The Effectiveness of Three-Dimensional Osteosynthesis Plates versus Conventional Plates for the Treatment of Skeletal Fractures: A Systematic Review and Meta-Analysis.

PURPOSE: To assess the difference between preformed anatomically shaped osteosynthesis plates and patient-specific implants versus conventional flat plates for the treatment of skeletal fractures in terms of anatomical reduction, operation time, approach, patient outcomes, and complications. MATERIAL AND METHODS: MEDLINE (1950 to February 2023), EMBASE (1966 to February 2023), and the Cochrane Central Register of Controlled Trials (inception to February 2023) databases were searched. Eligible studies were randomised clinical trials, prospective controlled clinical trials, and prospective and retrospective cohort studies (n ≥ 10). Inclusion criteria were studies reporting the outcomes of preformed anatomically shaped osteosynthesis plates and patient-specific implants versus conventional flat plates after treating skeletal fractures. Outcome measures included anatomical reduction, stability, operation time, hospitalisation days, patients' outcomes, and complications. Two independent reviewers assessed the abstracts and analysed the complete texts and methodologies of the included studies. RESULTS: In total, 21 out of the 5181 primarily selected articles matched the inclusion criteria. A meta-analysis revealed a significant difference in operation time in favour of the preformed anatomical plates and patient-specific implants versus conventional plates. Significant differences in operation time were found for the orbital (95% CI: -50.70-7.49, p = 0.008), upper limb (95% CI: -17.91-6.13, p < 0.0001), and lower limb extremity groups (95% CI: -20.40-15.11, p < 0.00001). The mean difference in the rate of anatomical reduction in the lower limb extremity group (95% CI: 1.04-7.62, p = 0.04) was also in favour of using preformed anatomical plates and patient-specific implants versus conventional plates. CONCLUSIONS: This systematic review showed a significant mean difference in surgery time favouring the use of preformed anatomical plates and patient-specific implants for orbital, upper, and lower limb extremity fractures. Additionally, preformed anatomical plates and patient-specific implants in the lower limb group result in a significantly higher rate of anatomical reduction versus conventional flat plates.

Personalized Medicine Workflow in Post-Traumatic Orbital Reconstruction.

Restoration of the orbit is the first and most predictable step in the surgical treatment of orbital fractures. Orbital reconstruction is keyhole surgery performed in a confined space. A technology-supported workflow called computer-assisted surgery (CAS) has become the standard for complex orbital traumatology in many hospitals. CAS technology has catalyzed the incorporation of personalized medicine in orbital reconstruction. The complete workflow consists of diagnostics, planning, surgery and evaluation. Advanced diagnostics and virtual surgical planning are techniques utilized in the preoperative phase to optimally prepare for surgery and adapt the treatment to the patient. Further personalization of the treatment is possible if reconstruction is performed with a patient-specific implant and several design options are available to tailor the implant to individual needs. Intraoperatively, visual appraisal is used to assess the obtained implant position. Surgical navigation, intraoperative imaging, and specific PSI design options are able to enhance feedback in the CAS workflow. Evaluation of the surgical result can be performed both qualitatively and quantitatively. Throughout the entire workflow, the concepts of CAS and personalized medicine are intertwined. A combination of the techniques may be applied in order to achieve the most optimal clinical outcome. The goal of this article is to provide a complete overview of the workflow for post-traumatic orbital reconstruction, with an in-depth description of the available personalization and CAS options.

Surgical treatment of fractures of the zygomaticomaxillary complex: effect of fixation on repositioning and stability. A systematic review.

Management of zygomaticomaxillary complex (ZMC) fractures can be challenging. Consequently, there is a difference in treatment amongst clinicians. In the literature it remains unclear if the number of fixation points affects the quality of the anatomical reduction, stability through time, and potential complications. Therefore, the objective of this study was to assess the outcome of no fixation, one-point fixation and multiple-point fixation of ZMC fractures. MEDLINE, EMBASE and The Cochrane Central Register of Controlled Trials were searched to identify eligible studies. After screening 925 articles, 17 studies fulfilled the inclusion criteria. Based on this systematic review no clear conclusions can be drawn on how stability, repositioning, and postoperative complications are affected by the number of fixation points. Nevertheless, it can be concluded that the advantage of multiple approaches is direct visualisation, and the downside is potentially approach-related complications. This review suggests that intraoperatively assisted cone-beam computed tomography (CBCT) can help improve the quality of the repositioning and by minimising the number of fixation points, the number of postoperative complications could be further reduced.

Technical Note on Three- and Four-Wall Orbital Reconstructions With Patient-Specific Implants.

ABSTRACT: Orbital reconstruction is one of the most complex procedures in maxillofacial surgery. It becomes even more complex when all references to the original anatomy are lost. The purpose of this article is to provide an overview of techniques for complex three- and four-wall orbital reconstructions. Preoperative virtual surgical planning is essential when considering different reconstruction possibilities. The considerations that may lead to different approaches are described, and the advantages and drawbacks of each technique are evaluated. It is recommended to reconstruct solitary three-wall or four-wall orbital defects with multiple patientspecific implants. Optimizations of this treatment protocol are suggested, and their effects on predictability are demonstrated in a case presentation of a four-wall defect reconstruction with multiple patient-specific implants.

Minimally Invasive Treatment With a Patient Specific Implant in Reconstruction of Isolated Anterior Wall Fracture of the Frontal Sinus.

ABSTRACT: Isolated fractures of the anterior wall of the frontal sinus are most often treated through a coronal approach. Although the coronal approach is a relatively easy procedure, the size of the incision is causing more problems related to patient morbidity and recovery time than smaller approaches. A novel, minimal invasive procedure for reconstruction of the anterior wall fracture of the frontal sinus is presented in this article. An endoscopic assisted approach to camouflage the defect of the anterior wall and restore the contour of the frontal bone with a titanium patient specific implant is described in 2 patients. The aim of this procedure is to evaluate the effect on the operating time, recovery time, length of hospital stay and facial scarring compared to the conventional coronal approach. Postoperative evaluation was performed by superimposing pre and postoperative 3D stereophotographs and computed tomography scans. A distance map demonstrated an accurate reconstruction of the preoperatively planned contour. Postoperative recovery of both patients was quick and uneventful with no complications. The use of endoscopically inserted patient specific implant for contour reconstruction in anterior wall fractures of the frontal sinus seems to offer a predictable and minimal invasive alternative to the conventional approach.

A nonsurgical approach with repeated orthoptic evaluation is justified for most blow-out fractures.

OBJECTIVE: This study presents the results of an updated clinical protocol for orbital blow-out fractures, with a special emphasis on nonsurgical treatment and orthoptic evaluation of functional improvement. METHODS: A two-centre multidisciplinary prospective cohort study was designed to monitor the results of a clinical protocol by assessing ductions, diplopia, globe position, and fracture size. Patients underwent clinical assessment and orthoptic evaluation at first presentation and then at 2 weeks and 3/6/12 months after nonsurgical or surgical treatment. Outcome parameters were field of binocular single vision (BSV), ductions, degree of enophthalmos, a diplopia quality-of-life (QoL) questionnaire, and other sequelae or surgical complications. RESULTS: 46 of the 58 patients who completed the 3, 6 and/or 12-month follow-up received nonsurgical treatment. There was full recovery without diplopia or enophthalmos (>2 mm) in 45 of the 58 patients. The other 13 patients had limited diplopia, mainly in extreme upward gaze (average BSV 90). Five of those 13 patients did not experience impairment of diplopia in daily life. The average QoL score at the end of follow-up was 97. No patients developed late enophthalmos. CONCLUSION: This study showed that a high percentage of patients with orbital floor and/or medial wall fracture recovered spontaneously without lasting diplopia or cosmetically disfiguring enophthalmos. The conservative treatment protocol assessed here underlines the importance of orthoptic evaluation of functional parameters.

The advantages of advanced computer-assisted diagnostics and three-dimensional preoperative planning on implant position in orbital reconstruction.

OBJECTIVE: Advanced three-dimensional (3D) diagnostics and preoperative planning are the first steps in computer-assisted surgery (CAS). They are an integral part of the workflow, and allow the surgeon to adequately assess the fracture and to perform virtual surgery to find the optimal implant position. The goal of this study was to evaluate the accuracy and predictability of 3D diagnostics and preoperative virtual planning without intraoperative navigation in orbital reconstruction. METHODS: In 10 cadaveric heads, 19 complex orbital fractures were created. First, all fractures were reconstructed without preoperative planning (control group) and at a later stage the reconstructions were repeated with the help of preoperative planning. Preformed titanium mesh plates were used for the reconstructions by two experienced oral and maxillofacial surgeons. The preoperative virtual planning was easily accessible for the surgeon during the reconstruction. Computed tomographic scans were obtained before and after creation of the orbital fractures and postoperatively. Using a paired t-test, implant positioning accuracy (translation and rotations) of both groups were evaluated by comparing the planned implant position with the position of the implant on the postoperative scan. RESULTS: Implant position improved significantly (P < 0.05) for translation, yaw and roll in the group with preoperative planning (Table 1). Pitch did not improve significantly (P = 0.78). CONCLUSION: The use of 3D diagnostics and preoperative planning without navigation in complex orbital wall fractures has a positive effect on implant position. This is due to a better assessment of the fracture, the possibility of virtual surgery and because the planning can be used as a virtual guide intraoperatively. The surgeon has more control in positioning the implant in relation to the rim and other bony landmarks.

Should Virtual Mirroring Be Used in the Preoperative Planning of an Orbital Reconstruction?

PURPOSE: Mirroring has been used as a diagnostic tool in orbital wall fractures for many years, but limited research is available proving the assumed symmetry of orbits. The purpose of this study was to evaluate volume and contour differences between orbital cavities in healthy humans. MATERIALS AND METHODS: In this cross-sectional study, the left and right orbital cavities of a consecutive sample of patients' computed tomograms were measured. Inclusion criteria were patients with no sign of orbital or sinus pathology or fracture. Outcome variables were differences in volume and contour. Descriptive statistics and Student paired t test were used for data analysis of orbital volume and distance maps were used for analysis of orbital contour. RESULTS: The sample was composed of 100 patients with a mean age of 57; 50% were men. The total mean orbital volume was 27.53 ± 3.11 mL. Mean difference between cavities was 0.44 ± 0.31 mL or 1.59% (standard deviation [SD], 1.10%). The orbital contour showed high similarity, with an absolute mean left-versus-right difference of 0.82 mm (SD, 0.23 mm). CONCLUSION: The authors hypothesize that the measured differences between right and left orbital volumes and contours are clinically minor. In consequence, the use of mirroring tools as part of preoperative planning in orbital reconstruction is legitimate with the aim of simulating the pre-traumatized anatomy.

Natural variation of the zygomaticomaxillary complex symmetry in normal individuals.

OBJECTIVE: The study aim was to investigate variations in the symmetry of the zygomaticomaxillary complex (ZMC) in normal individuals. METHOD: Computed tomography datasets of 200 individuals without facial fractures were analyzed using a validated three-dimensional analysis technique. The absolute average distance (AD) and 90th percentile distance (NPD) were calculated, representing respectively the overall and maximum symmetry between bilateral ZMCs. RESULTS: The mean AD and NPD of the total study group was 0.9 ± 0.3 mm (95% CI 0.3-2.3) and 1.7 ± 0.5 mm (95% CI 0.5-3.9), respectively. The mean AD and NPD in males were 1.0 ± 0.3 mm (95% CI 0.28-2.34) and 1.9 ± 0.5 mm (95% CI 0.5-3.9) versus 0.8 ± 0.3 mm (95% CI 0.4-1.7) and 1.6 ± 0.5 mm (95% CI 0.8-2.9), respectively, for females. A statistically significant difference between male and female was found for both AD and NPD (p < 0.01). The male population <40 years had a mean AD and NPD of 1.0 ± 0.3 mm and 1.8 ± 0.5 mm, which was not statistically significant when compared with males >40 years. CONCLUSION: The naturally occurring anatomic variation in ZMC symmetry described in this study is proposed as a benchmark for evaluating the amount of preoperative displacement and postoperative reduction of ZMC in trauma cases.

Finding the Ledge: Sagittal Analysis of Bony Landmarks of the Orbit.

PURPOSE: This study determined the average distances and angles between anatomic landmarks within the orbit, with an emphasis on localization of the orbital process of the palatine bone. This information will help the surgeon with treatment planning and surgical procedures. PATIENTS AND METHODS: Four anatomic landmarks were identified retrospectively on computed tomograms of 100 adult Caucasian patients (50 men and 50 women): the top of the infraorbital margin superior to the infraorbital foramen (point A), the top of the orbital process of the palatine bone (point B), the anteriormost bony portion of the superior orbital fissure (point C), and the ventrolateral aspect of the bony entrance of the optic canal (point D). The distances between these points were measured, as were the angle between the medial wall of the orbit and a line connecting points A to D at the level of the optic nerve. RESULTS: The mean distances between the orbital rim (point A) and the orbital process of the palatine bone (point B) were 33.8 mm in men and 32.7 mm in women. Men had markedly larger bony orbits than women; however, women had a larger angle than men for the 2 orbits. CONCLUSION: Obtaining these measurements preoperatively can enable a safer and more predictable surgical approach to the orbit, which can help lower the risk of damaging important neighboring structures. A preformed reconstruction plate can be manufactured or a standard reconstruction plate can be customized according to these measurements; during reconstruction, they also can help adequately localize the posterior ledge, specifically the orbital process of the palatine bone. These 2 aspects could ensure a more precise reconstruction of the orbital floor.

The orbit first! A novel surgical treatment protocol for secondary orbitozygomatic reconstruction.

A novel surgical treatment sequence for secondary orbitozygomatic complex (OZC) reconstruction is described. Orbital reconstruction is performed before OZC repositioning. A surgical plan is made: the affected OZC is virtually osteotomized and aligned with a mirrored model of the unaffected OZC. A patient-specific implant (PSI) is designed for orbital reconstruction. Screw holes from the primary reconstruction are used for fixation. Primary screw hole positions at the repositioned OZC are embedded in the design, to guide OZC repositioning. A second patient-specific design is made for guidance at the zygomaticomaxillary buttress. The workflow was utilized in two patients. The PSI was positioned using navigation feedback. After repositioning of the zygomatic complex, the screw hole positions at the infraorbital rim and zygomaticomaxillary buttress seemed to align perfectly: no screw hole adjustments were necessary. Minor deviations were seen between planned and acquired PSI position; the mean errors between planned and acquired OZC position were 1.5 and 1.2 mm. Orbital reconstruction with a PSI before OZC repositioning ensures true-to-original orbital reconstruction. The use of old screw hole positions enables the PSI to be used as a static guide for OZC repositioning. The combination of static and dynamic guidance increases predictability in secondary OZC reconstruction.

Measuring zygomaticomaxillary complex symmetry three-dimensionally with the use of mirroring and surface based matching techniques.

OBJECTIVE: The study aim was to validate a new method for measuring zygomaticomaxillary complex (ZMC) symmetry, which can be helpful in analyzing ZMC fractures. METHODS: Three-dimensional virtual hard-tissue models were reconstructed from computed tomography (CT) datasets of 26 healthy individuals. Models were mirrored and superimposed. Absolute average distance (AD) and 90th percentile distance (NPD) were used to measure overall and maximal symmetry. The Intraclass Correlation Coefficient (ICC) was calculated to measure interobserver consistency. In order to determine whether this technique is applicable in ZMC fracture cases, 10 CT datasets of individuals with a unilateral ZMC fracture were analyzed. RESULTS: For the unaffected group the mean AD was 0.84 ± 0.29 mm (95% CI 0.72-0.96) and the mean NPD was 1.58 ± 0.43 mm (95% CI 1.41-1.76). The ICC was 0.97 (0.94-0.98 as 95% CI), indicating almost perfect interobserver agreement. In the affected group the mean AD was 2.97 ± 1.76 mm (95% CI 1.71-4.23) and the mean NPD was 6.12 ± 3.42 mm (95% CI 3.67-8.57). The affected group showed near-perfect interobserver agreement with an ICC of 0.996 (0.983-0.999 as 95% CI). CONCLUSIONS: The method presented is an accurate instrument for evaluation of ZMC symmetry, which can be helpful for advanced diagnostics and treatment evaluation.

How reliable is the visual appraisal of a surgeon for diagnosing orbital fractures?

PURPOSE: The aim of this study was to evaluate the usefulness of intra-operative visualisation, endoscopic assistance, and CT measurements for estimating the orbital fracture size and complexity. METHODS: Ten human cadaver heads were subjected to thin-slice computed tomography (CT). Standardised fractures were created using piezoelectric surgery in accordance with the Jaquiéry classification system. Four surgeons and one anatomist used six different observation methods to visualise and describe the orbital defects. RESULTS: The intraclass correlation coefficients (ICCs) for the fracture length measurements were relatively low for all observation methods (range, 0.666-0.883). CT measurements of width showed high consistency (ICC, 0.910). The surface area of the defect was highly overestimated by all methods (range, 121-184%). None of the observers was able to accurately estimate the length or width of 95% of the defects within an error range of ±0.75 cm. CONCLUSION: CT measurements are the most consistent and accurate tool for estimating the critical size of orbital factures. In daily practice, a measurement tool in a DICOM viewer could be used, although software packages that allow manual adjustments are advisable. Direct intraoperative visualisation and surgeon experience are of limited value in the estimation of fracture size and complexity, and endoscopy provides no additional advantages.

Quantitative Assessment of Orbital Implant Position--A Proof of Concept.

INTRODUCTION: In orbital reconstruction, the optimal location of a predefined implant can be planned preoperatively. Surgical results can be assessed intraoperatively or postoperatively. A novel method for quantifying orbital implant position is introduced. The method measures predictability of implant placement: transformation parameters between planned and resulting implant position are quantified. METHODS: The method was tested on 3 human specimen heads. Computed Tomography scans were acquired at baseline with intact orbits (t0), after creation of the defect (t1) and postoperatively after reconstruction of the defect using a preformed implant (t2). Prior to reconstruction, the optimal implant position was planned on the t0 and t1 scans. Postoperatively, the planned and realized implant position were compared. The t0 and t2 scans were fused using iPlan software and the resulting implant was segmented in the fused t2 scan. An implant reference frame was created (Orbital Implant Positioning Frame); the planned implant was transformed to the reference position using an Iterative Closest Point approach. The segmentation of the resulting implant was also registered on the reference position, yielding rotational (pitch, yaw, roll) as well as translational parameters of implant position. RESULTS: Measurement with the Orbital Implant Positioning Frame proved feasible on all three specimen. The positional outcome provided more thorough and accurate insight in resulting implant position than could be gathered from distance measurements alone. Observer-related errors were abolished from the process, since the method is largely automatic. CONCLUSION: A novel method of quantifying surgical outcome in orbital reconstructive surgery was presented. The presented Orbital Implant Positioning Frame assessed all parameters involved in implant displacement. The method proved to be viable on three human specimen heads. Clinically, the method could provide direct feedback intraoperatively and could improve postoperative evaluation of orbital reconstructive surgery.

Orbital volume analysis: validation of a semi-automatic software segmentation method.

PURPOSE: The purpose of this study was to validate a quick, accurate and reproducible (semi-) automatic software segmentation method to measure orbital volume in the unaffected bony orbit. Precise volume measurement of the orbital cavity is a useful addition to pre-operative planning and intraoperative navigation in orbital reconstruction. METHODS: In 21 CT scans, one unaffected orbit was selected to compare manual segmentation (gold standard) with three segmentation methods using iPlan software (version 3.0.5; Brainlab, Feldkirchen, Germany): automatic (method A), automatic minus bone/air masks (method SA) and automatic minus masks followed by manual adjustments (method SAA). First, validation of the manual segmentation and a newly described method for the anterior boundary was performed. Subsequently the accuracy, reproducibility and time efficiency of the methods were examined. Measurements were performed by two observers. RESULTS: The intraclass correlation for the interobserver agreement of the anterior boundary was 0.992, and the intraobserver and interobserver agreement for the manual segmentation were 0.997 and 0.994, respectively. Method A had an average volumetric difference of 0.49 cc (SD 0.74) in comparison with the gold standard; this was 0.24 cc (SD 0.27) for method SA and 0.86 cc (SD 0.27) for method SAA. The average time for each method was 38 (SD 5.4), 146 (SD 16.0) and 327 (SD 36.2) seconds per orbit. CONCLUSION: The built-in automatic method A is quick, but suboptimal for clinical use. The newly developed method SA appears to be accurate, reproducible, quick and easy to use. Manual adjustments in method SAA are more time-consuming and do not improve volume accuracy. The largest volume discrepancy is located near the inferior orbital fissure.

Predictability in orbital reconstruction: A human cadaver study. Part I: Endoscopic-assisted orbital reconstruction.

In the treatment of orbital defects, surgeon errors may lead to incorrect positioning of orbital implants and, consequently, poor clinical outcomes. Endoscopy can provide additional visualization of the orbit through the transantral approach. We aimed to evaluate whether endoscopic guidance during orbital reconstruction facilitates optimal implant placement and can serve as a convenient alternative for navigation and intra-operative imaging. Ten human cadaveric heads were subjected to thin-slice computed tomography (CT). Complex orbital fractures (Class III/IV) were created in all eligible orbits (n = 19), which were then reconstructed using the conventional transconjunctival approach with or without endoscopic guidance. The ideal implant location was digitally determined using pre-operative CT images, and the accuracy of implant placement was evaluated by comparing the planned implant location with the postoperative location. There were no statistically significant differences (p > 0.05) in the degree of implant dislocation (translation and rotation) between the transconjunctival orbital reconstruction and the endoscopic-assisted orbital reconstruction groups. Endoscopic-assisted orbital reconstruction may facilitate the visualization of orbital defects and is particularly useful for training purposes; however, it offers no additional benefits in terms of accurate implant positioning during the anatomical reconstruction of complex orbital defects.