Complications of Head Immobilization Devices in Children: Contact Mechanics, and Analysis of a Single Institutional Experience

Zaazoue, Mohamed A.; Bedewy, Mostafa; Goumnerova, Liliana

doi:10.1093/neuros/nyx315

Cited by 10 publications

(29 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Due to the design of common HFD, skull fractures predominantly occur on the single-pin side if pinning force is escalated whereas the displacement of pins occurs on the 2-pin side if pinning force is insufficient. These accidents are multifactorial, including failure of the contact mechanics, the pinning technique, and the patient's history [23]. In 2016, the US Food and Drug Administration (FDA) circulated a safety communication pointing out the scientific neglect of complications leading to the skull and facial injuries [18].…”

Section: Introductionmentioning

confidence: 99%

Respond of the different human cranial bones to pin-type head fixation device

Dooren

Mertens³

et al. 2021

Acta Neurochir

View full text Add to dashboard Cite

Background At this juncture, there is no consensus in the literature for the use and the safety of pin-type head holders in cranial procedures. Methods The present analysis of the bone response to the fixation of the instrument provides data to understand its impact on the entire skull as well as associated complications. An experimental study was conducted on fresh-frozen human specimens to analyze the puncture hole due to the fixation of each single pin of the pin-type head holder. Cone-beam CT images were acquired to measure the diameter of the puncture hole caused by the instrument according to several parameters: the pin angle, the clamping force, and different neurosurgical approaches most clinically used. Results The deepest hole, 2.67 ± 0.27 mm, was recorded for a 35° angle and a clamping force of 270 N at the middle fossa approach. The shallowest hole was 0.62 ± 0.22 mm for the 43° angle with a pinning force of 180 N in the pterional approach. The pterional approach had a significantly different effect on the depth of the puncture hole compared with the middle fossa craniotomy for 270 N pinning at 35° angle. The puncture hole measured with the 43° angle and 180 N force in prone position is significantly different from the other approaches with the same force. Conclusions These results could lead to recommendations about the use of the head holder depending on the patient’s history and cranial thickness to reduce complications associated with the pin-type head holder during clinical applications.

show abstract

Section: Introductionmentioning

confidence: 99%

Respond of the different human cranial bones to pin-type head fixation device

Dooren

Mertens³

et al. 2021

Acta Neurochir

View full text Add to dashboard Cite

show abstract

“…To test the model, we ran two FEM simulations corresponding to 1.58 and 12.17 years of age. These specific ages were selected to correspond to actual ages in case studies encountered by the authors [12]. The schematic for the cases as well as the resulting axial force vs. penetration as well as well the lateral stiffness vs. applied axial force are shown in Figure 9.…”

Section: Resultsmentioning

confidence: 99%

“…This is reflected in the variability of clamping force for each age range in the same survey. This problem was also emphasized in our work [12], however, the lack of available data prevented a reliable set of guidelines to be created and enforced. In this paper, we discuss the risk factors attributed to pin-type HIDs through a root cause analysis of possible complications.…”

mentioning

confidence: 94%

“…However, the actual published pediatric complications in the literature are much less than that, which clearly indicates that this is a common, yet under-reported problem, [2][3][4][6][7][8][9][10][11]. In our previous work in which we reviewed HID related complications in one institution, we found that these injuries occurred more with pediatric cases rather than adults, and identified other medical conditions such as hydrocephalus for cases we reviewed [12]. Recently, the U.S. Food and Drug Administration (FDA) has issued a safety communication, [13] stating that it has received more than 1,000 medical device reports (MDRs) associated with HID-related adverse events, during the period between January 2009 and January 2016, resulting in more than 700 injuries.…”

mentioning

confidence: 98%

See 1 more Smart Citation

Biomechanical Root Cause Analysis of Complications in Head Immobilization Devices for Pediatric Neurosurgery

Abdulhafez

Kadry

Zaazoue

et al. 2018

Volume 1: Additive Manufacturing; Bio and Sustainable Manufacturing

Self Cite

View full text Add to dashboard Cite

Precise and firm fixation of the cranium is critical during craniotomy and delicate brain neurosurgery making head immobilization devices (HIDs) a staple instrument in brain neurosurgical operations today. However, despite their popularity, there is no standard procedure for their use and many complications arise from using HIDs in pediatric neurosurgery. In this paper, we identify biomechanical causes of complications and quantify risks in pin-type HIDs including clamping force selection, positioning and age effects. Based on our root cause analysis, we develop a framework to address the biomechanical factors that influence complications and understand the biomechanics of the clamping process. We develop an age-dependent finite element model (FEM) of a single pin on a cranial bone disc with the representative properties and skull thickness depending on age. This model can be utilized to reduce risk of complications by design as well as to provide recommendations for current practices.

show abstract

“…In fact, the US Food and Drug Administration in 2016 urged caution with neurosurgical head holders due to slippage, based on reports of 1000 slippages with 700 injuries. 2 Some reports have associated skull hematomas, 3 fractures, 4,5 air embolism, 6 and asystole 7 as complications of pinned head holders. However, the reasons for slippage have not been addressed and few reports have described head slippage, despite 700 associated injuries.…”

Section: Introductionmentioning

confidence: 99%

<p>Estimation of Risk Factors for Head Slippage Using a Head Clamp System. A Retrospective Study</p>

Sakakura¹,

Fujimoto²,

Ichikawa³

et al. 2020

TCRM

View full text Add to dashboard Cite

Background: Although complications have been associated with head clamp systems, few reports have described head slippage. The present study aimed to determine risk factors for head slippage and speculated that the position of head holder pins might be associated. Patients and Methods: We reviewed medical records and compared the positions of the pinned heads of patients on fused preoperative and postoperative computerized tomography (CT) images. We measured the distance between corresponding head pins to determine head slippage. Age, sex, body weight, body mass index, surgical position, surgical duration, craniotomy volume, and the relationship between head pins and the nasion-inion (NI) line were statistically compared between patients with and without head slippage. Results: Head slippage in 3 (10%) of 28 patients was significantly associated with the most caudal pin position (p < 0.001) and craniotomy volume (p = 0.036). Receiver operator characteristics curves indicated a cutoff of 4.5 cm from the NI line (sensitivity and specificity, 1.000 and 0.800, respectively). Conclusion: Clamped heads can slip during surgical procedures. We found that one head pin should be located within 4.5 cm from the NI line to avoid head slippage.

show abstract

Complications of Head Immobilization Devices in Children: Contact Mechanics, and Analysis of a Single Institutional Experience

Cited by 10 publications

References 17 publications

Respond of the different human cranial bones to pin-type head fixation device

Respond of the different human cranial bones to pin-type head fixation device

Biomechanical Root Cause Analysis of Complications in Head Immobilization Devices for Pediatric Neurosurgery

<p>Estimation of Risk Factors for Head Slippage Using a Head Clamp System. A Retrospective Study</p>

Contact Info

Product

Resources

About