Michael Wehmöller

Individual Prefabricated Titanium Implants in Reconstructive Craniofacial Surgery: Clinical and Technical Aspects of the First 22 Cases

&NA; The reconstruction of craniofacial bone defects by intraoperative modeling of implants restricts the choice of material and its biocompatibility and also reduces the predictability of the aesthetic result. These shortcomings go hand in hand with a prolonged surgical procedure time and increased stress on the patient. In contrast, modern industrial computer‐aided design and computer‐aided manufacturing systems allow the prefabrication of titanium implants, i.e., individual computer‐based three‐dimensional models of the bone defect are generated after acquisition, transfer, and evaluation of helical computed tomographic data. Based on these data, the individual shape of the implant is designed using freeform‐surfaces geometries and is fabricated by a numerically controlled milling machine in a direct fashion. The conical margins of this implant are designed with a precision of 0.25 mm to the borders of the defect, and the surface contours are generated harmonically to the nonaffected neighboring contours with a constant thickness of 1.5 mm. Individual constructions for fixation with the dimensions of microplates are integrated in this process if screw holes cannot be drilled in thin overlapping implant margins. The reconstruction of 22 posttraumatic, postoperative, or primary cranial and craniofacial defects measuring up to 18 cm was performed using this new method. Wound healing was uneventful in all but one case, although some of the patients had been operated on several times before. The result was always predictable and constant using this highly precise technique, and duration of surgery was reduced dramatically. (Plast. Reconstr. Surg. 102: 300, 1998.)

Reconstruction of craniofacial bone defects with individual alloplastic implants based on CAD/CAM-manipulated CT-data

Reconstruction of craniofacial bone defects by intraoperative modelling of autogenous or alloplastic materials may cause undesirable results concerning the implant shape or the long-term maintenance of this shape. Furthermore, the use of alloplastic materials to be modelled intraoperatively may result in an inflammatory tissue response. Therefore the question is raised whether CAD/CAM-techniques may be used for the pre-operative geometric modelling of the implant based on helical computed tomography data. A numerically based 3-dimensional model of the skull defect serves as the basis for a freeform-surfaces design of the implant shape, position and thickness, using modelling tools and programmes developed for industrial CAD/CAM. The precise and individual fit of the implant results from generating its margins by the borders of the defect, whereas the implant surface is generated by the geometry of the non-affected neighbouring bone contours. The implant data run a numerically controlled milling machine to fabricate the individual implant. The reconstruction of post-traumatic defects of the forehead, of post-surgical temporal defects after intracranial haemorrhage, and of a parieto-occipital defect due to ablative tumour surgery are presented as the first clinical experiences of this new method.

Single-step fronto-orbital resection and reconstruction with individual resection template and corresponding titanium implant: a new method of computer-aided surgery

In the cranio-maxillofacial field, computer-aided surgery based on computed tomography (CT) data is becoming more and more important. Navigation systems, which allow the precise intraoperative orientation of surgical instruments, can be used for greater accuracy in determining resection margins of tumours. These techniques support ablative procedures very well, but defect reconstruction still remains a problem. In contrast, computer-aided design (CAD) and computer-aided manufacturing (CAM) systems allow the construction and fabrication of individual templates for bone resection based on coherent numerical 3-D models. The template determines the exact pathway of an oscillating saw so that the planned extent of the resection and, if necessary, also the orientation of the cutting plane are verified. An individual titanium implant is prefabricated with a geometry fitting to that of the template. This implant closes the bone defect so that the contour is reconstructed precisely and individually. This new method was used for the first time for a single-step resection of a meningioma and defect-reconstruction. The tumour which had infiltrated the frontal bone resulting in a protrusion. Fronto-orbital resection and insertion of the titanium implant worked precisely as planned, so that this method offers promising new applications in the field of computer-aided surgery.

CAD by processing of computed tomography data and CAM of individually designed prostheses

In the past an economic fabrication of individual prostheses used in reconstructive cranio-maxillo-facial surgery was not possible due to technical deficiencies. Now, through the consistent use of the most modern computer-based techniques developed in the field of industrial engineering, these costs can be reduced to an economic level. Mathematical freeform surfaces models are first created from helical computed tomography data. These serve as the basis for an efficient and idealized construction of prostheses geometries, and provide control-data for a computerized numerical control-fabrication. In 4 clinical cases this new processing technique has successfully been utilized in the fabrication of individually designed prostheses for the reconstruction of skull defects. The range of opportunities offered is reflected not only in the great variety of possible geometric details, but also in the fact that the prostheses may be manufactured--partly using indirect impression-taking techniques--from 3 different biocompatible materials so far and other applications are likely to turn up.

Synthesis of CAD/CAM, robotics and biomaterial implant fabrication: single-step reconstruction in computer aided frontotemporal bone resection

The preoperative manufacturing of individual skull implants, developed by an interdisciplinary research group at Ruhr-University Bochum, is based on the use of titanium as the most common material for implants at present. Using the existing technology for materials that can be milled or moulded, customized implants may be manufactured as well. The goal of the study was to examine biodegradable materials and to evaluate the practicability of intraoperative instrument navigation and robotics. Data acquisition of an adult sheeps head was performed with helical computer tomography (CT). The data were transferred onto a computer aided design/computer aided manufacturing system (CAD/CAM system), and two complex defects in the frontotemporal skull were designed. Standard individual titanium implants were milled for both of the defects. Additionally, for one of the defects a resection template, as well as a mould for the biodegradable poly(D,L-lactide) (PDLLA) implant, were fabricated by the CAD/CAM system. A surgeon carried out the first bone resection (#1) for the prefabricated titanium implant using the resection template and an oscillating saw. The robot system Stäubli RX90CR, modified for clinical use, carried out the other resection (#2). Both titanium implants and the PDLLA implant were inserted in their respective defects to compare the precision of their fit. A critical comparison of both implant materials and both resection types shows that fabrication of a PDLLA implant and robot resection are already possible. At present, the titanium implant and resection using a template are more convincing due to the higher precision and practicability.

Reconstruction of an extreme frontal and frontobasal defect by microvascular tissue transfer and a prefabricated titanium implant.

: A 30-year-old man was referred to us with an extreme frontal and frontobasal defect from a motorbike accident 12 years before. Multiple attempts at frontal and frontobasal revision and reconstruction had been performed over the years, with several episodes of meningitis. Reconstruction was planned in two steps. First, a revision of the anterior skull base with mobilization of meningeal adhesions and duraplasty, removal of infected masses of polymethylmethacrylate out of the upper ethmoid sinuses, and coverage with a deepithelialized latissimus dorsi free flap were performed. In the second step 3 months later, aesthetic forehead reconstruction was achieved with a pre-fabricated individual titanium implant. The predictable result of this two-step reconstruction was very pleasing. Safe separation of the cranial cavity from the upper airways was essential, requiring free tissue transfer in this case, and is a prerequisite for any alloplastic forehead reconstruction. Timing of the two-step procedure, including the CT data acquisition; handling of soft tissues, bone, and foreign material; and construction details of the implant demonstrate the necessary complex management of this, the most difficult case of the 88 applications of the new computer aided design and manufacturing technique thus far. Even the most elaborate computer aided preparation cannot be successful without consideration of established surgical principles.A 30-year-old man was referred to us with an extreme frontal and frontobasal defect from a motorbike accident 12 years before. Multiple attempts at frontal and frontobasal revision and reconstruction had been performed over the years, with several episodes of meningitis. Reconstruction was planned in two steps. First, a revision of the anterior skull base with mobilization of meningeal adhesions and duraplasty, removal of infected masses of polymethylmethacrylate out of the upper ethmoid sinuses, and coverage with a deepithelialized latissimus dorsi free flap were performed. In the second step 3 months later, aesthetic forehead reconstruction was achieved with a pre-fabricated individual titanium implant. The predictable result of this two-step reconstruction was very pleasing. Safe separation of the cranial cavity from the upper airways was essential, requiring free tissue transfer in this case, and is a prerequisite for any alloplastic forehead reconstruction. Timing of the two-step procedure, including the CT data acquisition; handling of soft tissues, bone, and foreign material; and construction details of the implant demonstrate the necessary complex management of this, the most difficult case of the 88 applications of the new computer aided design and manufacturing technique thus far. Even the most elaborate computer aided preparation cannot be successful without consideration of established surgical principles.

Microsurgical tissue transfer and individual computer-aided designed and manufactured prefabricated titanium implants for complex craniofacial reconstruction.

From 1994 to 2000 187 individual computer-aided prefabricated titanium skull implants were inserted at 37 clinical centres. Since the processing chain of construction and fabrication of implants has become routine the clinical success totally depends on the condition of the soft tissues at the recipient site. In three patients in our own department with a history of up to 18 surgical interventions, and additional previous irradiation in one case, these conditions were so bad that a microsurgical tissue transfer had to be made before insertion of the implant. A latissimus dorsi free flap with submandibular microsurgical anastomosis had to be used in all three cases. However, the aetiology of the soft tissue deficits differed, and they were at a different tissue level in each case: anterior skull base, subcutaneous temporal area, and frontoparietotemporal skin. This series of patients therefore demonstrates the variability of possible combinations, which also require special timetables and principles of construction of the CAD of the implant. In all cases the cranioplasties were done three to five months after the transfer of the flaps and fulfilled the criteria of greatest precision and the best possible aesthetic outcome with minimal stress for the patients. These applications are surgical strategies for extreme cases but also illustrate the elaborate interdisciplinary approach in Computer Assisted Surgery. designed and manufactured (CAD/CAM)

One-step resection and reconstruction of the mandible using computer-aided techniques--experimental and clinical results.

Summary In patients with advanced oral cancer, a resection of the mandible continuity is often indicated. This new method presented here uses computer-aided design and manufacturing (CAD/CAM) for preoperative fabrication of individual mandibular prostheses and their corresponding resection templates in a direct fashion without the need for additional physical models. In this experimental application, a segment of a dried mandible was resected and replaced by a titanium prosthesis prefabricated by CAD/CAM. It was the aim of this investigation to verify the processing chain and its precision, i.e., the fit of an individual implant, such as this. Although this new technique offers fascinating opportunities, possible clinical drawbacks have to be taken into account. Zusammenfassung In Fällen von fortgeschrittenen Mundhöhlenneoplasien besteht häufig die Indikation zur Unterkieferkontinuitätsresektion. Das dargestellte neue Verfahren basiert auf Computer-aided-Design und Manufacturing (CAD/CAM) zur präoperativen Anfertigung von individuellen Implantaten und korrespondierenden Resektionsschablonen durch direkte Herstellung ohne Notwendigkeit zusätzlicher Arbeitsmodelle. In dieser experimentellen Anwendung wurde mit einer in CAD/CAM-Technik hergestellten Resektionsschablone die Segmentresektion eines Leichenunterkiefers und seine simultane Rekonstruktion durchgeführt. Das Ziel dieser Studie war es, die Verfahrenstechnik zu verifizieren und ihre Präzision durch die Paßgenauigkeit eines solchen individuellen Implantats zu überprüfen. Trotz der faszinierenden Möglichkeiten, die diese neue Technik bietet, sollten mögliche klinische Einschränkungen nicht außer acht gelassen werden.

Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000

AbstractObjective The TICC (Tomography, Image processing, CAD, CAM) processing chain developed at the Ruhr-University Bochum in Germany has already been established since several years for the reconstruction of large pre-existing posttraumatic skull defects with individual prefabricated implants made of pure titanium. So far, more than 500 titanium implants have been inserted with great success at more than 60 clinical centres worldwide. The aim of our study was to evaluate all implants inserted between 1994 and 2000. Materials and Methods The study describes the clinical experience with 166 patients receiving 169 skull implants between 1994 and 2000. All 169 implants were measured and categorized in the CAD system in terms of size and anatomical localization. The surgical and radiological reports of the patients were evaluated. Sixty patients operated at the university hospital in Bochum and nearby were clinically reviewed describing scars, position of the implants and cosmetic results. Questionnaires of 131 patients were analyzed regarding the postoperative quality of life distinctly. Results The study shows constantly good to excellent results intraoperatively as well as postoperatively regarding complications, fit of the implants and the clinical follow-up. In particular the enquiry of the patients shows that titanium skull implants improve quality of life. Conclusion High precision and easy handling as well as a low complication rate and the high contentedness of the patients make the individual titanium skull implants valuable for cranioplasty, especially in complicated applications with very large defects, multiple previous operations and additional irradiations. Even in these difficult cases predictable results are possible.

Experimental computer-assisted alloplastic sandwich augmentation of the atrophic mandible.

PURPOSE This study evaluated the effectiveness of a technique that combined computer-aided surgery with alloplastic augmentation and implant-borne prosthodontic rehabilitation of the atrophic mandible. MATERIALS AND METHODS Computed tomographic (CT) data from an atrophic cadaver mandible were transferred to a computer-aided design (CAD) system that prepared an anterior sandwich osteotomy. The cranial segment was moved upward and backward to provide an ideal alveolar relationship, and the geometry of the intermediate space was used to design a titanium implant. Furthermore, a surgical template was derived for the osteotomies, and insertion of dental implants was planned to stabilize both the transposed bone and the intermediate implant on the bony base. An identical implant for augmentation was also fabricated from poly-D,L-lactide in a mold as a possible resorbable carrier for osteoinductive proteins. RESULTS The experimental surgery was successfully performed with maximum precision on the dried mandible. The fabrication of an implant made out of poly-D,L-lactide for the same purpose was also possible. CONCLUSIONS This preliminary experiment showed that it is possible to use CAD/computer-aided manufacturing (CAM) technology to prepare a prefabricated template and a corresponding titanium implant for mandibular augmentation with a high degree of exactness. Dental implants could be planned and integrated in this procedure as well. The fabrication of a mold using this method also provided the opportunity to give a complex shape to possible carriers of osteoinductive substances.