Skull Bone Flap Fixation – Reliability and Efficacy of a New Grip-Like Titanium Device (Skull Grip) versus Traditional Sutures: A Clinical Randomized Trial
25 January 2012 (online)
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.
Materials and 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.
The new “Skull Grip” device has shown stronger fixation qualities with optimal bone flap fusion and increased cosmetic healing features vs. traditional sutures.
The “Skull Grip” has shown to be a reliable, effective and stronger bone flap fixation device when compared to traditional sutures.
- 1 Frenzel D, Lerch K-D. CranioFix titanium clamp for refixation of cranial bone flaps: Clinical long-term results in comparison with suture material. Zentralbl Neurochir Suppl 1998; 24 (abstr)
- 2 Spetzler RF. Bone flap fixation. A new technique. J Neurosurg 1997; 87: 475-476
- 3 Lerch K-D. Stereotactically guided microsurgical resection of deepseated brain lesions: Minimization of established and development of new unconventional approaches. Minim Invas Neurosurg 1995; 38: 60-78
- 4 Lerch K-D, Schäfer D. Stereotactic microresection of deep-seated small cerebral vascular malformations. Acta Neurochir 1994; 130: 28-34
- 5 Lerch KD, Morgenstern F, Lau KT et al. Rivet-like titanium clamps for refixation of bone covers after craniotomy − radiologic identification, safety and image quality in CT and MR studies. Rofo 1998; 169: 601-604 [in German]
- 6 Winston KR, Wang MC. Cranial bone fixation: review of the literature and description of a new procedure. J Neurosurg 2003; 99: 484-488
- 7 Di Lorenzo N, Mouchaty H, Shamsaldin M et al. Cranial bone flap fixation with microplates and screws: a new application technique. Technical note. J Neurosurg Sci 2004; 48: 55-56
- 8 Perez-Sanchez X, Umansky F, Margolin E et al. Fronto-orbital craniotomy reconstruction using the titanium clamp (Craniofix): a technical note. Surg Neurol 2006; 65: 51-54
- 9 Wilkinson HA. Cranial bone fixation. J Neurosurg 2004; 100: 1134-1135 author reply 1135
- 10 Paolini S, Ciappetta P. Pericranial flap fixation using titanium miniplates and screws. Br J Neurosurg 2003; 17: 65-66
- 11 Estin D, Troffkin N, Heilman CB. Bone flap fixation with titanium clamps: a new technique. Surg Neurol 2000; 53: 391-394; discussion 394–395
- 12 New PFL, Rosen BR, Brady TJ. Potential hazards and artifacts of ferromagnetic and nonferromagnetic surgical and dental materials and devices in nuclear magnetic resonance imaging. Radiology 1983; 147: 139-148
- 13 Shellock FG, Shellock VJ. Cranial bone flap fixation clamps: Compatibility at MR imaging. Radiology 1998; 207: 822-825
- 14 Shellock FG, Morisoli S, Kanal E. MR procedures and biomedical implants, materials and devices: 1993 update. Radiology 1983; 189: 587-599
- 15 Chibbaro S, Makiese O, Mirone G et al. Skull bone flap fixation − comparative experimental study to assess the reliability of a new grip-like titanium device (Skull Grip) versus traditional sutures: technical note. Minim Invas Neurosurg 2009; 52: 98-100
- 16 Winston KR, Wang MC. Cranial bone fixation in infants and children. Pediatr Neurosurg 1999; 31: 225-230