NCT04855175

Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

Terminated NA Last updated 22 January 2025

What this trial tests

NA trial testing Synthetic Bone Allograft (ClearFit) in Surgical Procedure, Unspecified in 1 participant. Terminated before completion.

Timeline

10 February 2021

Primary endpoint
14 February 2022

14 February 2022

Quick facts

Lead sponsor	LifeBridge Health
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	10 February 2021
Primary completion	14 February 2022
Estimated completion	14 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Synthetic Bone Allograft (ClearFit)
• Autograft

Conditions studied

• Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →

Sponsor

LifeBridge Health — full company profile →

Who can join

Adults 18 to 99, any sex, with Surgical Procedure, Unspecified. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.