Cranial LOOP cranial fixation devices are a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps resulting from craniotomies.

It is completely instrument-free due to its fast and easy ‘Pull and tighten’ action, which allows the surgeon to fixate a standard bone flap in less than a minute with only three devices, thus achieving optimal stability and excellent esthetic results. The Cranial LOOP devices produce equivalent fixation strengths to those of other standard metallic fixation devices. The product comes sterile and ready to use.

Cranial Bone Flap Fixation using a New Device (Cranial LOOP)

K. Van Loock, T. Menovsky, N. Kamerling, D. De Ridder

This paper reports the results of cranial bone flap fixation using Cranial LOOP in 35 consecutive patients. These patients were operated by a single surgeon, and the Cranial LOOP products were used for bone flap fixation.

All patients had a postoperative CT scan and a follow-up period of at least 9 months. In all patients, the bone flap could be easily fixed with three or more Cranial LOOP without difficulties or material breakage, within 3 minutes. The postoperative infection rate was 0% and postoperative hemorrhage (either epi/sub or intraparenchymatous) requiring reoperation was 0%. None of the patients experienced a bone flap dislocation, either clinically or on the postoperative CT images. 3D CT scanning revealed all of the flaps were in a good anatomic position.

Conclusion: Cranial LOOP is a very fast, easy and safe to use bone flap fixation device with the main advantage of the absence of artifacts on postoperative CT or MR imaging and lack of cosmetic disadvantage.

Comparison Between Clamp-Like PEEK-Based And Titanium-Based Cranial Bone Flap Fixation Systems

A. Ortega-Rodriguez, C. de Quintana-Schmidt, F. Muñoz-Hernandez, R. Rodriguez-Rodriguez, I. Catala-Antunez, C. Asencio-Cortes, A. Leidinger, M.J. Alvarez-Holzapfel, L. Salgado-Lopez, J. Molet-Teixido.

80 patients with a 12 month follow up to compare the performance (based on surgeon evaluation and possible complications) of a PEEK-based cranial fixation system, Cranial LOOP, and homologous clamp-like titanium-based devices.

Three aspects were evaluated: ease of use of the devices, adaptation to cranial surface and satisfaction with the achieved fixation. Also, for one year during clinical follow-up, the appearance of complications associated to the devices (pain, infection, skin ulcers and flap mobility) were monitored. Satisfaction results show a high approval for both cranial fixation systems. No imaging artefacts (on CT scan and MRI) were observed with the PEEK-based fixation system, while minor distortions appeared with the titanium-based devices.

Conclusion: Both cranial fixation systems provide satisfactory results in the operating room and no complications related with the devices have appeared during follow-up of the patients.

Comparison between PEEK and Titanium cranial fixation devices: load‐bearing properties, artefacts in medical imaging and radiation shielding

F. X. Vilana, M. Charles‐Harris, S. Llas, L. Chico

This study compares the properties of two frequently used titanium cranial fixation systems and the 100% PEEK device Cranial LOOP. The effect of the materials on load‐bearing properties, artefacts created in medical imaging techniques and shielding of radiation in radiotherapy is analyzed. Even when the less favorable case is considered, Cranial LOOP shows a mechanical performance equivalent to that of its titanium counterparts. Regarding medical imaging, Cranial LOOP produces less artefacts and distortions than the titanium devices. The effects of the PEEK and titanium devices on radiation attenuation are equivalent.

Conclusion: Non‐metallic materials, such as polymers, ceramics and composites, can present advantages compared to metals in medical implants: tissue‐friendly mechanical properties, less artefacts, etc. Cranial LOOP is an example of this trend, by achieving equivalent functionality with advantages in medical imaging.