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Comparison of a Bone Product to Bone Dust in Ossification of Small Calvarial Defects. (DBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006148
Recruitment Status : Withdrawn (problems obtaining the investigational agent, Allogenix(TM) Plus)
First Posted : November 1, 2009
Last Update Posted : September 30, 2016
Zimmer Biomet
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metopic Craniosynostosis Biological: Allogenix Plus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Bone substitute
Enrollees will receive Allogenix Plus(TM), a demineralized bone matrix, to fill in calvarial gaps after cranial vault remodeling and fronto-orbital advancement.
Biological: Allogenix Plus
It is a demineralized bone matrix obtained using cortical or cancellous allograft bone that is treated to remove surface lipids and then dehydrated with ethanol and ethyl esther. It is further processed leaving behind proteins, bone growth factors, and collagen. It is combined with lecithin a which is resistant to breakdown by body fluids. It contains Pro Osteon Implant 500R a naturally derived material made from a non-decorative form of coral, which is subject to a patented thermal process, which converts the coral to hydroxyapatite.

Primary Outcome Measures :
  1. Percentage of ossification [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children between the ages of 18 months and 36 months with metopic craniosynostosis undergoing cranial vault remodeling with defects 25 cm squared or less

Exclusion Criteria:

  • Allergic reaction to any of the components of the bone substitute Allogenic Plus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006148

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United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65202
Sponsors and Collaborators
University of Missouri-Columbia
Zimmer Biomet
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Principal Investigator: Arshad Muzaffar, MD University of Missouri-Columbia

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Responsible Party: University of Missouri-Columbia Identifier: NCT01006148    
Other Study ID Numbers: IRB 1146218
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Missouri-Columbia:
Metopic Craniosynostosis
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities