Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 14, 2022
Date Accepted: Jun 20, 2022
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
ABSTRACT
Background:
Large skull defects present a reconstructive challenge. Conventional cranioplasty options include autologous bone grafts, vascularised bone, metals, synthetic ceramics and polymers. Autologous options are affected by resorption and residual contour deformity. Synthetic materials may be customised with digital planning and 3D printing but all carry a risk of implant exposure, failure and infection, which are increased when the defect is large. These complications can be a threat to life. Without a reconstruction, patients with cranial defects may suffer headaches and stigmatisation. Protection of the brain necessitates lifelong helmet use, which is also stigmatising.
Objective:
A hybridised technique that draws on the benefits of autologous and synthetic materials has been developed by the research team. This involves wrapping a biodegradable ultra-structured 3D printed scaffold made from medical-grade polycaprolactone and tricalcium phosphate (mPCL-TCP) in vascularised autotransplanted periosteum. In vitro, the scaffold system supports cell attachment, migration and proliferation with slow but sustained degradation to permit host tissue regeneration and replacement of the scaffold. In vivo compatibility of this scaffold system is robust - the base material has been used clinically as resorbable suture material for decades. The importance of scaffold vascularisation, which is inextricably linked to bone regeneration, is underappreciated. A variety of methods have been described to address this including scaffold pre-lamination, axial vascularisation with arteriovenous loops and autotransplanted flaps. None of these directly promote bone regeneration.
Methods:
The mPCL-TCP scaffold is wrapped in autotransplanted vascularised corticoperiosteal tissue to exploit the capacity of vascularised periosteum to regenerate bone.
Results:
We expect to have results before the end of 2023.
Conclusions:
This clinical trial will formally study the technique's capacity to reconstruct large calvarial defects. Clinical Trial: ANZ Clinical Trial Registry/ACTRN12620001171909
Citation
Per the author's request the PDF is not available.
Copyright
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