Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft - Trial NCT04855175

Timeline & Enrollment

Primary Outcome

To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit),To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit),To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit),To assess change the surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)

Summary

Elevated intracranial pressure (ICP) is a common neurosurgical emergency that may arise from
 several conditions, which cause an intracranial mass effect. In the case of conservatively
 refractory ICP elevation, one viable treatment option is ICP-lowering surgery, i.e.,
 decompressive craniectomy (DC) in which a large portion of the skull bone is removed and the
 dura mater opened, creating more room for the brain tissue to expand and thus reducing the
 ICP. A successful CP will restore the contour of the cranium, protect the brain, and ensure a
 natural ICP, and some patients also show neurological improvement post-CP. Thus, CP has a
 great potential for improving the patient's quality of life.
 
 Bone flap resorption (BFR) implies weakening and loosening of the autologous bone flap after
 reimplantation and is regarded as a late CP complication involving nonunion of the bone flap
 with the surrounding bone margins and cavity formation in the flap itself, which eventually
 necessitates removal of the bone flap and a new CP using a synthetic implant. These
 additional operations increase costs and necessitate further hospital stays, while rendering
 the patient vulnerable to additional complications.
 
 Prior research performed as part of the FDA approval process has shown the ASPCI's to be a
 safe and effective means of performing cranial reconstruction, the anticipated risks do not
 differ from the risks faced by a patient undergoing either option as they are both currently
 considered standards of care.
 
 This study will evaluate the overall patient outcomes of cranial reconstruction surgery using
 native bone autograft as compared to using synthetic bone allograft.

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