Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001350617
Ethics application status
Approved
Date submitted
26/11/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of Acellular Human Dermal Allograft Patch for Augmentation of Rotator Cuff Repair - A Randomised Controlled Trial
Scientific title
Efficacy of Acellular Human Dermal Allograft Patch in Improving Shoulder Function following Rotator Cuff Repair - A Randomised Controlled Trial
Secondary ID [1] 311023 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tear 332140 0
Condition category
Condition code
Musculoskeletal 328863 328863 0 0
Other muscular and skeletal disorders
Surgery 328998 328998 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of an allopatch augmentation graft by an consultant orthopaedic surgeon in surgical rotator cuff repair. The graft is an acellular dermal allopatch graft that has been treated and suitable for surgery. It theoretically provides a mechanical bridge to aid in the strength of the repair. This will occur as an additional step during an arthroscopic repair of the rotator cuff at a certified hospital to repair the rotator cuff that adds roughly an extra 20 minutes and overall takes 1.5-2h to complete the surgery.
Intervention code [1] 327473 0
Treatment: Devices
Comparator / control treatment
Comparator group will receive a surgical repair without the allograft.
Control group
Active

Outcomes
Primary outcome [1] 336673 0
Functional shoulder outcome following surgical repair of rotator cuff
Timepoint [1] 336673 0
6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation
Primary outcome [2] 336674 0
Functional shoulder outcome following surgical repair of rotator cuff
Timepoint [2] 336674 0
6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation
Primary outcome [3] 336884 0
Functional shoulder outcome following surgical repair of rotator cuff
Timepoint [3] 336884 0
6 weeks, 3 months, 6 months, 12 months, and 24 months post-operation
Secondary outcome [1] 429283 0
Adverse events such as pain, or infection.
Timepoint [1] 429283 0
6 weeks, 3, 6, 12, and 24 months post-operation
Secondary outcome [2] 430041 0
MRI assessment of rotator cuff
Timepoint [2] 430041 0
12 months post-operation

Eligibility
Key inclusion criteria
- Diagnosis of rotator cuff tear confirmed radiologically by MRI to be full-thickness, greater than or equal to 4cm, involve two or more tendons and be repairable.
- Adequate pre-operative function of the uninjured arm.
- Ability to understand and participate in the trial including ability to understand and complete the patient reported outcome measures (PROMs).
- Ability to participate in regular rehabilitation post-operatively.
- Age 18-75 years.
- Medically fit for surgery with general anaesthetic.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years or greater than 75 years.
- Any previous surgical repair to the injured shoulder
- Neuromuscular disorders (for example, myasthenia gravis, Lambert-Eaton, amyotrophic lateral sclerosis et cetera).
- Upper extremity dysfunction due to a neurological or medical cause (for example, due to a cerebrovascular accident or traumatic brain injury, diabetic neuropathy et cetera).
- Unfit for general anaesthesia.
- Evidence of active infection or cancer.
- Current smoker.
- Current use of immunosuppressing medication.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer app for patient hospital numbers.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/11/2023
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315285 0
Commercial sector/Industry
Name [1] 315285 0
MTF Biologics
Country [1] 315285 0
United States of America
Primary sponsor type
Hospital
Name
St. John of God Healthcare Subiaco
Address
12 Salvado Rd, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 317334 0
None
Name [1] 317334 0
Address [1] 317334 0
Country [1] 317334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314208 0
St. John of God Healthcare Human Ethics Research Committee
Ethics committee address [1] 314208 0
12 Salvado Rd, Subiaco WA 6008
Ethics committee country [1] 314208 0
Australia
Date submitted for ethics approval [1] 314208 0
24/07/2023
Approval date [1] 314208 0
07/08/2023
Ethics approval number [1] 314208 0

Summary
Brief summary
To compare whether use of a dermal allopatch graft in rotator cuff repair leads to improved functional and structural outcomes over a 2-year period compared to no graft. It is expected the use of these grafts will improve functional shoulder outcomes and reduce the re-tear rate following surgery. If successful these grafts can be potentially considered a gold standard of care moving forward. We will also be monitoring for any changes in adverse event profile.
Trial website
Trial related presentations / publications
.
Public notes

Contacts
Principal investigator
Name 130786 0
Dr William Blakeney
Address 130786 0
St. John of God Healthcare, 12 Salvado Road, Subiaco, WA, 6008
Country 130786 0
Australia
Phone 130786 0
+61 404848114
Fax 130786 0
Email 130786 0
blakeney@gmail.com
Contact person for public queries
Name 130787 0
Dr William Blakeney
Address 130787 0
St. John of God Healthcare, 12 Salvado Road, Subiaco, WA, 6008
Country 130787 0
Australia
Phone 130787 0
+61 404848114
Fax 130787 0
Email 130787 0
blakeney@gmail.com
Contact person for scientific queries
Name 130788 0
Dr William Blakeney
Address 130788 0
St. John of God Healthcare, 12 Salvado Road, Subiaco, WA, 6008
Country 130788 0
Australia
Phone 130788 0
+61 404848114
Fax 130788 0
Email 130788 0
blakeney@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via journal/website of publication.


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.