VIRTUAL SURGICAL PLANNING AND TRUMATCH CMF SOLUTIONS

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1 VIRTUAL SURGICAL PLANNING AND TRUMATCH CMF SOLUTIONS VALUE ANALYSIS BRIEF VALUE SUMMARY Accuracy Virtual surgical planning produces results that are accurate, consistent, and reproducible. Efficiency The use of virtual surgical planning can offer greater efficiencies compared to conventional pre-operative planning methods for patients, surgeons, and hospitals. Patient Benefit Virtual surgical planning can offer patients benefits in terms of better outcomes, aesthetics, and patient satisfaction. INTRODUCTION This value brief presents information on the potential clinical, patient, and economic benefits of using virtual surgical planning, including the use of TRUMATCH CMF Solutions, to plan the surgical procedure, osteotomies, and patient specific implants used in craniomaxillofacial (CMF) reconstruction. Virtual surgical planning technology offers surgeons a method for performing mandible reconstruction, orthognathic procedures, midface reconstruction, cranial reconstruction, and distraction procedures with the potential for greater accuracy, efficiency, and patient benefit compared to traditional planning methods. The referenced data were obtained through a MEDLINE search for clinical and economic studies published in the last 10 years and resulted in a total of 63 papers. Papers were selected for use in this value brief based on publication date (majority published between ) and rigor of clinical data. Publications referenced in this value brief using TRUMATCH CMF Solutions include the use of the trade name. BACKGROUND Pre-operative planning methods have remained largely unchanged over the last 50 years. Current methods are more of an art than a science. 16 Craniomaxillofacial surgery involves the correction of congenital and acquired deformities of the skull and face. In the United States, an estimated 17 million people aged 12 to 50 years will require CMF corrective surgery for congenital and developmental deformities. 16,17 Approximately 28,000 new patients per year will require surgery to correct defects after tumor ablation, 200,000 patients will undergo surgery for post-traumatic defects, and 6,000 patients will have need of prosthetic and autogenous reconstruction of the temporomandibular joint (TMJ). 16 These procedures are primarily performed by plastic surgeons (facial plastics and reconstructive surgery, 43% of procedures) and oral and maxillofacial surgeons (28% of surgeons). 2 A recent survey shows the most commonly performed procedures are midface and orbital reconstruction, mandibular reconstructions with free bone graft, and orthognathic surgery and distraction with 40%, 37%, 22%, and 18% of surgeons performing at least 1 5 of these procedures per year, respectively (see Figure 1). 2 18% 22% 40% 37% Midface and Orbital Reconstruction Mandibular Reconstructions with free bone graft Orthognathic Surgery Distraction Figure 1: Percentage of surgeon respondents performing at least 1 5 procedures per year 2 The success of surgical procedures to correct CMF deformities depends not only on the operative technique, but also on the development of the surgical plan. 16 The last 50 years have seen advances and improvements in the technical aspects of the surgery (e.g. rigid fixation, minimally invasive procedures, etc). However, the pre-operative planning methods have remained largely unchanged. 16 Conventional pre-operative planning methods were developed at a time before the advent of 3-dimensional imaging. As a result, communication of reconstructive techniques was descriptive in nature, and surgical outcomes were variable. 9 Conventional Pre- operative Surgical Planning Orthognathic Procedures For orthognathic procedures, conventional pre-operative surgical planning includes a cephalometric analysis to diagnose the patient s condition based on the relationships Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief DePuy Synthes Companies 1

2 between bony and soft tissue landmarks in the face. 5,16 A preliminary pre-operative surgical plan is developed based on the patient s diagnosis, and frequently alternative plans are developed as well. 16 The surgical plan(s) are simulated using prediction tracings based on two-dimensional cephalometric radiographs and dental model surgery where a model is physically cut and moved to the desired position. 16,15 In some cases, surgeons obtain CT-based prototyping models (e.g. stereolithography) to simulate skeletal surgery. After the surgical simulation is complete, the surgeon finalizes the surgical plan. The final step is to transfer the surgical plan to the patient at the time of surgery. For orthognathic procedures, the surgical plan is transferred to the patient using surgical splints and selected measurements. 16 The splints are shaped based on the same dental model on which the surgery was simulated. Mandible Reconstruction Procedures Reconstruction of the mandible using bone graft is a challenging surgical procedure undertaken to correct tumor resection, traumatic injury, or congenital deformities of the lower jaw. 10 Bone graft is typically harvested from the fibula, iliac crest, or scapula. The fibular bone graft has become the workhorse and preferred method for mandibular reconstruction due to the adequate bone stock length and acceptance of dental implants. 10 The use of fibular bone grafts provides surgeons with a more predictable mandibular reconstruction technique; however, there remains a need for improved precision and accuracy of the reconstruction. 10 Conventional pre-operative planning for mandible reconstruction procedures consists of an evaluation of the anticipated mandibular defect. 4 This is commonly done with a panoramic radiograph and computed-tomography (CT) scan of the mandible. In oncologic cases, a detailed discussion with the ablative surgeon is important so that the reconstructive surgeon can plan the anticipated defect size and tissues to be replaced. 4 A clinical assessment is also conducted of the lower extremity and foot to ensure the suitability of the fibula. 4 Intra-operatively, the fibular bone grafts used in mandible reconstruction procedures must be harvested and shaped using a surgeon s best judgment. After harvesting the fibula, a flexible plastic ruler is sometimes used to measure and plan the bone graft. 4 This typically results in a larger resection of fibular bone than what is needed for the bone graft. 7 Although measurements made during the planning process may be used to guide the surgery, the majority of the time the shaping of the graft is more of an art than a science. 16 Challenges with Conventional Pre-operative Surgical Planning Methods Conventional pre-operative surgical planning methods may result in reduced accuracy between planned measurements and actual surgical outcomes. Xia et al., reported several challenges with conventional pre-operative surgical planning techniques. 16 Measurements made as part of the pre-operative planning procedure are routinely made using various data sources (e.g. cephalometric radiographs, cone-beam CT scans) that utilize different patient orientations. 5,16 If the differences in these measurements are not accounted for, discrepancies may occur. 5,16 For orthognathic procedures, these discrepancies may result in up to a 15% difference between the planned maxillary projection and actual outcomes. 16 The surgical plan developed using conventional pre-operative planning methods is a mental picture that a surgeon must effectively communicate to the surgical team. This may be difficult and result in surgical inaccuracies. 16 Another challenge of conventional pre-operative surgical planning includes the lack of a tangible 3-dimensional model leaving a surgeon to create this picture in their minds. 16 Communicating this mental picture to the treatment team may prove difficult and result in inaccuracies. 16 Some surgeons may choose to use CT-based stereolithography methods to preplan more complex craniomaxillofacial reconstruction cases. 14 These prototypes result in an increased cost to the hospital and only allow one iteration of the pre-surgical plan. Additionally, the use of conventional pre-operative planning does not provide surgeons any method for transferring the surgical plan to the patient for procedures that do not involve dentition. 16 Conventional pre-operative planning techniques may reduce operating room efficiencies due to increased time needed for intra-operative shaping of bone grafts and splints. 2 DePuy Synthes Companies Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief

3 Conventional pre-operative planning methods may also reduce operating room efficiencies largely due to the shaping of the graft and splints used in mandibular reconstruction and orthognathic procedures, respectively. These bone grafts are typically shaped under ischemia on the back table of the operating room for mandible reconstruction procedures. The more complex the case, the longer the time needed for shaping the graft. 14 Increases in ischemia time may negatively influence the graft survival. 11,15 Virtual Surgical Planning Virtual surgical planning represents a real paradigm shift overcoming the main limitations of the conventional [pre-operative] planning technique. 19 Virtual surgical planning technology allows surgeons to perform virtual surgery and create a 3-dimensional prediction of patients surgical outcomes as if they are performing surgery in the operating room. 16 The outcome of this virtual surgical planning is an operative plan case report that communicates the detailed surgical plan to all individuals in the surgical suite and to the patient in a way that is designed to be accurate and reproducible; therefore, resulting in better surgical outcomes and improved economic efficiencies when compared to conventional pre-operative surgical planning methods. 7,14,17,18 For mandible reconstruction procedures, fibular grafts are harvested using customized cutting guides to minimize the amount of excised bone TRUMATCH CMF Solutions Virtual Surgical Planning TRUMATCH CMF Solutions virtual surgical planning allows the surgeon to make operative decisions, visualize the patient anatomy, and develop a surgical plan before entering the operating room. The pre-operative virtual planning session is facilitated by a clinical engineer and guided by the surgeon. During this session, surgeons can visualize the defect area and simulate skeletal osteotomy harvest and reconstruction sites (Figure 2). The decisions made during the planning session are documented in a written case report to aid in transferring the surgical plan to the operating room staff and patient. 1 Virtual surgical planning is also useful in replicating challenging trauma cases requiring reconstruction. 14,15 In these cases, the extent of surgical simulation using conventional pre-operative surgical planning is limited, and most of these procedures are not pre-operatively planned using surgical simulation in clinical practice. 16 TRUMATCH CMF SOLUTIONS Features and benefits of the TRUMATCH CMF Solutions technology include the following: The PROPLAN CMF Software enables interactive, web-based planning sessions that allow the surgeon to visualize and plan the procedure prior to making an incision Intra-operative surgical guides that translate the pre-operative plan directly to the treatment staff and patient Three-dimensional anatomic bone models derived from a patient s CT scans aid in surgical planning and allow surgeons to effectively communicate the plan to the treatment staff Figure 2. Virtual surgical planning software 1 Surgical Guides and Splints After the case is planned and approved, patient specific surgical guides and splints are designed and produced for use during surgery (Figure 3). 1 Patient specific surgical guides and splints assist with accurate harvest and shaping of the bone graft segments, their position relative to the implants, and final positioning of the implants. Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief DePuy Synthes Companies 3

4 Figure 3. Surgical guides and splints 1 Anatomic Bone Models Anatomic bone models derived from a patient s CT scans are a tactile representation of the patient anatomy or planned surgical outcome (Figure 4). 1 Anatomic bone models allow surgeons to accurately and effectively communicate the surgical plan to the patient and surgical treatment team. repositioning was performed using chin templates generated by virtual surgical planning technology. The accuracy of the virtual surgical planning protocol was assessed by comparing the planned outcomes with the actual post-operative outcomes. These outcomes were compared between patient cohorts where chin templates were used and not used, and the differences between groups were statistically significant (p < 0.05). The results of this study show positional and orientational vectors were more accurate with virtual surgical planning (see Table 1). Chin (with template designed with virtual surgical planning Position Difference Orientation Difference p Min Max Min Max value 0.6 mm 1.0 mm <0.05 Chin (without template) 1.7 mm 3.5 mm Table 1. Differences between outcomes planned with virtual surgical planning and actual post-operative outcomes 7 Another important result from this study is the reproducibility of the results. Different surgeons with varying degrees of familiarity with virtual surgical planning and working in 3 distinct geographic regions, all generated similar results. 7 Figure 4. Anatomic bone model 1 CLINICAL VALUE Accuracy: Virtual surgical planning produces results that are accurate, consistent, and reproducible. Orthognathic Procedures A recent multicenter, prospective clinical study published by Hsu et al. reported increased accuracy with the use of virtual surgical planning for orthognathic procedures. 7 In this study, 65 patients were enrolled at 3 centers by surgeons with varying degrees of familiarity with pre-planning software. All patients underwent orthognathic surgery using surgical splints and patients with asymmetry underwent chin repositioning. At one center, the chin Mandible Reconstruction Accuracy of virtual surgical planning was also studied by Modabber et al. in a prospective, randomized controlled clinical study. 12 In this study, an equal number of patients underwent mandible reconstruction with virtual surgical planning and without. When using virtual surgical planning and the patient-specific fibular cutting guide, there were no deviations between the size of the fibular defect and the size of the bone graft in the reconstruction site (Table 2). Without the use of the cutting guide, a mean size difference of 1.92 cm was reported. The difference between groups was statistically significant. Virtual Surgical Planning Conventional Surgery Mean Difference 0 mm 1.92 cm p value Table 2. Mean differences between the size of the bone graft and the defect region 12 4 DePuy Synthes Companies Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief

5 A recent bench top study by Logan et al. also examined the accuracy in surgical outcome between mandible reconstruction procedures performed with and without virtual surgical planning. 10 Five surgeons participated in this repeated-measures study. In this study, the surgeons were asked to reconstruct a 3-dimensional model of a mandible with a large angle-to-angle defect. In the first working session, the surgeons were asked to conduct the procedure free-hand using conventional intra-operative techniques to prepare the fibular bone grafts. During the second working session, the surgeons were asked to do the same procedure using patient-specific cutting guides designed using virtual surgical planning techniques. Overall results showed the use of virtual surgical planning improved the accuracy and consistency of the procedure compared to conventional techniques. The measurement of the height of the fibular graft ranged by mm in the free-hand session and ranged by 4.87 mm in the session using virtual surgical planning. Additionally, the free-hand session resulted in a larger median as well as a larger range for these measurements compared to the session utilizing virtual surgical planning, thereby showing that the surgeons were more consistent in the session with virtual surgical planning. Efficiency: The use of virtual surgical planning may result in a reduction in pre-operative planning time as well as operating room time compared to conventional pre-operative planning methods. Orthognathic Procedures Xia et al. also examined the efficiency of orthognathic surgery using virtual surgical planning. 17 In this study, the time spent by the surgeon and patient for pre-planning the procedure was evaluated for both virtual surgical planning and conventional pre-operative planning procedures. The results are shown in Figure 5. Hours Surgeon Time Patient Time A study published by Iorio et al. also examines the efficiency of using virtual surgical planning for orthognathic procedures. 8 This study showed that the mean time spent by surgeons using virtual surgical planning was minutes compared to 5 hours using conventional pre-operative planning methods. 8 Mandible Reconstruction In the prospective, randomized controlled clinical study mentioned previously, Modabber et al. studied the intraoperative time of shaping the bone graft and the ischemic time in mandible reconstruction procedures. 12 When virtual surgical planning was utilized, a reduction of 21.2 min was reported compared to conventional methods due to the lack of time needed for shaping the graft. The difference between groups was statistically significant (p < 0.05). A study by Hanasono et al. examined the operating room time of the overall mandible reconstruction procedure using virtual surgical planning methods in a case-controlled study. 6 The mean operative time for patients undergoing mandible reconstruction using one fibular bone graft with virtual surgical planning was 8.8 hours compared to 10.5 hours for the control group. A reduction in operating room time was also reported by Seruya et al. in a recently published multicenter, retrospective review using TRUMATCH CMF Solutions for mandible reconstruction. In this study, the reduction in operating time was 23 minutes between groups in favor of virtual surgical planning largely due to the reduction in time needed for shaping the bone graft. 15 Patient Benefit: The use of virtual surgical planning may result in reduced ischemia time and improved clinical outcomes compared to conventional pre-operative planning methods. A reduction in ischemia time of the fibular bone graft used in mandible reconstruction procedures may positively influence the survival of the bone graft and may translate into improved clinical outcomes for the patient. 15 Specifically, the greater the ischemia time for the bone graft, the greater the risk of microvascular complications. 15 Virtual Surgical Planning Conventional Pre-Operative Planning Figure 5. Differences in mean time (hours) spent pre- operatively planning the surgical procedure by surgeon and patient 16 Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief DePuy Synthes Companies 5

6 Virtual surgical planning was shown by Modabber et al. and Seruya et al. to reduce the ischemia time of the fibular bone graft in patients undergoing mandible reconstruction compared to conventional pre-operative planning methods. Results from these studies are shown in Table 3. Virtual Surgical Planning Conventional Planning Modabber et al. 12 Seruya et al. 15 Ischemia time (min) Ischemia time (min) Difference p value p < 0.05 p < 0.05 Table 3. Mean differences in ischemia time from published sources There is a direct correlation between the health of the bone graft and the ischemic time. 11 The use of virtual surgical planning aids in minimizing the ischemic time between delivery of the bone graft and revascularization at the defect site as well as damage to the graft due to extensive handling during the shaping procedure. 11 In a study published by Modabber et al., the success of the bone graft was 100% when virtual surgical planning was used compared to 86.7% for conventional treatment. 11 Patient satisfaction with aesthetics is also an important measure of the success of the procedure. In a recent publication by Modabber et al., 11 aesthetic outcomes were measured using the visual analog scale (0 100 mm) 3-months post-operatively. Patients who underwent computer-assisted reconstruction had a higher degree of satisfaction with their outer appearance compared to patients where conventional pre-operative planning techniques were used. The mean score was 88.5 mm for the patients who underwent mandible reconstructive surgery using virtual surgical planning (n=5) compared to 67.9 mm for those patients where conventional pre-operative planning techniques were used (n=15) (see Figure 6). 11 The statistical significance of the comparative results was not reported. mm Virtual Surgical Planning Patient outcomes were assessed by Saad et al. using TRUMATCH CMF Solutions technology in complex maxillofacial reconstruction procedures. In this retrospective analysis, PROPLAN CMF Virtual Surgical Planning Service was used in 10 patients with extensive zones of injury (e.g. gunshot wounds and severe osteomyelitis of the mandible) to facilitate the inset of osteocutaneous bone grafts in these difficult patients. 14 No intra-operative complications were associated with the graft harvest, use of the cutting guides, or inset of the multiple bone grafts. Post-operative complications were minimal (one fasciocutaneous graft loss and one wound infection). Post-operative CT scans showed good contouring of the bone grafts, and the plates used in these procedures were adapted well to the native bone and bone grafts. All bone grafts were viable at the 3-month follow up and all patients had functional mandibular range of motion. ECONOMIC VALUE mean VAS score (mm) Conventional Pre-Operative Planning Figure 6. Difference in mean VAS score for aesthetic patient satisfaction (0 mm is least satisfied, 100 mm is most satisfied) 11 Use of virtual surgical planning may reduce surgeon time for pre-operative planning compared to conventional pre-operative planning techniques. For complex CMF procedures, Xia et al. conducted a cost-effectiveness analysis comparing virtual surgical planning to conventional pre-surgical planning methods. 16,17 The results showed lower costs for virtual surgical planning in terms of surgeon time, patient time, and material costs. The authors state that at their facility, the total surgeons time is reduced to min per case for virtual surgical planning procedures in comparison to 9.75 hours for procedures using conventional pre-operative planning methods. 16,17 This reduction in time is largely due to the 6 DePuy Synthes Companies Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief

7 ease of use of the virtual surgical software to plan the procedure compared to time spent measuring and cutting a model by hand to recreate the surgical procedure. Additionally, the authors hypothesized that the maximum potential cost savings of virtual surgical planning would be best realized when a single planning facility serves multiple surgeons, in multiple clinics, and in multiple cities. Virtual surgical planning may have a positive effect on complication rates. It is also reported in the literature by Modabber et al. that the use of virtual surgical planning may offer a positive effect on the complication rate of mandibular reconstruction procedures using fibular bone graft. 12 This reduction in complication rate may result in a reduction in time in the intensive care unit and overall hospital length of stay. 12,13 Both of these factors provide an economic benefit to the hospital. Virtual surgical planning results in a surgical procedure that is more streamlined and efficient than conventional pre-operative planning. As a result of using virtual surgical planning, the reduction in operating room time may result in an increase in procedural volume and an opportunity to offset the cost of the planning session and production of the cutting guide(s). In theory, saving time in the operating room should reduce the overall cost of surgery. 14 Virtual surgical planning allows the case to be more streamlined and should result in shorter cases. 13 The operating room time savings reported in the literature for mandible reconstruction cases using virtual surgical planning is quite variable. Published studies report operating room time savings ranging from 21.2 min 12 to 102 min 6 depending on the complexity of the surgery. These operating room efficiencies were evaluated in a recent study published by Antony et al. 3 This paper reports early results of a prospective study evaluating the use of virtual surgical planning in patients who underwent mandibular reconstruction. The authors found that the use of virtual surgical planning saved operating room time compared to conventional pre-operative planning techniques by eliminating the need for intraoperative plate bending and accelerating the steps involved with contouring and placing the fibular graft. 3 These findings are summarized in Figure 7 below. When virtual surgical planning methods are used, plate bending becomes a pre-operative event, generating the fibular osteotomy is greatly accelerated because the need for intra-operative freehand contouring is eliminated, and the fibular graft is inset with minimal adjustments. All of these factors translate into the potential for considerable saving of intra-operative time and accelerate the learning curve process, marrying virtual experience (effort investment) with efficiency gains in the operating room. 3 Intra-operative Time Savings of Virtual Surgical Planning Compared with Conventional Pre-Operative Planning 3 Exposure of mandible Intraoperative plate bending Mandibular resection Fibular osteotomy and contouring Fibular flap inset/fixation Microvascular anastomosis Final closure Surgical step eliminated Fibular harvest Surgical step accelerated Surgical step accelerated Figure 7: Intra-operative time savings as a result of virtual surgical planning for mandible reconstruction 3 Increased operating room efficiencies should have a positive effect on hospital economics. As the operating room time is reduced, the likelihood increases that the cost of the procedure will also be reduced. Additionally, the reduction in operating room time coupled with the reduction in surgeon pre-surgical planning time may increase surgeon case load and productivity. Virtual Surgical Planning and TRUMATCH CMF Solutions Value Analysis Brief DePuy Synthes Companies 7

8 REFERENCES 1. CSS Surgeon Presentation DJ# 8593B: DePuy Synthes; August Preoperative Planning among ENT, Plastic, and Oral & Maxillofacial Surgeons: A Quantitative Physician Study Report for DePuy Synthes. actintel, LLC April Antony AK, Chen WF, Kolokythas A, Weimer KA, Cohen MN. Use of Virtual Surgery and Stereolithography-Guided Osteotomy for Mandibular Reconstruction with the Free Fibula. Plast Reconstr Surg. 2011;128(5): Fernandes R. Fibula Free Flap in Mandibular Reconstruction. Atlas Oral Maxillofacial Surg Clin N Am. 2006;14: Gateno J, Xia JJ, Teichgraeber JF. New 3-Dimensional Cephalometric Analysis for Orthognathic Surgery. J Oral Maxillofac Surg. 2011(69): Hanasono MM, Skoracki RJ. Computer-Assisted Design and Rapid Prototype Modeling in Microvascular Mandible Reconstruction. Laryngoscope. 2013(123): Hsu SS-P, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichfraeber JF, Zhou X, Xia JJ. Accuracy of a Computer-Aided Surgical Simulation Protocol for Orthognathic Surgery: A Prospective Multicenter Study. J Oral Maxillofac Surg. 2013;71(1): Iorio ML, Masden C, Blake CA, Baker SB. Presurgical Planning and Time Efficiency in Orthognathic Surgery: The Use of Computer-assisted Surgical Simulation. Plast Reconstr Surg. 2011;128(3):179e-181e. 9. Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-Aided Design and Manufacturing in Craniomaxillofacial Surgery: The New State of the Art. J Craniofac Surg. 2012;23(1): Logan H, Wolfaardt J, Boulanger P, Hodgetts B, Seikaly H. Exploratory Benchtop Study Evaluating the Use of Surgical Design and Simulation in Fibula Free Flap Mandibular Reconstruction. J Otolaryngol Head Neck Surg. 2013;42(1). 11. Modabber A, Gerressen M, Stiller MB, Noroozi N, Fuglein A, Holzle F, Riediger D, Ghassemi A. Computer-assisted Mandibular Reconstruction with Vascularized Iliac Crest Bone Graft. Aesth Plast Surg. 2012(36): Modabber A, Legros C, Rana M, Gerressen M, Riediger D, Ghassemi A. Evaluation of Computer-Assisted Jaw Reconstruction with Free Vascularized Fibular Flap Compared to Conventional Surgery: A Clinical Pilot Study. Int J Med Robotics Comput Assist Surg. 2011; 8(2): Paleologos TS, Wadley JP, Kitchen ND, Thomas DGT. Clinical Utility and Costeffectiveness of Interactive Image-guided Craniotomy: Clinical Comparison between Conventional and Image-guided Meningioma Surgery. Neurosurgery 2000; 47: Saad A, Winters R, Wise MW, Dupin CL, Hilaire HS. Virtual Surgical Planning in Complex Composite Maxillofacial Reconstruction. Plast Reconstr Surg. 2013;132(3): Seruya M, Fisher M, Rodriguez ED. Computer-Assisted versus Conventional Free Fibula Flap Technique for Craniofacial Reconstruction: An Outcomes Comparison. Plast Reconstr Surg. 2013;132(5): Xia JJ, Gateno J, Teichgraeber JF. A New Clinical Protocol to Evaluate Cranio-maxillofacial Deformity and to Plan Surgical Correction. J Oral Maxillofac Surg. 2009;67(10): Xia JJ, Phillips CV, Gateno J, Teichgraeber JF, Christensen AM, Gliddon MJ, Lemoine JJ, Liebschner MAK. Cost-Effectiveness Analysis for Computer-Aided Surgical Simulation in Complex Cranio-Maxillofacial Surgery. J Oral Maxillofac Surg. 2006(64): Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor TD, Lasky RE, English JD, Kau CH, McGrory KR. Outcome Study of Computer-Aided Surgical Simulation in the Treatment of Patients with Craniomaxillofacial Deformities. J Oral Maxillofac Surg. 2011(69): Zinser MJ, Sailer HF, Ritter L, Braumann B, Maegele M, Zoller JE. A Paradigm Shift in Orthognathic Surgery? A Comparison of Navigation, Computer-Aided Designed/Computer-Aided Manufactured Splints, and "Classic" Intermaxillary Splints to Surgical Transfer of Virtual Orthognathic Planning. J Oral Maxillofac Surg. 2013;71(12):2151.e e21. The third party trademarks used herein are trademarks of their respective owners. PROPLAN CMF products and services manufactured by For more information, contact your DePuy Synthes CMF sales representative or call Distributed by (United States): DePuy Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) DePuy Synthes All rights reserved. DSUS/CMF/0414/0045(1)a(1) 8/15 DV