Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001092684
Ethics application status
Approved
Date submitted
13/09/2023
Date registered
18/10/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
18/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction. A Pilot Trial
Scientific title
Safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction. A Pilot Trial
Secondary ID [1] 310593 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Jaw reconstruction 331469 0
Facial asymmetry 331470 0
Head and neck cancer 331568 0
Condition category
Condition code
Surgery 328198 328198 0 0
Surgical techniques
Cancer 328397 328397 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of Poly Aryl Ether Ketone (PAEK) contouring implant will be offered to participants who are undergoing fibula free flap reconstruction of the mandible where there is a > 10 mm deficit in the mandible contour that would normally (without the PAEK implant) result in asymmetry.

PAEK contouring implant will be manufactured to match participant’s jaw contour using computer aided design and computer aided manufacturing.

Participants will be asked to participate in the following interventions:

Intervention
• Appointment 1 (4 - 8 weeks prior to Baseline visit and Approximately 1 hour duration):
- Informed consent
- Medical History and Clinical History
- Administration of quality of life questionnaire (Face Q)
- 3D optical facial scan
- CT scans of facial bones and fibula and intraoral scan of dentition as per standard of care.

• Appointment 2 (Baseline 8-10 hours and Approximately additional 30-45 minutes duration during the standard fibula free flap reconstruction of the mandible):
- Permanent implantation of PAEK contouring implant during fibula free flap reconstruction of the mandible
- Participants will have PAEK contouring implant permanently
- The surgical procedures will be exactly the same as a standard fibula flap reconstruction with only addition of fixation of the PAEK implant with titanium screws to the residual mandible and fibula flap.

Follow up
• Daily post operatively during participant's hospital admission (Approximately 15 minutes duration):
- Assessment of treatment related adverse event

• Day 14 post operation (Approximately 15 minutes duration):
- Assessment of treatment related adverse event

• Day 28 post operation (Approximately 15 minutes duration):
- Assessment of treatment related adverse event

• 3 months (Approximately 30 minutes duration):
- Assessment of treatment related adverse event
- Administration of quality of life questionnaire (Face Q)
- 3D optical facial scan
- CT scans of facial bones (standard of care)

• 6 months (Approximately 30 minutes duration):
- Assessment of treatment related adverse event
- Administration of quality of life questionnaire (Face Q)
- 3D optical facial scan
- CT scans of facial bones (Standard of care)

• At 12 months and then 12 monthly for 5 years (Approximately 30 minutes duration):
- Assessment of treatment related adverse event
- Administration of quality of life questionnaire (Face Q)
- 3D optical facial scan
- CT scans of facial bones (Standard of care)

Intervention will be delivered face to face in the hospital clinic/operative theatre by a qualified reconstructive surgeon.

There is no requirement for assessment of adherence. The design of PAEK contouring implant will conducted under a specific protocol to maintain the fidelity of intervention.
Intervention code [1] 327002 0
Treatment: Devices
Comparator / control treatment
Historical control group (Source: Medical Record from Chris O'Brien Lifehouse Hospital, Time Period: 5 years from September 2018 to September 2023)
Control group
Historical

Outcomes
Primary outcome [1] 336073 0
To assess the rate of adverse event and complication compared to historical controls by clinical examination by reconstructive surgeon.
Timepoint [1] 336073 0
At baseline, daily during the hospital admission after the surgery, Day 14, Day 28, 3 months, 6 months, 12 months and yearly for 5 years.
Primary outcome [2] 336074 0
To assess radiological osseointegration of PAEK contouring implant compared to historical controls by clinical examination by reconstructive surgeon.
Timepoint [2] 336074 0
3 months, 6 months, 12 months and yearly for 5 years follow up.
Secondary outcome [1] 426763 0
Change in patient quality of life measure by Face Q questionnaire.
Timepoint [1] 426763 0
Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.
Secondary outcome [2] 426764 0
Change in volumetric assessment by optical facial scan
Timepoint [2] 426764 0
Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.
Secondary outcome [3] 427457 0
Change in volumetric assessment by CT scans of facial bones
Timepoint [3] 427457 0
Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.

Eligibility
Key inclusion criteria
• 18 years and older
• Head and neck cancer
• Undergoing fibula free flap reconstruction of the mandible where there is a > 10 mm deficit in the mandible contour that would normally (without the PAEK implant) result in asymmetry
• Willingness to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active soft tissue infection or osteomyelitis
• Less than 18 years of age
• Previously undergone renal or any other allogeneic transplantation and on high dose immunosuppressive therapy
• Unable to give informed medical consent due to cognitive impairment of psychiatric illness
• Current or recent drug and/or alcohol abusers
• On high dose immunosuppressive therapy including high dose steroids and methotrexate
• A history of an endocrine, connective tissue, or metabolic disorder known to severely affect osteogenesis (e.g., Paget’s Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta)
• On other clinical trials who have received treatment with an investigational therapy within 28 days prior to reconstructive surgery or where treatment is planned during or after the follow up period

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
Other
Other design features
The use of a historical group consisting of patients treated at Chris O'Brien Lifehouse Hospital, between September 2018 to September 2023
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
The primary outcome of the study is to assess the safety and complication of PAEK Contouring Implant. The sample size of 12 has been chosen as a pilot study.

The sample size is small (12), the descriptive statistical analysis for the primary objective measure of the safety (adverse event and complication) of PAEK Contouring Implant with comparator historical control will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/07/2030
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25524 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 41345 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314803 0
Hospital
Name [1] 314803 0
Chris O'Brien Lifehouse
Country [1] 314803 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119 - 143 Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316792 0
None
Name [1] 316792 0
Address [1] 316792 0
Country [1] 316792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313814 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313814 0
Ethics committee country [1] 313814 0
Australia
Date submitted for ethics approval [1] 313814 0
15/12/2023
Approval date [1] 313814 0
31/01/2024
Ethics approval number [1] 313814 0
2023_ETH02721

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

Contacts
Principal investigator
Name 129426 0
Prof Jonathan Clark
Address 129426 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 129426 0
Australia
Phone 129426 0
+61 02 8514 0268
Fax 129426 0
Email 129426 0
[email protected]
Contact person for public queries
Name 129427 0
Masako Dunn
Address 129427 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 129427 0
Australia
Phone 129427 0
+61 02 8514 0411
Fax 129427 0
Email 129427 0
[email protected]
Contact person for scientific queries
Name 129428 0
Jonathan Clark
Address 129428 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 129428 0
Australia
Phone 129428 0
+61 02 8514 0268
Fax 129428 0
Email 129428 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?

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.