title: Skull bone flap fixation - reliability and efficacy of a new grip-like titanium device (Skull Grip) versus traditional sutures: a clinical randomized trial.
abstract: BACKGROUND
  After completing a craniotomy, it is important to replace the removed bone flap in its natural position in order to guarantee brain protection as well as improve cosmesis. A skull defect can expose the brain to accidental damage, and in cases of larger defects it may also cause the patients psychosocial problems. The ideal fixation device should provide reliable attachment of the flap to the skull and promote fast bony healing to avoid possible pseudo-arthrosis and/or osteolytic changes.
  
  
  METHODS
  This is a pilot randomized clinical trial on a series of 16 patients undergoing different craniotomies for benign brain lesions in which the bone flaps were replaced using traditional sutures (Prolene 0.0) in 8 cases and with a new skull fixation device (Skull Grip) in the other 8 (randomly allocated). All patients underwent CT scans of the head with 3D reconstruction at day 1 and day 90 postoperatively to evaluate bone flap position and fusion. These scans were independently reviewed by a neuroradiologist. Cosmesis was also evaluated clinically by the surgeon and radiologically by the neuroradiologist in the 2 patient groups.
  
  
  RESULTS
  The new "Skull Grip" device has shown stronger fixation qualities with optimal bone flap fusion and increased cosmetic healing features vs. traditional sutures.
  
  
  CONCLUSIONS
  The "Skull Grip" has shown to be a reliable, effective and stronger bone flap fixation device when compared to traditional sutures.
authors.affiliation: Department of Neurosurgery, Service de Neurochirurgie, Hopital Lariboisière, 75475 Paris Cedex 10, France. schibbaro@hotmail.com
authors.forename: S
authors.initials: S
authors.lastname: Chibbaro
authors.forename: O
authors.initials: O
authors.lastname: Makiese
authors.forename: D
authors.initials: D
authors.lastname: Bresson
authors.forename: S
authors.initials: S
authors.lastname: Hamdi
authors.forename: J F
authors.initials: JF
authors.lastname: Cornelius
authors.forename: J P
authors.initials: JP
authors.lastname: Guichard
authors.forename: A
authors.initials: A
authors.lastname: Reiss
authors.forename: S
authors.initials: S
authors.lastname: Bouazza
authors.forename: E
authors.initials: E
authors.lastname: Vicaut
authors.forename: A
authors.initials: A
authors.lastname: Ricci
authors.forename: R
authors.initials: R
authors.lastname: Galzio
authors.forename: P
authors.initials: P
authors.lastname: Poczos
authors.forename: B
authors.initials: B
authors.lastname: George
authors.forename: M
authors.initials: M
authors.lastname: Marsella
authors.forename: P
authors.initials: P
authors.lastname: Di Emidio
mesh_terms: D000368:Aged; D001932:Brain Neoplasms / Q000601:surgery; D003399:Craniotomy / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D015203:Reproducibility of Results; D012886:Skull / Q000601:surgery*; D013524:Surgical Flaps; D013525:Surgical Instruments; D013536:Suture Techniques / Q000295:instrumentation*; D013537:Sutures; D014025:Titanium; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D014025:Titanium