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NCT04855175 · ClinicalTrials.gov registry record · NA
Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft
A NA study, sponsored by LifeBridge Health.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT04855175: Clinical Trial NA study, sponsored by LifeBridge Health.
NCT04855175 is a NA study that was terminated before completion, run by LifeBridge Health. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04855175, a NA study, was terminated before completion, sponsored by LifeBridge Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure
Interventions
- OTHER Autograft
- DEVICE Synthetic Bone Allograft (ClearFit)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2022-02-14 |
| Phase | NA |
Why NCT04855175 stopped before completion
NCT04855175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Autograft is the first listed.
NCT04855175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04855175 about?
NCT04855175 is a clinical study titled "Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft". 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) ...
What is the current status of trial NCT04855175?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2021-02-10. Estimated completion is 2022-02-14.
What interventions are being tested in trial NCT04855175?
The interventions under investigation include: Autograft (OTHER), Synthetic Bone Allograft (ClearFit) (DEVICE).
Who is sponsoring clinical trial NCT04855175?
This trial is sponsored by LifeBridge Health, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04855175's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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