Cranial LOOP

https://neosurgery.com/product/cranial-loop/

• A novel minimally invasive neurosurgical cranial fixation device for improved accuracy of intraventricular catheter placement: an experimental animal study
• Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems
• Use of Clamp-Like Devices to Fix Bifrontal Basal Craniotomies: Three Case Reports
• Simplified modeling of implanted medical devices with metallic filamentary closed loops exposed to low or medium frequency magnetic fields
• The Lateral Orbital Thickening and the Lateral Brow Thickening: A New Choice for the Lower Eyelid Suspension
• Sensor-actuator component for a Floating Mass Transducer-based fully implantable hearing aid
• Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System
• Optimal tether configurations and preload tensioning to prevent proximal junctional kyphosis: a finite element analysis

The Cranial LOOP is an innovative cranial fixation device specifically designed for repositioning and securing bone flaps after a craniotomy. Unlike traditional methods using titanium plates and screws (P&S), this system employs a clamp-like technology made from high-strength polymers.

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• Material: Advanced biocompatible polymers that are lightweight, durable, and well-tolerated by the body.
• Design: A clamp-style mechanism that allows precise alignment and fixation of the bone flap without additional screws.
• Functionality: The device grips the edges of the bone, securing it in place during the healing phase without requiring drilling into the flap or surrounding skull.

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• Less Invasive
  1. Does not require additional drilling into the bone, reducing trauma and the risk of microfractures.
  2. Eliminates the need for screws, simplifying the procedure.
• Ease of Use
  1. Installation is quicker and more straightforward, potentially reducing surgical time.
  2. Frequently described as “easy” or “very easy” by surgeons in various studies, indicating a minimal learning curve.
• Patient Comfort
  1. Unlike plates and screws, the device does not cause protrusions or discomfort beneath the skin, as reported by patients.
• Cost Efficiency
  1. Fewer components are needed (e.g., no screws), which could lower overall costs while maintaining effectiveness.
• Aesthetic and Functional Outcomes
  1. Provides secure fixation with excellent bone flap alignment, comparable to traditional methods, while minimizing patient-reported inconveniences.

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• Long-term Data Needed
  1. While short- to medium-term outcomes are promising, further studies are required to evaluate long-term performance, including resistance to reabsorption and stability over years.
• Specific Indications
  1. May not yet be validated for all types of craniotomies or complex cases, such as those involving bone defects or revision surgeries.
• Surgeon Familiarity
  1. Adoption may be slower in institutions where P&S systems are deeply ingrained in practice.

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• Standard craniotomies where stable bone flap fixation is needed.
• Procedures requiring minimal postoperative discomfort or aesthetic concerns.
• Cases where rapid surgical workflows are prioritized.

The Cranial LOOP represents a safe, effective, and potentially cost-efficient alternative to traditional cranial fixation systems. With benefits such as ease of use, reduced invasiveness, and enhanced patient comfort, it offers significant promise in neurosurgical practice. However, more extensive trials with long-term follow-up are essential to fully establish its role as a mainstream solution for craniotomy closure.

A randomized controlled trial compares the clinical safety and performance of clamp-like devices with the standard of care for craniotomy closure: titanium plates and screws (P&S).

Methods: A prospective, double-arm, multicenter randomized controlled trial was performed at 3 sites, recruiting 60 patients undergoing neurosurgical interventions requiring craniotomy. Patients were randomly allocated to 2 groups depending on the bone flap fixation system to be used: plates and screws (any brand) and clamp-like devices (Cranial LOOP, NEOS Surgery S.L.). The primary end point of the study (bone flap alignment) was assessed 6 months after surgery through neuroimaging. Secondary end points included adverse events and device deficiency assessment, closure method usability assessed by the surgeon, and patient-reported device-related inconveniences.

Results: It was necessary to use a median of 3 Cranial LOOP and 4 plates and 8 screws to close craniotomies. All patients from both groups had equally good bone flap alignment. Most implantations were reported as easy or very easy for both groups, and surgeons were generally satisfied or very satisfied with both treatments. No related adverse events have been reported for any of the treatment groups. Two patients reported discomfort or protuberances caused by P&S; no inconveniences were reported for Cranial LOOP.

Conclusion: Cranial LOOP performance is equal to P&S for fixation of the cranial bone flap. In addition, it presents some advantages, such as the use of a lower number of devices, potentially making this system more affordable, and the lack of discomfort previously linked with the use of P&S ¹⁾.

Strengths of the Study Robust Study Design

The use of a prospective, multicenter randomized controlled trial (RCT) design is a gold standard for evaluating medical devices. Random allocation reduces bias, while the multicenter approach increases external validity and generalizability. Clear and Relevant Endpoints

The study’s primary endpoint—bone flap alignment assessed via neuroimaging at 6 months—is clinically relevant as it directly reflects the success of cranial fixation. Secondary endpoints such as adverse events, usability, and patient-reported outcomes provide a comprehensive evaluation of the devices. Innovative Device Assessment

This trial provides much-needed evidence on alternative fixation methods, particularly Cranial LOOP, which aims to address limitations of traditional P&S systems, including patient discomfort and hardware bulkiness. Promising Results

The findings indicate that Cranial LOOP achieves comparable outcomes in bone flap alignment, with no reported adverse events. Moreover, the system demonstrates advantages in terms of fewer devices required and improved patient comfort, with no discomfort or protuberances reported. Surgeon Usability Feedback

The subjective assessment of ease of use and satisfaction by surgeons adds valuable practical insights into the feasibility of adopting Cranial LOOP in clinical settings. Limitations and Criticisms Sample Size

The study includes only 60 patients, limiting its statistical power. While the findings are encouraging, this small sample may not capture rare complications or variations in outcomes across diverse patient populations. Short Follow-Up Period

The 6-month follow-up period is insufficient to assess long-term complications such as bone resorption, device migration, or delayed adverse events. Longer follow-up would be necessary to fully evaluate the durability and safety of Cranial LOOP compared to P&S. Lack of Subgroup Analysis

The study does not provide data on how the devices perform in specific subgroups, such as patients with thin skulls, complex craniotomies, or those undergoing revision surgeries. Such data would help refine the indications for Cranial LOOP. Economic Evaluation

Although the authors suggest that Cranial LOOP may be more affordable due to fewer devices being required, the study does not include a detailed cost analysis. Comprehensive cost-effectiveness data, including device costs, surgical time, and potential long-term savings, would strengthen this claim. Subjective Measurements

While surgeon satisfaction and usability ratings are important, they are inherently subjective and susceptible to bias. Blinding surgeons to the type of device (e.g., by having independent evaluators assess outcomes) might have reduced bias. Geographic and Institutional Bias

The trial was conducted at only three centers, two in Spain and one in Slovenia. The limited geographic scope may not reflect surgical practices or patient populations in other regions. Clinical Implications Potential Advantages of Cranial LOOP

Fewer devices required: The median use of 3 Cranial LOOP devices versus 4 plates and 8 screws simplifies the surgical process, potentially reducing operative time and costs. Improved patient comfort: The absence of patient-reported discomfort or protuberances is a significant advantage, particularly in cases where aesthetics or long-term comfort are priorities. Ease of adoption: The positive usability feedback suggests that Cranial LOOP could be easily integrated into surgical workflows without extensive training. Unanswered Questions

The study does not address specific scenarios where Cranial LOOP might be preferred over P&S, such as pediatric cases, complex cranial reconstructions, or patients with hardware allergies. Next Steps in Research

Larger, multicenter studies with long-term follow-up are needed to confirm these findings and evaluate outcomes like bone integrity, durability, and rare complications. A cost-effectiveness analysis would help determine whether Cranial LOOP is a viable economic alternative in different healthcare systems. Conclusion This study makes a valuable contribution to the field by demonstrating that Cranial LOOP is a safe and effective alternative to titanium plates and screws for cranial fixation. Its advantages, including fewer devices needed and improved patient comfort, highlight its potential for broader adoption. However, the small sample size, short follow-up, and lack of cost analysis limit the strength of the conclusions. Future studies should address these gaps to establish Cranial LOOP’s long-term efficacy and economic viability.