Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System
C. Asencio, L. Salgado, F. Muñoz, C. De Quintana, R. Rodríguez, MJ. Álvarez, G. Conesa
This is an observational, retrospective, case series study of 60 patients who underwent a craniotomy and were subject to cranial bone flap fixation with the Cranial LOOP fixation system. Baseline clinical parameters, surgical variables, medical records, and all postoperative medical images available were reviewed to assess the bone flap alignment and potential adverse events.
A total of 182 Cranial LOOPs were implanted and the system maintained a good bone flap alignment in 95% of the patients studied immediately after surgery and in up to 96.7% of them at the end of follow-up. No intraoperative complications were reported. An ulcer potentially related to a device was detected, which was solved without the need for device removal. No artifacts were observed in any of the 219 medical images analyzed.
Conclusion: Cranial LOOP is a safe and reliable postoperative long-term cranial bone flap fixation system. This device can fix the bone flap after a wide range of craniotomy procedures, performed in multiple locations, and provides good bone flap alignment. Cranial LOOP does not interfere in patient follow-up through medical imaging.
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 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.