Comparison of a Bone Product to Bone Dust in Ossification of Small Calvarial Defects.
Public ClinicalTrials.gov record NCT01006148. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of Allogenix Plus Demineralized Bone Matrix and Autogenous Bone Dust Versus Autogenous Bone Dust Alone in Ossification of Small Calvarial Defects, a Pilot Study.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this study we want to compare the effectiveness of a bone substitute (Allogenix Plus, a product derived from a dead human being that has chosen to donate it prior to dying) and bone dust from the patient's own bone pieces, versus bone dust alone in filling in the gaps that sometimes occur after surgery for craniosynostosis . We will compare the percent of defect filled at 1 year in 5 patients 18 months or older with metopic craniosynostosis that received the bone substitute plus their bone dust with 5 previously operated patients with similar characteristics that received bone dust alone to fill in the gaps. The bone substitute that we are using will be provided at no cost by the company Biomet Microfixation. The bone substitute Allogenix Plus undergoes extensive screening for infectious diseases as well as processing to prevent a rejection. The product will be applied during standard surgery to 5 patients with metopic craniosynostosis of 18 months or older with skull defects no larger than 25 cm2, so it does not require any additional surgeries. Aside from the placement of this bone substitute the patient will proceed to receive the standard of care which includes a pre-operative CT scan, immediate post-operative CT scan, and 1 year post-operative CT scan of the Head. We will review these scans and look at percent of bony growth in the bone substitute plus bone dust group . We will also see the patients in clinic, during standard of care follow-up visits at 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months, and 1 year post-operatively. During clinic visits we will monitor the patient closely for any potential side effects of the bone substitute as well as complications of the surgery. We will then review the charts of 5 patients 18 months or older that have undergone surgery for metopic craniosynostosis until 5 patients with similar characteristics and defect size have been obtained. We will compare their post-operative CT scans and pictures and we will look at bone growth, bone resorption, bone gaps present, and need for secondary surgeries.
Study identification
- NCT ID
- NCT01006148
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Months to 36 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2009
- Primary completion
- Jul 31, 2010
- Completion
- Jul 31, 2010
- Last update posted
- Sep 29, 2016
2009 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Missouri Hospital and Clinics | Columbia | Missouri | 65202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01006148, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2016 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01006148 live on ClinicalTrials.gov.