Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000581460
Ethics application status
Approved
Date submitted
13/04/2025
Date registered
4/06/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Jaw reconstruction in adults using a bioresorbable scaffold system: a safety and feasibility study
Scientific title
Safety and Tolerability of a Medical-Grade Polycaprolactone and Tricalcium Phosphate Scaffold System with Corticoperiosteal Tissue Transfer for the Reconstruction of Maxillary and Mandibular Defects in Adults
Secondary ID [1] 314015 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired defects in the mandible 336756 0
Acquired defects in the maxilla 337571 0
Condition category
Condition code
Surgery 333245 333245 0 0
Surgical techniques
Oral and Gastrointestinal 334004 334004 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single arm feasibility trial. The intervention will involve the reconstruction of maxillary or mandibular defects with the surgical placement of a custom implant made of medical grade polycaprolactone and tricalcium phosphate,(mPCL-TCP) in combination with a corticoperiosteal free flap (CPF) that will be harvested from each participant. The mPCL-TCP implant will be designed using 3D segmentation software based on CT imaging (Materialise, Belgium). The mPCL-TCP implant will be manufactured, sterilised and shipped by the medical device company, Osteopore. A reconstructive surgeon will be administering the surgical intervention, with an estimated surgical duration of three hours. A CPF is a unit of tissue including cortical bone and periosteum that is harvested with its blood supply. Common sites of CPF harvest include the medial femoral condyle and the fibula. Following the surgical placement of the scaffold system, participants will attend regular followup appointment to assess for primary and secondary outcomes.
Intervention code [1] 330596 0
Treatment: Devices
Intervention code [2] 330597 0
Treatment: Surgery
Comparator / control treatment
As this is a newer technique for jaw reconstruction that has not been tested in a clinical trial, it is appropriate to conduct a single arm feasibility trial without a comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340811 0
Safety and tolerability
Assessment method [1] 340811 0
Reporting will be performed according to the Guideline for Good Clinical Practice, the National Institute of Health Common Terminology for Adverse Events v5.0 (CTCAE) framework and the Australian Therapeutic Goods Administration (TGA) guidelines on Medical Device Adverse Event Reporting. Possible adverse events include but are not limited to infection, bleeding, or jaw stiffness.
Timepoint [1] 340811 0
Regular follow-up will occur to assess for primary outcomes at 2 weeks, 6 weeks, 3 months, 12 months, 18 months, 24 months, 30 months and 36 months post-operatively.
Secondary outcome [1] 445118 0
Radiological assessment of the development of regenerate bone in scaffolds.
Assessment method [1] 445118 0
Segmentation and volumetric analysis of serial CT scans using a predefined CT imaging protocol.
Timepoint [1] 445118 0
CT scans will occur at 6 weeks, 12 months, 24 months, and 36 months post-operatively.
Secondary outcome [2] 446194 0
Patient reported outcome measure
Assessment method [2] 446194 0
Validated outcome measurement tool: Speech Handicap Index (SHI)
Timepoint [2] 446194 0
Pre-operatively, 12 months, 24 months, and 36 months post-operatively.
Secondary outcome [3] 446195 0
Aesthetic result.
Assessment method [3] 446195 0
Conventional and three dimensional photographs.
Timepoint [3] 446195 0
Pre-operatively, 12 months, 24 months, and 36 months post-operatively.
Secondary outcome [4] 448255 0
Patient reported outcome measure
Assessment method [4] 448255 0
Validated outcome measurement tool: Face-Q Head and Neck Cancer Module (FQHNC)
Timepoint [4] 448255 0
Pre-operatively, 12 months, 24 months, and 36 months post-operatively.
Secondary outcome [5] 448256 0
Patient reported outcome measure
Assessment method [5] 448256 0
Validated outcome measurement tool: University of Washington Quality of Life Index (UoWQLI)
Timepoint [5] 448256 0
Pre-operatively, 12 months, 24 months, and 36 months post-operatively.

Eligibility
Key inclusion criteria
1. Acquired defect of the maxilla or mandible.
2. Bone defect size that is less than one half of the tooth-bearing part of the maxilla/mandible.
3. Patient aged 18 years and over.
4. Patient willing and able to comply with the study requirements.
5. Patient or substitute decision maker capable of providing valid informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Bone defect size that is more than one half of the tooth-bearing part of the maxilla/mandible.
2. Bone defects that include the condylar process of the mandible.
3. Patients who have undergone maxillectomy or mandibulectomy in the setting of ablative surgery for head and neck malignancy who have not had margin status confirmed.
4. Active infection of the mandible or maxilla at the time of study inclusion, demonstrated by a failed trial off antibiotics in chronic infected cases.
5. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
6. Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological illness, psychiatric disorders, or alcohol or chemical dependence, and/or possible allergies that would, in the opinion of the primary investigator, compromise their safety or compliance or interfere with interpretation of study results.
7. Women who are currently pregnant or breast feeding.
8. Women of childbearing potential without an appropriate contraceptive method.
9. Patient life expectancy < 36 months.
10. Patient unable or unwilling to provide valid informed consent or comply with the treatment protocol.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318519 0
Hospital
Name [1] 318519 0
Princess Alexandra Hospital
Country [1] 318519 0
Australia
Primary sponsor type
Government body
Name
Metro South Hospital and Health Service
Country
Australia
Secondary sponsor category [1] 321150 0
None
Name [1] 321150 0
Country [1] 321150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317125 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317125 0
Ethics committee country [1] 317125 0
Australia
Date submitted for ethics approval [1] 317125 0
14/01/2025
Approval date [1] 317125 0
17/04/2025
Ethics approval number [1] 317125 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 140078 0
Dr Michael Wagels
Address 140078 0
The Australian Centre for Complex Integrated Surgical Solutions, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140078 0
Australia
Phone 140078 0
+61 07 3176 4448
Email 140078 0
michael.wagels@health.qld.gov.au
Contact person for public queries
Name 140079 0
Lana Del Vecchio
Address 140079 0
The Australian Centre for Complex Integrated Surgical Solutions, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140079 0
Australia
Phone 140079 0
+61 07 3176 4448
Email 140079 0
lana.delvecchio@health.qld.gov.au
Contact person for scientific queries
Name 140080 0
Lana Del Vecchio
Address 140080 0
The Australian Centre for Complex Integrated Surgical Solutions, Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
Country 140080 0
Australia
Phone 140080 0
+61 07 3176 4448
Email 140080 0
lana.delvecchio@health.qld.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.