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Trial registered on ANZCTR


Registration number
ACTRN12620001171909
Ethics application status
Approved
Date submitted
8/08/2020
Date registered
9/11/2020
Date last updated
31/10/2022
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-arm feasibility trial evaluating a protein-based scaffold system with tissue transfer for the reconstruction of skull fractures
Scientific title
A single-arm feasibility trial evaluating the medical grade polycaprolactone/tricalcium phosphate (PCL-TCP) scaffold system with corticoperiosteal tissue transfer for the reconstruction of acquired calvarial defects in adults
Secondary ID [1] 301987 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired defect of the calvanium - trauma, malignancy or osteomyelitis 318547 0
Salvage of failed calvarial reconstruction 318944 0
Condition category
Condition code
Surgery 316555 316555 0 0
Surgical techniques
Injuries and Accidents 316915 316915 0 0
Fractures
Injuries and Accidents 316916 316916 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional
Extended long bone reconstruction using an mPCL-TCP scaffold with recombinant human bone morphogenetic protein 7 (rhBMP-7) in conjunction with a vascularised corticoperiosteal tissue transfer.

The service will be provided by Consultant Plastic and Reconstructive Surgeons working out of Metro South/Metro North hospital system

The procedure typically takes between 8-10 hours which includes management of the calvarial defect, raising of the corticoperiosteal free flap and subsequent reconstruction of the area
The patients will all be discussed pre-operatively in multidisciplinary team (MDT) meetings for pre-operative computed tomography (CT) planning to define defect size. Scaffolds are customised via 3D (CT) imaging and produced by Osteopore International P/L

Post-operatively patients will be reviewed by neurosurgical and plastic surgery teams to assess progress. The patients intra-operative course will be reviewed in subsequent MDT meetings to ensure appropriate surgical technique and to assess progress. Surgeons will have the option of meeting with an Osteopore representative to further clarify questions around scaffold design and surgical technique
Intervention code [1] 318273 0
Treatment: Surgery
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324682 0
The feasibility of an mPCL-TCP scaffold with rhBMP-7 in conjunction with a vascularised corticoperiosteal tissue transfer for the reconstruction of calvarium defects will be assessed by comparing the volume of bone regeneration and complications (e.g. infection, bone resorption, return to theatre) compared to standard reconstruction techniques (e.g. autologous bone grafting, alloplastic reconstructive techniques). Outcomes will be determined from post-operative CT head scans to assess bone regeneration/resorption and through auditing subsequent returns to theatre and follow up notes to screen for complications.
Timepoint [1] 324682 0
Assessed at 4 weeks, 3 months, 6 months, 12 months and 24 months post-intervention. This may be extended to 36 months if clinically required.
Post-operative CT will be performed at 3, 12 and 24 months to assess time to radiological (CT) union of the defect. Clinical follow up will be carried out to assess time to clinical union of defect
Primary outcome [2] 324683 0
The functionality of an mPCL-TCP scaffold with rhBMP-7 in conjunction with a vascularised corticoperiosteal tissue transfer for the reconstruction of calvarium defects will be assessed by comparing not only pre and post-operative calvarial contouring. Outcomes will be determined by post-operative CT head scanning to quantify change
Timepoint [2] 324683 0
Assessed at 4 weeks, 3 months, 6 months, 12 months and 24 months post-intervention
Primary outcome [3] 325325 0
and also through patient satisfaction by asking them to complete the short-form health survery (SF-36)
Timepoint [3] 325325 0
Assessed at 3 months, 12 months and 24 months post-intervention
Secondary outcome [1] 385396 0
Evaluate the cost-effectiveness of this approach with a view to application in a broader range of clinical situations. This will be accomplished by calculating the difference between resource use and cost from hospital records. Further comparison will be drawn from costs of conventional procedures as evidenced throughout the literature.
Timepoint [1] 385396 0
Assessed at 3 months, 12 months and 24 months post-intervention
Secondary outcome [2] 386573 0
Functional recovery assessed using the Short Musculoskeletal Function Assessment
Timepoint [2] 386573 0
Assessed at 3 months, 12 months and 24 months post-intervention
Secondary outcome [3] 386574 0
Short form survey (SF-36) to assess physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health (Composite Secondary Outcome)
Timepoint [3] 386574 0
Assessed at 3 months, 12 months and 24 months post-intervention
Secondary outcome [4] 387509 0
Functional measures beyond the SF-36 survey will include time to return to work and other pre-operative activities (Primary Outcome)
Timepoint [4] 387509 0
Assessed at 3 months, 12 months and 24 months post-intervention

Eligibility
Key inclusion criteria
• Acquired intercalary defect of the calvarium
• Patient aged >18 and <55 years
• Patients aged over 55 may still be eligible for trial after assessment by and at the discretion of the investigators with documentation to that effect provided for the trial documents pertaining to such patients.
• Patient willing and able to comply with the study requirements.
• Patient capable of providing valid informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active infection of the calvarium at the time of study inclusion, manifest as a failed trial off antibiotics in chronic infected cases.
• Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
• Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
• Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the primary investigator, compromise their safety or compliance or interfere with interpretation of study results.
• Patient life expectancy < 36 months.
• Patient unable or unwilling to 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
25/08/2021
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
10
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306408 0
Commercial sector/Industry
Name [1] 306408 0
Osteopore International Pty
Country [1] 306408 0
Singapore
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, QLD
4102
Country
Australia
Secondary sponsor category [1] 306916 0
Commercial sector/Industry
Name [1] 306916 0
Osteopore International
Address [1] 306916 0
2 Tukang Innovation Grove, #09-06 MedTech Hub, Singapore 618305
Country [1] 306916 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306606 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 306606 0
199 Ipswich Road
Woolloongabba
QLD 4102
Ethics committee country [1] 306606 0
Australia
Date submitted for ethics approval [1] 306606 0
18/06/2020
Approval date [1] 306606 0
15/07/2020
Ethics approval number [1] 306606 0
HREC/2020/QMS/66054

Summary
Brief summary
This study is an open label single arm trial coordinated by the Investigators at the Princess Alexandra Hospital (PAH) in Woolloongabba (Queensland, Australia), the Australian Centre for Complex Integrated Surgical Solutions at the Translational Research Institute (Queensland, Australia) and the Centre for Regenerative Medicine at the Institute of Health and Biomedical Innovation in Kelvin Grove (Queensland, Australia). The primary purpose of this study is to assess the feasibility of surgical placement of a new protein scaffold in conjunction with free tissue transfer for bone reconstruction in patients who have an acquired skull defect secondary to trauma, malignancy or infection. Experimental data suggests augmented bone regeneration of this new protein scaffold when combined with autologous vascularised free tissue from the subject. It is hypothesised that this method of reconstruction will result in superior regeneration of skull bone with improved cosmesis at a reduced cost to hospital and patient. This will be assessed through pre-and post-operative CT imaging to quantify bone regeneration. This will be compared to previous types of skull reconstruction in terms of functionality (i.e. cosmesis and patient satisfaction) and financial implications (i.e. costs associated with operation(s) and complications). Patients will be followed up at 4weeks, 3, 6, 12 and 24 months to assess to adequate bony union (through CT and clinical exam) as well as completed surveys of their experience and physical, mental, emotional and social outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104442 0
Dr Michael Wagels
Address 104442 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 104442 0
Australia
Phone 104442 0
+61 406183619
Fax 104442 0
Email 104442 0
[email protected]
Contact person for public queries
Name 104443 0
Michael Wagels
Address 104443 0
Princes Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 104443 0
Australia
Phone 104443 0
+61 406183619
Fax 104443 0
Email 104443 0
[email protected]
Contact person for scientific queries
Name 104444 0
Michael Wagels
Address 104444 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 104444 0
Australia
Phone 104444 0
+61 406183619
Fax 104444 0
Email 104444 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.