Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001213538
Ethics application status
Approved
Date submitted
18/09/2024
Date registered
3/10/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
3/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of Remplir™ Collagen Membrane in Peripheral Nerve Surgery
Scientific title
A retrospective and prospective observational study on the safety and performance of Remplir™ collagen membrane used in patients who underwent peripheral nerve surgery
Secondary ID [1] 311081 0
REM-AOB-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral nerve injury 332726 0
Condition category
Condition code
Surgery 329443 329443 0 0
Other surgery
Neurological 331836 331836 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure being observed is the use of Remplir collagen membrane in peripheral nerve surgery.

The observation period will be dependent on the specific indication/intention of the surgical procedure and associated length of time required to assess the success of the procedure:
- Peripheral nerve protection (e.g. during treatment of compression syndromes/peripheral nerve tumour excision, or prophylactic use during other surgical procedures) - 6 months
- Neuroma management (treatment or prevention) - 12 months
- Reconstruction of peripheral nerve (including nerve transfer/free-functioning muscle transfer) - up to 24 months

Participants still in normal clinical follow-up will be asked to provide consent for data collection, and to complete a global rating of change questionnaire.

All patients who underwent (or undergo) a peripheral nerve procedure using Remplir with the site investigator(s) from the 1st January 2019 until closure of prospective recruitment will be screened for eligibility.
Intervention code [1] 327880 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337261 0
Safety of Remplir used in peripheral nerve surgery.
Timepoint [1] 337261 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Primary outcome [2] 338215 0
Treatment success according to the underlying condition and type and intent of the procedure in which Remplir™ was used.

Reconstruction of peripheral nerve (including nerve transfer and free functioning muscle transfer):
- Sensory target: functional sensory recovery
- Motor target: functional motor recovery
Timepoint [2] 338215 0
Within 24 months post-treatment, assessed at 1-3, 6, 12, and 24 months or according to standard of care clinical follow-up.
Primary outcome [3] 339463 0
Treatment success according to the underlying condition and type and intent of the procedure in which Remplir™ was used.

Neuroma management:
- Treatment of pre-existing neuroma: pre-operative symptoms improved or completely relieved (peripheral nerve symptoms assessment), and no recurrence of symptomatic neuroma (composite endpoint)
- Neuroma prophylaxis: no symptomatic neuroma formation at treatment site
Timepoint [3] 339463 0
Assessed at 1-3, 6, and 12 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [1] 431257 0
Primary outcome #4
Treatment success according to the underlying condition and type and intent of the procedure in which Remplir™ was used.

Peripheral nerve protection (without nerve reconstruction):
Pre-operative symptoms improved or completely relieved (for symptomatic conditions)/No new onset nerve injury symptoms (for prophylactic treatment).
Timepoint [1] 431257 0
Assessed at 1-3, 6, and 12 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [2] 435006 0
Manual muscle test (MRC)
Timepoint [2] 435006 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [3] 435008 0
Static two-point discrimination (S2PD)
Timepoint [3] 435008 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [4] 435009 0
Semmes-Weinstein Monofilament Test (SWMT)
Timepoint [4] 435009 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [5] 435010 0
NRS/VAS pain score
Timepoint [5] 435010 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [6] 440071 0
Peripheral nerve symptoms assessment
Timepoint [6] 440071 0
Assessed at 1-3, 6, and 12 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [7] 440078 0
Muscle strength (dynamometry)
Timepoint [7] 440078 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [8] 440079 0
Symptomatic neuroma formation
Timepoint [8] 440079 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [9] 440080 0
Post-treatment use of medication for neuropathic pain.
Timepoint [9] 440080 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [10] 440081 0
Additional surgical procedures involving the same peripheral nerve(s) or muscle/sensory target(s)
Timepoint [10] 440081 0
Assessed at 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [11] 440082 0
Description of peripheral nerve procedure involving Remplir.
Timepoint [11] 440082 0
Baseline (time of treatment with Remplir)
Secondary outcome [12] 440083 0
Device deficiencies
Timepoint [12] 440083 0
Assessed at baseline (time of treatment with Remplir), 1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.
Secondary outcome [13] 440084 0
Global Rating of Change (GROC)
Timepoint [13] 440084 0
1-3, 6, 12, and 24 months post-treatment, or until participant discharge from standard of care clinical follow-up.

Eligibility
Key inclusion criteria
Retrospective cohort:
1. Underwent a peripheral nerve procedure using Remplir™.
2. No longer in clinical follow-up at the time of study enrolment.
3. Completed at least one outpatient follow-up visit post peripheral nerve procedure using Remplir™.

Prospective cohort:
1. Underwent a peripheral nerve procedure using Remplir™.
2. Able to give informed consent in accordance with ICH GCP.
3. If <18 years of age at the time of study enrolment, able to give assent, and parent or legal guardian able to give informed consent in accordance with ICH GCP.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participated in the CG-006 clinical trial.
2. Specifically requested that their data was not to be used for research purposes (retrospective cohort only).

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315338 0
Commercial sector/Industry
Name [1] 315338 0
Orthocell Ltd.
Country [1] 315338 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd.
Address
Building 191, Murdoch University Murdoch WA 6150 Australia
Country
Australia
Secondary sponsor category [1] 319071 0
None
Name [1] 319071 0
Address [1] 319071 0
Country [1] 319071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314261 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 314261 0
Ethics committee country [1] 314261 0
Australia
Date submitted for ethics approval [1] 314261 0
27/09/2024
Approval date [1] 314261 0
17/10/2024
Ethics approval number [1] 314261 0

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

Contacts
Principal investigator
Name 130970 0
Dr Alex O'Beirne
Address 130970 0
Wexford Medical Centre Suite 13, 3 Barry Marshall Pde, Murdoch, WA 6150
Country 130970 0
Australia
Phone 130970 0
+610861663778
Fax 130970 0
Email 130970 0
[email protected]
Contact person for public queries
Name 130971 0
Luke Hanrahan
Address 130971 0
Building 191, Murdoch University Murdoch WA 6150 Australia
Country 130971 0
Australia
Phone 130971 0
+610893602888
Fax 130971 0
Email 130971 0
[email protected]
Contact person for scientific queries
Name 130972 0
Clair Lee
Address 130972 0
Building 191, Murdoch University Murdoch WA 6150 Australia
Country 130972 0
Australia
Phone 130972 0
+61893602888
Fax 130972 0
Email 130972 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21104Ethical approval  [email protected]



Results publications and other study-related documents

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