Chibbaro S, Makiese O, Bresson D, Hamdi S, Cornelius J F, Guichard J P, Reiss A, Bouazza S, Vicaut E, Ricci A, Galzio R, Poczos P, George B, Marsella M, Di Emidio P
Department of Neurosurgery, Service de Neurochirurgie, Hopital Lariboisière, 75475 Paris Cedex 10, France.
Minim Invasive Neurosurg. 2011 Oct;54(5-6):282-5. doi: 10.1055/s-0031-1297246. Epub 2012 Jan 25.
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.
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.
开颅手术后，将移除的骨瓣复位到其自然位置很重要，以确保大脑得到保护并改善美观。颅骨缺损会使大脑面临意外损伤的风险，对于较大的缺损，还可能给患者带来心理社会问题。理想的固定装置应能可靠地将骨瓣固定于颅骨，并促进快速骨愈合，以避免可能出现的假关节形成和/或骨质溶解改变。
这是一项针对16例因良性脑病变接受不同开颅手术患者的初步随机临床试验，其中8例患者使用传统缝线（普理灵0.0）复位骨瓣，另外8例（随机分配）使用新型颅骨固定装置（Skull Grip）。所有患者在术后第1天和第90天接受头部CT扫描及三维重建，以评估骨瓣位置和融合情况。这些扫描结果由一名神经放射科医生独立审核。两组患者的美观效果还分别由外科医生进行临床评估以及由神经放射科医生进行影像学评估。
与传统缝线相比，新型“Skull Grip”装置表现出更强的固定性能，骨瓣融合效果更佳，美观愈合特征更明显。
与传统缝线相比，“Skull Grip”已证明是一种可靠、有效且更强的骨瓣固定装置。
