ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001157460

Ethics application status

Approved

Date submitted

22/08/2016

Date registered

25/08/2016

Date last updated

7/11/2022

Date data sharing statement initially provided

7/11/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold.

Scientific title

Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark"Collagen Scaffold.

Secondary ID [1]

CG-006

Universal Trial Number (UTN)

U1111-1186-7168

Trial acronym

Linked study record

Health condition

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

Peripheral nerve injury

Condition category

Condition code

Surgery

Surgical techniques

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold:
CelGro "Registered Trademark is a next-generation porcine collagen membrane manufactured in Australia from locally-produced source material. It is classified as a Class III Medical Device and is intended for use in surgical applications such as tendon and soft tissue repair and guided tissue regeneration.
This is an open label pilot study where adult patients who have a traumatic injury to one or more of the peripheral nerves of the upper limb or hand that requires surgical repair will receive a single surgical implantation of CelGro "Registered Trademark at the site of the nerve end repair to be used as a conduit for nerve repair. The implantation will be performed by an Orthopaedic surgeon. The length of surgery time and recovery will depend on the number of nerves damaged and the size of the nerve gap.

Haemostasis of the nerve ends will be achieved prior to placement of CelGro"Registered Trademark". Tensionless repair will be achieved using atraumatic sutures to secure the CelGro"Registered Trademark" scaffold to the epineurium of each nerve end, resulting in a tube of CelGro"Registered Trademark" connecting and encasing the nerve ends. The site of CelGro"Registered Trademark" attachment to each nerve end will be a distance approximately greater than or equal to the nerve diameter. Fibrin glue may be used to assist with adhesion. The size of the CelGro"Registered Trademark" scaffold used will depend on the size of the nerve gap.
CelGro"Registered Trademark" is a classified as a medical device and is delivered in a sterile sealed pouch and presents as a white to off white sheet with a smooth and a slightly rough side and is intended for single use only.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Adverse events related to study treatment or procedures.

Adverse events will be assessed by clinical examination and participant interview at each study visit. Intensity will be graded as either: mild. moderate, severe, or extreme.

Adverse events related to study treatment may include infection at the surgical site and allergic reaction to the investigational device. Adverse events related to surgery may include discomfort and swelling, and other standard risks associated with anaesthesia and surgery of this kind.

Timepoint [1]

Assessments will occur at 1, 6, 12 and 24 months post-treatment.

Primary outcome [2]

Additional surgical or significant medical intervention required as a result of treatment failure (assessed at each study visit by the treating investigator).

Timepoint [2]

Up to 24 months post-treatment.

Primary outcome [3]

Motor function assessment (MRC criteria).

Timepoint [3]

1, 6, 12, and 24 months post treatment

Secondary outcome [1]

Sensory assessment (static and moving two-point discrimination)

Timepoint [1]

1, 6, 12, and 24 months post treatment.

Secondary outcome [2]

Upper limb function as assessed by the QuickDASH score.

Timepoint [2]

6, 12, and 24 months post treatment.

Secondary outcome [3]

Visual analogue scale (VAS) pain score

Timepoint [3]

7-14 days, and months 1, 6, 12, and 24 post treatment.

Secondary outcome [4]

Quality of life as assessed by the AQoL-6D score.

Timepoint [4]

6, 12, and 24 months post treatment.

Secondary outcome [5]

Nerve damage as assessed by Tinel’s sign.

Timepoint [5]

7-14 days, and months 1, 6, 12, and 24 post treatment.

Eligibility

Key inclusion criteria

Male or female aged 18-50 years.
Traumatic injury to one or more peripheral nerves of the upper limb or hand requiring surgical repair.
Nerve gap <20mm.
Able to require to the requirements of the protocol.
Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP.

Minimum age

18 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Nerve gap >20mm
Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders.
Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy.
Female participant who is pregnant or lactating.
Known substance abuse.
Participation in another study with an investigational product within the last 3 months of study treatment date.
Concurrent medical condition which precludes the administration of the 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

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Demographic data will be displayed and summary statistics used to describe the study population

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2016

Actual

20/12/2016

Date of last participant enrolment

Anticipated

1/07/2018

Actual

23/04/2020

Date of last data collection

Anticipated

1/07/2020

Actual

18/03/2022

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]

St John of God Hospital, Murdoch - Murdoch

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6150 - Murdoch

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]

05/09/2016

Approval date [1]

12/10/2016

Ethics approval number [1]

SJOG HREC 1036

Summary

Brief summary

CelGro "Registered Trademark is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens.
Treatment of injuries to peripheral nerves is a challenging surgical issue.  The primary aim of surgical repair is to guide regenerating axons correctly into place in the distal nerve, with minimal loss of nerve fibres at the site of repair.  This results in reinnervation of distal tissues, and restores autonomic, sensory and motor function.  
Direct, tensionless, end-to-end repair using epineural microsutures (neurorhaphy) provides the most favourable outcomes.  Tensionless repair is acknowledged as a major factor in successful recovery of sensorimotor function.  However, if a tensionless repair cannot be achieved, autologous nerve grafting is the gold standard treatment for surgical treatment of nerve gaps.  However, autologous nerve grafting results in significant donor-site morbidity; is more technically difficult to perform; requires more operative time; and elevates treatment costs.
The search for alternatives to nerve grafting has resulted in the development of nerve conduits, which are tubes fashioned of biocompatible materials.  The proximal and distal ends of the severed nerve are inserted into the tube and sutured in place.  The conduit provides gross alignment for the regenerating nerve, and retains fluids leaking from the nerve ends, enriching the microenvironment with neurotrophic growth factors.  Conduits manufactured from bioabsorbable materials are preferred as non-degradable materials such as silicone require additional surgery for removal, and may have detrimental effects on nerve regeneration.
Collagen is one of the most commonly used biomaterials for construction of nerve conduits.  Key advantages of collagen are that it is biocompatible and has a natural structure that has been shown to support and guide tissue regeneration in vivo.  Clinical studies have shown that digital nerve gaps of up to 40mm can be bridged with collagen conduits, resulting in good to excellent sensory outcomes in up to 75% of patients. 

CelGro"registered trademark" is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro"registeris mechanically stronger and more elastic than other collagen membrane products of this type.
The main complication related to conduit implantation is protrusion or extrusion of the conduit.  This is most common when the repair occurs across a joint or where the quality of covering soft tissue is reduced.  However, in a systematic review of digital nerve repair using resorbable FDA- and CE-approved nerve conduits, protrusion or extrusion of collagen conduits was not observed

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alex O'Beirne

Address

Western Orthopaedic Clinic
Suite 213
25 McCourt Street
Subiaco
WA 6009

Country

Australia

Phone

+618 9489 8799

Fax

elise@wocwa.com

Contact person for public queries

Name

Alex O'Bierne

Address

Western Orthopaedic Clinic
Suite 213
25 McCourt Street
Subiaco
WA 6009

Country

Australia

Phone

+618 9489 8799

Fax

elise@wocwa.com

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 6360 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 efficacy/safety line listings.

When will data be available (start and end dates)?

After publication, no end date.

Available to whom?

Researchers who provide a methodologically and scientifically sound research proposal that has received Human Research Ethics Committee approval, as 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 from the Principal Investigator 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

No additional documents have been identified.

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