None listed
Conditions
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.
Interventions
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 subsequ
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
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed