Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-29

Study Completion Date

2026-08-29

Brief Summary

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This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.

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Detailed Description

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The study aims to:

1. Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
2. Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).

Conditions

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Traumatic Brain Injury Acquired Brain Injury Brain Tumor Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Version 1 Head protection Device 2021

Version 2 Head protection device 2025

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Unilateral decompressive craniectomy (DC)
* Acute Stroke or traumatic brain injury
* \>30 days post DC
* Healed surgical wounds, non-bulging flaps
* Presence of caregiver supervision

Exclusion Criteria

* Vegetative or minimally responsive state
* Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
* Life expectancy \< 6 months
* Unhealed or infected post-DC neurosurgical wounds
* Known allergy to investigational products

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No