ANZCTR - Registration

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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rotator Cuff Tendinopathy

Rotator Cuff Tear

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

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]

Treatment: Other

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Measurement of tendon healing by MRI assessment.

Timepoint [1]

6 and 12 months post-treatment.

Secondary outcome [1]

Pain, assessed by VAS pain score.

Timepoint [1]

3, 6 and 12 months post-treatment.

Secondary outcome [2]

Symptoms assessed by OSS, CMS and ASES

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

St John of God Hospital, Subiaco - Subiaco

Recruitment hospital [2]

Mercy Hospital Mount Lawley - Mount Lawley

Recruitment hospital [3]

St John of God Hospital, Murdoch - Murdoch

Recruitment hospital [4]

St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6050 - Mount Lawley

Recruitment postcode(s) [3]

6150 - Murdoch

Recruitment postcode(s) [4]

3002 - East Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Orthocell Ltd

Address [1]

Building 191
Murdoch University
South Street
Murdoch WA 6150

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St John of God Health Care HREC

Ethics committee address [1]

12 Salvado Road
Subiaco WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/09/2015

Approval date [1]

09/12/2015

Ethics approval number [1]

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

Prof Allan Wang

Address

c/o St John of God Hosptial Medical Clinic
25 McCourt Street
Subiaco WA 6008

Country

Australia

Phone

+ 61 8 9366 1577

Fax

+61 8 9311 4105

AllanWang@aapt.net.au

Contact person for public queries

Name

Allan Wang

Address

c/o St John of God Hosptial Medical Clinic
25 McCourt Street
Subiaco WA 6008

Country

Australia

Phone

+61 8 9366 1577

Fax

+61 8 9311 4105

AllanWang@aapt.net.au

Contact person for scientific queries

Name

Clair Lee

Address

Clinical Research Manager
Orthocell Ltd
Building 191 Murdoch University
South Street
Murdoch WA 6150

Country

Australia

Phone

+61 8 9360 2888

Fax

+ 61 8 9360 2899

clair.lee@orthocell.com.au

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: luke.hanrahan@orthocell.com.au

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

Source	Title	Year of Publication	DOI
Embase	A bio-inductive collagen scaffold that supports human primary tendon-derived cell growth for rotator cuff repair.	2021	https://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.

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Documents added manually

Documents added automatically