307413 0
Baseline

Eligibility
Key inclusion criteria
There are two study groups involved in this project;

Patients include in the participant group will be determined to have tight posterior capsules as determined by the senior chief investigator. The chief investigator will examine each participant manually.

There are also a group of volunteer that will have heavy shoulders with no shoulder problems. A demographics questionnaire and an examination by the chief investigator will be conducted on these volunteers to ensure that this group is eligible for the study.

Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Language difficulties that do not allow consent to be completed, arthritic changes on X-ray, pregnant women, those who are unable to perform the required movement for the scanner, reparative surgery to capsule for rotator cuffs

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will need to complete a questionnaire and be examined to determine if they are eligible for the study. Once the procedure is completed, a 4D CT scan will be performed to establish a baseline which has not yet been established in the current literature.

Participants will be classified and examined by the chief principal investigator who will determine if they are eligible for the participant group. They will then receive a 4D CT scan to analyse how a tight posterior capsule effects the movement of the shoulder.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a convenience sample. Once we have established what the ‘normal AC joint tight posterior capsule’ relationship is using 20 volunteers- we will use a convenience sample of patients with the clinical diagnosis.

This convenience sample of 20 has been used before in a paper presented at the SECEC- ESSSE Conference in Dubrovnik 19th-22nd September 2012 (The new 4D CT scanner allows dynamic visualization and measurement of normal acromioclavicular joint motion Tjarco Alta, Jennifer Coghlan, Simon Bell)

No statistical assumptions- however a statistician has advised that 20 would be sufficient to establish a ‘normal’ pattern of movement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2014
Actual
14/04/2014
Date of last participant enrolment
Anticipated
31/12/2016
Actual
16/08/2017
Date of last data collection
Anticipated
Actual
16/09/2017
Sample size
Target
40
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288956 0
Self funded/Unfunded
Name [1] 288956 0
Associate Professor Simon Bell
Country [1] 288956 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Simon Bell
Address
Melbourne Shoulder and Elbow Centre
31 Normanby St, Brighton VIC 3186
Country
Australia
Secondary sponsor category [1] 287664 0
None
Name [1] 287664 0
Address [1] 287664 0
Country [1] 287664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290767 0
Monash Health HREC
Ethics committee address [1] 290767 0
Ethics committee country [1] 290767 0
Australia
Date submitted for ethics approval [1] 290767 0
20/02/2014
Approval date [1] 290767 0
11/04/2014
Ethics approval number [1] 290767 0
14034B
Ethics committee name [2] 294297 0
Monash University HREC
Ethics committee address [2] 294297 0
Ethics committee country [2] 294297 0
Australia
Date submitted for ethics approval [2] 294297 0
Approval date [2] 294297 0
16/04/2014
Ethics approval number [2] 294297 0
CF14/1214 – 2014000545

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47186 0
A/Prof Simon Bell
Address 47186 0
Melbourne Shoulder and Elbow Centre 31 Normanby St., Brighton 3186, Victoria
Country 47186 0
Australia
Phone 47186 0
61 3 95923775
Fax 47186 0
61 3 95929612
Email 47186 0
[email protected]
Contact person for public queries
Name 47187 0
Jennifer Coghlan
Address 47187 0
Melbourne Shoulder and Elbow Centre 31 Normanby St., Brighton 3186, Victoria
Country 47187 0
Australia
Phone 47187 0
61 3 95923775
Fax 47187 0
61 3 95929612
Email 47187 0
[email protected]
Contact person for scientific queries
Name 47188 0
Jennifer Coghlan
Address 47188 0
Melbourne Shoulder and Elbow Centre 31 Normanby St., Brighton 3186, Victoria
Country 47188 0
Australia
Phone 47188 0
61 3 95923775
Fax 47188 0
61 3 95929612
Email 47188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no data dictionaries


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23325Ethical approval    366032-(Uploaded-27-05-2021-15-39-00)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisNo

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
658ThesisNo In house presentation Monash University Department... [More Details]

Documents added automatically
No additional documents have been identified.