Head Fixation Devices in Neurosurgery: A Systematic Review and Meta-Analysis.

Background: Head fixation is a crucial step in neurosurgical practice, significantly impacting surgical precision, ergonomics, and complication rates. This study aims to compare complication profiles between the Mayfield and Sugita systems and to evaluate the proportional incidence of each complication.

Methods: Following PRISMA-2020, PubMed and Scopus were searched for human neurosurgical studies reporting complications of the Mayfield or Sugita cranial fixation systems (PROSPERO CRD420251105349). Meta-analyses (random-effects) were generated for skull fracture, epidural hematoma, vascular or nerve injury, and head slippage; heterogeneity (I) and sensitivity analyses were undertaken in Jamovi v2.4.

Results: Seventeen studies involving 1938 patients met inclusion criteria. In crude estimates, the Sugita frame was used in 1048 procedures (54.1%), the Mayfield clamp in 815 (42.0%), and pin-less supports in 7 (0.4%). Overall complication rates were low: skull fracture 1.2%, epidural hematoma 1.0%, vascular injury 0.6%, head slippage 0.2%, pin-site infection 0.2%, and one nerve injury. Meta-analysis found no significant differences between systems for skull fracture (odds ratio [OR] 1.26, 95% CI 0.12-12.9), epidural hematoma (OR 1.40, 0.14-14.0), vascular injury (OR 1.94, 0.19-19.7), nerve injury (OR 2.46, 0.23-26.4) or slippage (OR 2.21, 0.18-27.0); all P≥0.45. Sensitivity analysis eliminated heterogeneity for skull fracture (I 0%), and age did not moderate any outcome.

Conclusion: Major complications were rare (∼1%) and did not differ between Mayfield and Sugita clamps. Fixation safety hinges on the precise application of pin torque and bone quality, rather than device type; therefore, torque-standardized prospective studies are now warranted.