University of Groningen

Three dimensional virtual surgical planning for patient specific osteosynthesis and devices inoral and maxillofacial surgery. A new era.Kraeima, Joep

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C H A P T E R 1

G E N E R A L I N T R O D U C T I O N

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General introduction

GENERAL INTRODUCTION

Plan your operationThree dimensional (3D) virtual surgical planning (VSP) has become a structural component of multiple care paths in oral and maxillofacial surgery (OMFS). These include head and neck oncology, orthognathic-, temporomandibular joint-, craniofacial trauma surgery and implantology (1-4).

A 3D VSP is based on radiologic imaging data that are, in most cases, already part of the routine pre-operative/diagnostic work-up. The 3D VSP imaging workhorse for OMFS is a computed tomography (CT) or Cone Beam CT (CBCT) dataset. It can also be a Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) dataset, or a combination of these modalities, as demonstrated in this thesis. Dedicated 3D VSP software gives a detailed 3D virtual model of the patient from these datasets in order to measure, evaluate, simulate or correct parameters that are relevant for the treatment.

This 3D VSP concept has evolved from a supporting virtual measurement and evaluation tool to an integrated method that allows complete preoperative surgical decision making and a patient specific implant design for surgical procedures. Furthermore, it allows preoperative evaluation of multiple treatment scenarios and accurate comparison with other cases or experiences, all in a complete virtual setting (4-10).

The 3D VSP is translated from the virtual environment to the actual surgical procedure by using 3D printed patient specific guides and templates or real-time surgical navigation techniques (4). This thesis will focus on applications that can be translated by 3D printed surgical guides. These guides are unique for each patient and are fitted, after sterilisation, onto the patient during surgery. They can support the surgeon’s armamentarium in order to perform an osteotomy, for example, according to the virtual planning. In addition, this concept can enable exact placement of custom implants or osteosynthesis materials. The use of 3D VSP and guided surgery, combined with custom implants, has led to improved accuracy, outcome predictability and was reported to be time saving (6, 11-15). In Figure 1 a schematic overview of a 3D VSP workflow, for a head and neck oncology case, is presented as an example. The steps that are part of this workflow are representative for other applications in OMFS described in this thesis as well.

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Chapter 1

Figure 1: An example of a 3D VSP workflow. The example presents a head and neck oncology case.

This new era of 3D VSP requires the following components to be optimised:

1. Integration of multi-modality imaging into a single 3D VSP.2. Systematic comparison with conventional methods, including thorough testing

and validation of new 3D VSP applications.3. Definition of adequate indications for the use of 3D VSP. 4. Definition of required technical and medical expertise which can conform to the

correct implementation of 3D VSP.

This thesis addresses these components and aims to present new and validated methods in three main OMFS pillars.

The Technical Physician – A high tech health professional

Adequate implementation of 3D VSP in the clinical routine requires easy access to a 3D software environment, in which the 3D VSP is set-up and adjusted. Moreover, both the acquisition and processing of the radiologic image data should be optimized for 3D VSP (16, 17). Such optimisation and processing in the 3D VSP software requires expertise in imaging, software, surgical procedures and anatomy as well as pathology. It also requires expertise in the fusion of imaging data, delineation of pathology, segmentation of anatomical structures, surgical approaches, virtual resection and reconstruction and finally in the design and fabrication of patient specific medical devices. Basically, substantial technical expertise, combined with radiological and surgical expertise, is required in order to develop, validate and implement 3D VSP applications.

A new health professional, the Technical Physician (TP), was introduced in the Netherlands in 2003. The TP is trained in a combination of the above mentioned fields of expertise. The TP is trained to independently perform reserved clinical actions, equivalent to a physician, as well as to understand the technology from an engineer’s

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General introduction

perspective. Under Dutch law, the TP is allowed to perform specific clinical actions, as the profession is registered in the Wet Beroepen Individuele Gezondheidszorg, (BIG), Article 36a Wet BIG (18, 19).

The TP can be seen as a recent addition to the already multi-disciplinary team of professionals that diagnose, treat and take care of patients in the field of OMFS through innovations and by accelerating the use of the latest technological applications, as will be described in this thesis, on the 3 main OMFS pillars. This thesis aims to optimize the workflow for- and clinical integration of 3D VSP and, when applicable, patient specific osteosynthesis within OMFS.

Operate your planThe adage ‘plan your operation and operate your plan’ applies to every surgical procedure (20), not just to the application of 3D VSP. Three dimensional VSP is, however, the current instrument to ‘plan your operation’ with multiple applications within OMFS. Therefore, this thesis will provide an overview on how the (3D) planning of surgery can be optimised using multi-modality data fusion, a combination of 3D software pathways and 3D printing and milling techniques for patient specific medical devices. These applications have been developed and systematically validated by a multi-disciplinary team that was supplemented with the expertise of a new health care professional: the technical physician.

The sections below give a detailed introduction to the developments and potential 3D strategies within this thesis, per sub discipline.

Surgery in head and neck oncology – What about the margins?

Surgical removal of squamous cell carcinomas in the oral cavity close to or within mandibular bone, often necessitates resecting part of the mandible with a microscopic free margin of at least 5mm on both sides of the resection, according to current clinical guidelines (21). The oncologic-surgical challenge is to plan and perform an adequate resection with sufficient margin, based on the pre-operative information. Nowadays, mandibular malignancy resections frequently include the use of 3D VSP and guided surgery techniques based on CT data. Both intra-operative navigation and 3D printed surgical guides have been proven to provide precise translation of the 3D VSP to the surgical procedure (5, 13, 22, 23). Despite accurate translation of the VSP, it is not always clear where to virtually plan the resection margins on the mandible in the first place, which necessitates intraoperative exploration. This can lead to uncertainty in surgical outcome. The planning for adequate tumour removal should include detailed bone

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Chapter 1

information as well as tumour characteristics such as localisation, size, shape and extension (24). It is best to extract this information from multi-modality imaging: CT and MRI together (25). Until recently, most 3D VSP applications were based on CT data only (13, 23).

It is reported that a fusion of CT and MRI 2D slices combines the sensitivities of both modalities. This provides the surgeon with more accurate information regarding the tumour in relation to the surrounding structures (24, 26-29). The combination of information with regard to localisation, extent, size and shape, as provided by CTs and MRIs is crucial for adequate resection planning (24, 29). A fusion of these modalities is already being performed routinely within e.g., the field of radiation oncology(30), as well as for several applications in the field of orbital, pelvic and skull base region tumour surgery (24, 31, 32).

This thesis aims to develop and validate, through cadaveric testing and clinical integration, a modular workflow that enables CT and MRI data fusion to optimise safe, 3D VSP oncologic resections of the maxilla or mandible. The accuracy of planned- versus performed resections, and the number of non-tumour free bone resections, in comparison with a historic cohort, are the outcome measures that objectify the added value of such a workflow.

‘MRI only’ 3D VSPAccording to the workflow described above, MRI is the main 3D VSP tumour identifier for oncologic resection planning (24, 29), whereas CT is the modality that provides just the 3D bone model. This multi-modality workflow necessitates fusion of both the MRI and CT data, potentially introducing an accuracy error of >1mm (17, 33, 34).

A next step towards optimising the 3D VSP workflow would therefore be a 3D VSP planning based on a single modality, still providing a 3D model of both the tumour and the bone. Here, MRI is the most promising for a single-image-modality VSP workflow, since both tumour and bone information can be retrieved from MRI data (16, 35, 36). The aim of this thesis is to explore the options for MRI mandibular bone modelling as an alternative for the CT-MRI-based workflow for mandibular resections and reconstructive surgery planning in oral cancer surgery.

Three dimensional VSP applied to surgical management of osteoradionecrosisThe previously described workflow enables the fusion of multi-modality imaging (CT, MRI and PET). Besides oncologic resections, it can have other applications as well. Osteoradionecrosis (ORN) is defined as bone death following radiotherapy (RT),

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General introduction

characterized by a non-healing area of exposed bone (37, 38). When a patient develops severe, or class III, ORN (39, 40) a surgical intervention may be indicated, including the removal of the affected bone. Currently, however, these procedures do not use the 3D VSP concept, as no consensus has been reached as to where and how to plan the resection margins.

There is a pathophysiological relationship between the occurrence of ORN in the jaw and the radiation dose i.e., the radiation dose is reported to be a risk factor for the development of ORN. The risk of developing ORN with a dose of 40-60Gy is considered to be medium whereas 60Gy is frequently reported as high (41-44).

Including the original radiation dose as a visual volume into the 3D VSP can support the decision with regard to resection planning. This thesis introduces a method for 3D VSP based on the 3D information from the received, causative, radiation dose; the received dose can be visualized for each location of the affected bone. Moreover, this visualization technique can be applied to plan the drilling of screw holes for osteosynthesis plate fixation, in the case of necessary secondary reconstruction, outside the high dose field.

Orthognathic Surgery – Maxillary patient specific osteosynthesis

Similar to head and neck oncologic surgery, 3D VSP has contributed to the evolution of these procedures in orthognathic surgery, improving the diagnostics, accuracy and predictability of the outcome and allowing for pre-operative simulation of surgical options (45, 46). In comparison to the conventional 2D cephalometry and plaster based surgical planning, 3D VSP enables improved anatomical landmark identification through a combination of multi-modality imaging (e.g., CBCT and 3D stereo photogrammetry) and improved simulation of soft tissue effects (4, 45, 46). Good clinical outcome of the actual surgical procedure depends on adequate translation of the 3D VSP to the patient. In orthognathic surgery, the maxilla is usually guided and positioned during a Le Fort I osteotomy by a splint (47, 48), supported by intra- and/or extra oral reference points (48). The use of 3D VSP has led to the introduction of 3D printed or milled splints. They are translation instruments which are reported to be more accurate and reliable in comparison to conventional splints fabricated manually on plaster models of the dentition. However, they do not change the translation concept of the planning towards the surgical procedure (48-51). Despite an increase in accuracy of the splints when using 3D VSP, the translation of the planning to the surgical procedure remains subject to variations, due to errors in seating the splint, vertical positioning and intraoperative condylar sag (51). In addition, mandibular or condylar positioning during surgery causes most of the deviation in positioning the maxilla, and not the splint itself (52, 53). Several splintless procedures have been developed to overcome the translation errors

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Chapter 1

introduced by a splint that is related to the mandibular position, in order to translate the maxilla to the planned position, using patient specific osteosynthesis (PSO) (8, 12, 14, 49, 54-57). These reports, however, only include case reports and small series, which lack a systematic comparison with the conventional splint based workflows. The use of PSO for maxillary fixation requires a surgical guide or template that indicates the correct position of the screw holes and planned osteotomy. The value of PSO applications in head and neck oncology have already enabled accurate fixation of two bone segments based on the 3D VSP (5, 58, 59). This same technique should ensure, in the case of orthognathic surgery, exact translation of the maxilla to the planned position.

This thesis aims to develop, validate and objectify the value of a workflow for 3D VSP and PSO in orthognathic Le Fort I surgery. The primary outcome measure is the deviation in millimetres of the planned vs. the realised maxillary position.

Temporomandibular joint surgery – The Groningen principle custom TMJ total joint replacement

The third part of this thesis describes the development and validation of a custom 3D VSP based total temporomandibular joint- total joint replacement (TMJ-TJR) device based on the previously mechanically and materially in vitro and in vivo tested techniques and applied as a stock variant (60, 61). The aim of the device is to improve TMJ functionality and reduce pain, according to a previously reported concept of the Groningen TMJ-TJR device with a lowered centre of rotation (62, 63).

Patients suffering from osteoarthritis, ankylosis, post-traumatic ankylosis or tumours in the TMJ area can present with symptoms such as severely restricted mouth opening, pain or other dynamic restrictions of the mandible. A TMJ-TJR device may be indicated when conservative treatment or regular open joint surgery (gap-osteotomy with arthroplasty) do not suffice (64). Previous studies have reported that placement of TMJ-TJR devices can also improve maximum mouth opening and reduce pain (64, 65) but, a stock TMJ-TJR device can fit sub-optimally; requiring per-operative bone re-contouring of the fossa area in particular, or it can result in post-operative malocclusion due to inadequate condylar length (65, 66). Moreover, the TMJ-TJR devices require osseo-integration in order to remain functional in the long-term. This can only be achieved as long as the fossa and mandibular parts are in proper and primary stable contact with the host bone (67, 68). Application of 3D VSP, followed by customisation of the TMJ prosthesis and adaptation of the bone connective surfaces to the anatomy of the individual patient, could overcome these problems.

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General introduction

The aim of this thesis is to optimise and customize the design of the Groningen TMJ-TJR device, through the implementation of patient-specific 3D VSP and the use of 3D printing. The accurate translation from 3D VSP to the actual placement will be validated in a human cadaver series. It is hypothesized that the customized TMJ-TJR device and the introduction of custom placement guides provides an accurate translation of the 3D VSP towards the cadaver.

GENERAL AIM OF THE THESIS

The general aim of the research presented in this thesis is to develop and validate optimized 3D VSP workflows for three main Oral and Maxillofacial Surgery pillars.

These pillars are: head and neck oncologic surgery, orthognathic surgery and temporomandibular joint surgery.

The specific aims are:

• Development and validation of a CT and MRI data fusion workflow, for 3D modelling of both bone and tumours (chapter 2).

• Clinical integration of the multi-modality workflow in order to evaluate and improve tumour free bone resection of the mandible (chapter 3).

• Exploration of potential improvements in the accuracy of the 3D VSP workflow with the introduction of ‘MRI-only’ planning (chapter 4).

• Introduction of 3D VSP into secondary surgical treatment of ORN resulting in adequate resection and screw position planning (chapter 5).

• Development and validation of an accurate transfer protocol of the 3D VSP, for maxillary translation, in orthognathic surgery, by means of PSOs (chapter 6).

• Objectifying the added value and specifying indications for the use of PSOs in maxillary orthognathic surgery by means of a multi-centre RCT (chapter 7).

• Optimizing a combination of 3D VSP and CAD/CAM customizations in order to improve the Groningen TMJ prosthesis in terms of placement accuracy (chapter 8).

• Integrating the expertise of a new high-tech health professional, the technical physician, into the clinical routine of head- and neck oncologic surgery, orthognathic surgery and TMJ surgery (chapters 3, 7 and 8).

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General introduction

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