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Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects

NCT02828306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2019-09-04

No results posted yet for this study

Summary

Patients with skull defects after craniotomy for example tumor resection, head trauma, stroke, need a reimplantation of the bone afterwards. For some circumstances, their own bone cannot be reimplanted due to infection, tumor infiltration, damage to the bone, or aseptic bone necrosis. In these cases a Patient Specific Implant (PSI) needs to be designed to fit into the patient's skull defect.

The design of the PSI is based on the preoperative CT-scan of the patient's head with the skull defect, the imaging data set is uploaded and processed with IPlanNet software by BrainLab®. With the help of the software, a 3D model of a negative mould of the PSI is designed and printed. In the operation room, the PSI is fabricated under sterile conditions using the PSI mould. The design of the PSI mould with the help of IPlanNet is demanding and takes some few hours depending on the complexity of the case to be designed. In certain cases the accuracy of the fabricated PSI mould is not optimal, so that the surgeon intraoperatively has to adapt for the inaccuracy to achieve the best cosmetic and functional results at the expense of the operation duration, a known risk factor for postoperative wound infection and other perioperative complications.

Therefore, the investigators have developed an automated computer-based algorithm for PSI design (CAPSID). With the help of this tool, an accurate PSI and its corresponding mould can be calculated and designed based on the preoperative CT scan of the patient within 5-15 minutes and the corresponding mould can be printed. This step is automated and thus, independent of the neurosurgeons experience and skills in 3D processing software. The mould can be used for intraoperative fabrication of the implant under sterile conditions in the common way as described above. The possible advantages of the clinical establishment of this procedure would be a higher accuracy of the PSI compared to the conventional PSI fabrication method with better cosmetic results, lower costs and faster availability and production leading to shorter waiting time for the patient, and as a consequence of the higher accuracy leading to shorter operation time, with a reduction of risk of operative adverse events for the patient. Furthermore, the proof of practicability of this new method, could lead to new concepts in the field of Computer-based Patient Specific Implants in modern medicine in general.

Conditions

Interventions

OTHER

Patient Specific Implant

Implantation of Patient Specific Implant

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Philippe Schucht, MD · University Hospital Inselspital

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-06-30
Completion
2019-08-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828306 on ClinicalTrials.gov