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

NCT02828306 | Completed

• 1 other identifier: CAPSID
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Head Trauma

Keywords

stroke; head trauma; Patient Specific Implant; skull defect

Outcome Measures

Primary Outcomes (3)

• Number of patients where there is no need to adapt the PSI's edges

  6 weeks after surgery by standardised questionnaire

• Number of patients where there is no need to augment/fill clefts between the PSI and patient´s bone

  6 weeks after surgery by standardised questionnaire

• Number of patients where there is no need to discard the PSI and fabricate a new PSI

  6 weeks after surgery by standardised questionnaire

Secondary Outcomes (9)

• Operation duration

  intraoperative

• Patient's satisfaction measured by questionary

  6 weeks

• infection rate

  day 1-3 after OP, at 6 weeks

• postoperative haemorrhage

  day 1-3 after OP, at 6 weeks

• postoperative cerebrospinal fluid leakage

  day 1-3 after OP, at 6 weeks

Study Arms (1)

Patients with skull defects

Patients with skull defects after craniotomy for example tumor resection, head trauma, stroke which need a Patient Specific Implant.

Other: Patient Specific Implant

Interventions

Patient Specific Implant OTHER

Implantation of Patient Specific Implant

Patients with skull defects

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 24410157 BACKGROUND

• 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.

  PMID: 21273920 BACKGROUND

• 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.

  PMID: 25534126 BACKGROUND

• 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.

  PMID: 19164984 BACKGROUND

• 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.

  PMID: 24442601 BACKGROUND

MeSH Terms

Conditions

Stroke; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Philippe Schucht, MD

  University Hospital Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 11, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)