Osteogenic Profiling of Tissue From Children With Craniosynostosis
Condition: Craniosynostosis
MeSH terms: Craniosynostoses
Study type: Interventional

Summary: 
      The primary objectives of this study are

        -  to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples
           from children with craniosynostosis,

        -  to grow cells from these tissues in vitro,

        -  to evaluate the osteogenic potentials of these cell types.
    

Detailed description: 
      The screening procedures include review and collection of information from the patient's
      medical record, Name, Date of Birth, Medical record number, clinical diagnosis of
      classification of craniosynostosis, genetic screen for syndromic synostosis (FGFR, TWIST,
      MSX2 mutation screen), and a clinical examination at the Cleft -Craniofacial Center. During
      the clinical examination, the plastic surgeon will determine the presence of a
      craniosynostosis and the need for surgical intervention. The evaluation and surgical repair
      of these patients with craniosynostosis will not differ from normal, nor from the current
      standard of care.

      In order to reconstruct, reshape, and expand the contours of the deformed craniofacial
      skeleton, large skin incisions and subcutaneous dissections are necessary to allow for
      sufficient exposure during the procedure. These large incisions and dissections are a
      necessary part of the reconstruction. During the normal course of the procedure, temporalis
      muscle, a muscle of mastication in the temporal area, and subcutaneous adipose will be
      visible and exposed. It is only after the plastic surgeon has obtained this standard exposure
      that excisional biopsies of a maximum size of 2mm X 2mm X 3mm will be taken from consented
      patients. Bone samples will be collected from bone tissue that would normally be discarded
      during the reconstructive surgery, so no additional procedures are needed to collect the bone
      samples. Biopsy samples will not be provided to secondary investigators. The muscle and
      adipose biopsies are research required procedures. At the time of surgery one sample of
      tissue will be taken from temporalis muscle, subcutaneous adipose, and bone. The investigator
      will review the results of the test/procedure that are part of the standard of care and
      results will become part of the research record. The investigators will continue to use and
      disclose identifiable medical information and keep stored tissue samples for seven years.
      After this seven year period, all identifying information will be removed samples will be
      destroyed.

      The muscle and adipose tissue biopsies will take approximately 10 minutes. The samples of
      bone tissue will be discarded as a result of the reconstructive surgery and will, therefore,
      not add any time to the surgical procedure.

      Subjects will not be notified of the results of this study because the results will not
      impact the clinical care of the subject.
    

Intervention name(s): biopsy
Intervention type(s): Other
Intervention description(s): A biopsy of the patient's temporalis muscle, subcutaneous adipose, and bone tissue is the experimental procedure. The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. A very small fragment of each tissue type, 2mm X 2mm X 3mm biopsy, will be removed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples from children with craniosynostosis,; to grow cells from these tissues in vitro; to evaluate the osteogenic potentials of these cell types.