Osteogenic Profiling of Normal Calvarial Bone

For outpatient study recruitment, the research coordinator will review the clinic schedule for potential study candidates. Any patient schedule for a pre-op appointment for surgical calvarial reconstruction will be considered a possible study candidate. The research coordinator will then e-mail the study team the list of potential study candidates with the date and time of the appointment or in-patient study recruitment, the screening procedures include review and collection of information from the patient's medical record-specifically, a physical examination by the plastic surgeon at the Cleft Palate-Craniofacial Center Plastic surgery department. This evaluation will occur either as an inpatient or as an outpatient, depending on the appropriateness and timing of the ultimate surgical repair. During the clinical examination, the plastic surgeon will determine if portions of the skull are unusable for reconstruction. These bone fragments (when too small or shattered to be incorporated into a reconstruction) are normally discarded. It is these fragments alone that will be harvested for evaluation in the present study. The evaluation and surgical repair of these patients requiring post-traumatic reconstruction will not differ from normal, nor from the current standard of care.

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. At the time of surgery one sample of tissue will be taken from 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 tissue samples for seven years. After this seven year period, all identifying information will be removed. Bone marrow tissues will be collected from patients at the time of surgery without any additional dissection or incisions. Bone will be finely minced and then plated in tissue culture flasks as previously reported by other groups.

The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. At the time of surgery one sample of tissue will be taken from otherwise discarded bone.

Samples will be collected and coded by the plastic surgeon/principal investigator before transfer from the operative room to the Pediatric Craniofacial Biology Laboratory.

The research coordinator will notify Dr. Bykowski of when consented subjects are scheduled for surgery via e-mail. Dr. Bykowski will collect the coded sample and transport them to the Pediatric Craniofacial Biology laboratory.