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. (DBM)
The skull is made of multiple bones that are separated from each other at the time of birth through sutures (joints). These sutures (open spaces) allow for growth of the brain resulting in growth of the skull bones. These sutures close at different stages of life, the metopic suture is the earliest one to close at 2 years old and the latest at 26 years old. If these sutures (open spaces) close prematurely the patient develops craniosynostosis. This will result in lack of growth of the skull perpendicular to the suture line and increased growth parallel to the suture. There are different degrees of craniosynostosis that will result in anything from a slight ridge along the suture line to abnormal head shape causing constriction of the brain, developmental delays, and elevated intracranial pressure. Patients with significant abnormal head shape or patients showing any developmental delay will undergo surgical intervention. The surgery is called Cranial Vault Remodeling and it consists of opening the scalp to access the skull bones involved, then removing the bones from the underlying brain, reshaping and expanding the bone, and placing them back to protect the brain. The skull bones are held together with absorbable plates. Because the skull bones are expanded to allow for adequate brain growth there are gaps that are left without any bone. Some of these gaps are filled in with the left over small bony pieces. Other gaps are filled in with even smaller pieces of left over bone that is placed in a saw mill to form bone dust. Often, the amount of bone dust and bone pieces is not enough to fill in all the gaps. When the gaps are left unfilled it usually takes longer for these areas to be filled by the patient's own bone. This means that the brain underneath these gaps is left unprotected until they are covered with bone. At times, primarily in children 18 months or older, we find that these gaps are never fully filled requiring the child to undergo a second surgery in which bone is taken either from the ribs or the skull to fill in these gaps.
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, with bone dust , the patient's own bone pieces, in filling in these gaps versus bone dust alone. 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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.|
- Percentage of ossification [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Bone substitute
This group will receive allogenix plus demineralized bone matrix to fill in calvarial gaps after cranial vault remodelling 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. Following the conversion the material is no longer coral but a composite of highly resorbable calcium carbonate with a slower resorbing outer layer of calcium phosphate. The material retains the porous, interconnected architecture of coral which gives it a similar structure to cancellous bone, which provides a pathway for bony ingrowth.
Other Name: Allogenix Plus
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