Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001065583
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
13/10/2015
Date last updated
28/10/2022
Date data sharing statement initially provided
28/10/2022
Date results information initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of CelGro (R) Collagen Scaffold to Augment Surgical Repair of Rotator Cuff Tendinopathy and Tear.
Scientific title
Pilot Study of CelGro(R) Collagen Scaffold to Augment Surgical Repair of Rotator Cuff Tendinopathy and Tear.
Secondary ID [1] 287515 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tendinopathy 296274 0
Rotator Cuff Tear 296348 0
Condition category
Condition code
Musculoskeletal 296550 296550 0 0
Other muscular and skeletal disorders
Surgery 296681 296681 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are undergoing shoulder repair surgery will receive CelGro(R) which is implanted at the site of the tendinopathy or tear during surgery, by an Orthopaedic Surgeon, to provide an optimal environment for tissue repair.

This will be as part of the augmentation procedure instead of receiving normal surgical sutures to the damaged tendon. There is no cell collection or cultural procedures prior to surgery.

An Orthopaedic Surgon will place the collagen scaffold in place within the shoulder during surgery. The surgery itself will take approximately between 1 - 3 hours, this is a single occasion.
Intervention code [1] 292905 0
Treatment: Other
Intervention code [2] 292908 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296172 0
Measurement of tendon healing by MRI assessment.
Timepoint [1] 296172 0
6 and 12 months post-treatment.
Secondary outcome [1] 317690 0
Pain, assessed by VAS pain score.
Timepoint [1] 317690 0
3, 6 and 12 months post-treatment.
Secondary outcome [2] 317691 0
Symptoms assessed by OSS, CMS and ASES
Timepoint [2] 317691 0
3, 6, and 12 months post-treatment.

Eligibility
Key inclusion criteria
* Male or female between 40 and 70 years of age
* Symptomatic full-thickness supraspinatus and/or
infraspinatus tear >2cm, verified by MRI or ultrasound
imaging
* Able to comply with the requirements of the protocol,
including the post-treatment rehabilitation protocol, (this is
standard of care).
* Able to give informed consent or has legally acceptable
representative who can give informed consent in accordance
with ICH/GCP
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of clinically significant subchondral bone cyst
* Previous shoulder surgery or fracture
* Pathology of other rotator cuff or biceps tendons
* Glenohumeral or acromioclavicular osteoarthritis
* Evidence of calcification of affected tendon on screening MRI
* Active infection or systemic pathology including
inflammatory joint disease, HIV, uncontrolled or poorly
controlled diabetes, hepatitis or neoplastic disorders
* Neuromuscular disease of the affected arm
* Metabolic bone disorder which may impair bone or soft
tissue function
* Professional athlete
* Workers compensation case
* Known hypersensitivity to the study treatment or its
excipients or known relevant medication allergy
* Contraindicated to MRI
* Female participant who is pregnant or lactating
* Known substance abuse
* Participation in another study with an investigational
product within 3 months of the first planned study visit
* Concurrent medical condition which precludes the
administration of study treatment
* Other clinically significant disease (including psychological
disorders) or medical condition that would, in the opinion of
the Investigator, compromise the safety of the participant
or the outcome of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
30/11/2015
Actual
8/04/2016
Date of last participant enrolment
Anticipated
Actual
29/08/2017
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
30
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4373 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 4374 0
Mercy Hospital Mount Lawley - Mount Lawley
Recruitment hospital [3] 7757 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [4] 7758 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment postcode(s) [1] 10597 0
6008 - Subiaco
Recruitment postcode(s) [2] 10598 0
6050 - Mount Lawley
Recruitment postcode(s) [3] 15691 0
6150 - Murdoch
Recruitment postcode(s) [4] 15692 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 292089 0
Commercial sector/Industry
Name [1] 292089 0
Orthocell Ltd
Country [1] 292089 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd
Address
Building 191
Murdoch University
South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 290767 0
None
Name [1] 290767 0
Address [1] 290767 0
Country [1] 290767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293573 0
St John of God Health Care HREC
Ethics committee address [1] 293573 0
12 Salvado Road
Subiaco WA 6009
Ethics committee country [1] 293573 0
Australia
Date submitted for ethics approval [1] 293573 0
29/09/2015
Approval date [1] 293573 0
09/12/2015
Ethics approval number [1] 293573 0

Summary
Brief summary
The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Surgery is usually reserved for patients who fail to respond to conservative treatment.

Greater understanding of the cellular and molecular pathology of tendon injury led to the development of biological scaffolds to augment tendon repair. The scaffold promotes cellular migration, adhesion and proliferation. This results in rapid ingrowth of host tissue and assists with transition of remodelled tissue into mature tendon in the bioactive chamber created by the membrane-tendon interface. Scaffolds are not intended to replace normal body structure or provide full mechanical support for tendon repair.

Commercially available scaffolds for tendon repair are manufactured from animal or human connective tissues such as dermis, small intestine mucosa and pericardium. The tissues are processed to extract lipids, DNA and other non-collagen components, and may be cross-linked to increase mechanical strength before sterilisation. Removal of non-collagenous components is critical to avoid foreign-body reaction or rejection by the host. The final product is a membrane composed predominantly of type I and III collagen fibres. CelGro(tm) is an acellular type I/III collagen membrane of porcine origin manufactured in Australia by Orthocell Ltd and is intended for use as a resorbable bioscaffold in surgical applications. It is a Class III Medical Device. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin.

CelGro(tm) presents as a white to off-white sheet of collagen fibres with both a smooth and slightly rougher surface. Due to the natural origin of this product, small variations in thickness and surface texture may be noted. The CelGro(tm) bilayer structure has a rough, porous side that allows for the ingrowth of cells and a smooth side which prevents invasion of connective tissue. The rough side has a random and loose distribution of collagen bundles of varying size and length. The smooth side is composed of parallel arrangements of densely packed collagen bundles with abundant knitted collagen holes which enable cells and fluids to pass through to the rough side.

CelGro(tm) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type.

This trial is a pilot study to explore the use of CelGro(tm) collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60506 0
Prof Allan Wang
Address 60506 0
c/o St John of God Hosptial Medical Clinic
25 McCourt Street
Subiaco WA 6008
Country 60506 0
Australia
Phone 60506 0
+ 61 8 9366 1577
Fax 60506 0
+61 8 9311 4105
Email 60506 0
[email protected]
Contact person for public queries
Name 60507 0
Prof Allan Wang
Address 60507 0
c/o St John of God Hosptial Medical Clinic
25 McCourt Street
Subiaco WA 6008
Country 60507 0
Australia
Phone 60507 0
+61 8 9366 1577
Fax 60507 0
+61 8 9311 4105
Email 60507 0
[email protected]
Contact person for scientific queries
Name 60508 0
Dr Clair Lee
Address 60508 0
Clinical Research Manager
Orthocell Ltd
Building 191 Murdoch University
South Street
Murdoch WA 6150
Country 60508 0
Australia
Phone 60508 0
+61 8 9360 2888
Fax 60508 0
+ 61 8 9360 2899
Email 60508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified line listings - efficacy and safety data.
When will data be available (start and end dates)?
After final publication, no end date.
Available to whom?
Researchers who provide a scientifically and methodologically sound proposal which has been approved by a Human Research Ethics Committee, assessed on a case-by-case basis.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Subject to approval by the PI and Sponsor.

Email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Peilin Chen, Allan Wang, William Haynes, Euphemie ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA bio-inductive collagen scaffold that supports human primary tendon-derived cell growth for rotator cuff repair.2021https://dx.doi.org/10.1016/j.jot.2021.10.006
N.B. These documents automatically identified may not have been verified by the study sponsor.