Clinical trial NCT02828306: Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects
Official title: Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects: a Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Head Trauma
Keywords: stroke
head trauma
Patient Specific Implant
skull defect
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with skull defects after craniotomy for example tumor resection, head trauma, stroke, need a Patient Specific Implant (PSI).

Brief 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.

Detailed description: 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. Several materials are currently used such as titanium, poly-ether-ether-ketone (PEEK) or poly-methylmethyl-acrylate (PMMA) for PSI fabrication. At the moment, PSI are commercially available from different companies (DePuy Synthes®, EOS®, Xilloc®). Apart from the high costs of commercially available PSI, it takes usually several weeks until the designed and manufactured PSI is delivered to the hospital ready for reimplantation.

On the other hand, a method for software-based PSI design and intraoperative fabrication of the PSI under sterile conditions was described by Stieglitz et al. This method is currently used in everyday clinics in the department of neurosurgery in Bern. In short summary, 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. A clinical trial is necessary to proof the advantages and practicability of the investigators' concept of computer-based algorithm for PSI design (CAPSID) for patients with skull defects.

Eligibility criteria: Inclusion Criteria:

* Patients with skull defects due to craniotomy who need a Patient Specific Implant (PSI) of the skull
* Age older than 18 and less than 90 years
* Provided written informed consent

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Palacos
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known coagulopathy
* Severe disease with limited life expectancy of less than one year

Primary outcomes:
measure: Number of patients where there is no need to adapt the PSI's edges
timeFrame: 6 weeks after surgery by standardised questionnaire
measure: Number of patients where there is no need to augment/fill clefts between the PSI and patient´s bone
timeFrame: 6 weeks after surgery by standardised questionnaire
measure: Number of patients where there is no need to discard the PSI and fabricate a new PSI
timeFrame: 6 weeks after surgery by standardised questionnaire
Secondary outcomes:
measure: Operation duration
timeFrame: intraoperative
measure: Patient's satisfaction measured by questionary
timeFrame: 6 weeks
measure: infection rate
timeFrame: day 1-3 after OP, at 6 weeks
measure: postoperative haemorrhage
timeFrame: day 1-3 after OP, at 6 weeks
measure: postoperative cerebrospinal fluid leakage
timeFrame: day 1-3 after OP, at 6 weeks
measure: PSI-displacement
timeFrame: day 1-3 after OP, at 6 weeks
measure: need for reoperation
timeFrame: day 1-3 after OP, at 6 weeks
measure: Accuracy of the PSI determined by volumetric analysis of the patient´s post-implantation CT scan (dice similarity index)
timeFrame: 3 days after surgery
measure: Accuracy of the PSI determined by volumetric analysis of the patient´s post-implantation CT scan (volumetric inaccuracy index)
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Neurosurgery, Bern University Hospital
Study officials:
affiliation: University Hospital Inselspital
name: Philippe Schucht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Della Puppa A, Rustemi O, Gioffre G, Troncon I, Lombardi G, Rolma G, Sergi M, Munari M, Cecchin D, Gardiman MP, Scienza R. Predictive value of intraoperative 5-aminolevulinic acid-induced fluorescence for detecting bone invasion in meningioma surgery. J Neurosurg. 2014 Apr;120(4):840-5. doi: 10.3171/2013.12.JNS131642. Epub 2014 Jan 10.
citation: Lassen B, Helseth E, Ronning P, Scheie D, Johannesen TB, Maehlen J, Langmoen IA, Meling TR. Surgical mortality at 30 days and complications leading to recraniotomy in 2630 consecutive craniotomies for intracranial tumors. Neurosurgery. 2011 May;68(5):1259-68; discussion 1268-9. doi: 10.1227/NEU.0b013e31820c0441.
citation: Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J. What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24.
citation: Chim H, Gosain AK. Biomaterials in craniofacial surgery: experimental studies and clinical application. J Craniofac Surg. 2009 Jan;20(1):29-33. doi: 10.1097/SCS.0b013e318190dd9e.
citation: Stieglitz LH, Gerber N, Schmid T, Mordasini P, Fichtner J, Fung C, Murek M, Weber S, Raabe A, Beck J. Intraoperative fabrication of patient-specific moulded implants for skull reconstruction: single-centre experience of 28 cases. Acta Neurochir (Wien). 2014 Apr;156(4):793-803. doi: 10.1007/s00701-013-1977-5. Epub 2014 Jan 18.