| Literature DB >> 32762378 |
Cesar D Lopez1, Venkat Boddapati1, Nathan J Lee1, Marc D Dyrszka1, Zeeshan M Sardar1, Ronald A Lehman1, Lawrence G Lenke1.
Abstract
STUDYEntities:
Keywords: 3D printing; additive manufacturing; adult spinal deformity; deformity correction; rapid prototyping; spine surgery; three-dimensional printing
Year: 2020 PMID: 32762378 PMCID: PMC8258819 DOI: 10.1177/2192568220944170
Source DB: PubMed Journal: Global Spine J ISSN: 2192-5682
Figure 1.PRISMA flow diagram of included studies.
Summary of 3DP Screw Drill Template Studies.
| Study | 3DP type | Comparison | Improvement in screw placement accuracy | Reduced operating time | Reduced blood loss | Reduced radiation exposure | % Mean deformity correction | Screw placement accuracy >90% | Complications | 3DP beneficial result | Conclusions/results |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Wang YT et al, 2016 | SLS | Fluoroscopic guidance | — | Y | Y | — | 90.9 | — | None | Y | Photosensitive resin models can guide the drilling of pedicle screws during surgery. No pedicle penetrations or screw misplacement occurred. |
| Pijpker et al, 2018 | SLA | — | — | — | — | — | 70.3 | — | None | Y | Assisted by 3D-printed individualized osteotomy-guiding templates, the kyphosis was successfully reduced with satisfactory correction of the kyphoscoliosis. |
| D’Urso et al, 2005 | SLA | Navigation based | — | Y | — | — | — | Y | None | Y | Accurate screw placement was confirmed with postoperative CT scanning. Operating time was reduced, as less reliance on intraoperative radiograph was necessary. |
| Yang et al, 2015 | SLS | Free hand | N | Y | Y | — | 59.5 | N | None | Y | There did not appear to be a benefit to using this technology with regard to complication rate and postoperative radiological outcomes; however, 3D technology could reduce the misplacement rate in patients whose preoperative mean Cobb angle was >50°. Besides, it also increased the patients’ hospital cost. |
| Mohar et al, 2015 | SLA | — | — | — | — | — | — | Y | None | Y | The guidance aid of specific rapid prototyping 3D templates shows high accuracy of the thoracic pedicle screw placement in spinal deformities. |
| Liu et al, 2017 | SLA | Free hand | Y | Y | — | — | 67.1 | Y | None | Y | With the application of multilevel template, incidence of cortex perforation in severe and rigid scoliosis decreased and 3DP is, therefore, potentially applicable in clinical practice. |
| Azimifar et al, 2017 | SLA, FDM | — | Y | — | — | — | — | Y | None | Y | The proposed template significantly reduced screw misplacements, increased stability, and decreased the sliding & the intervention invasiveness. |
| Zhang et al, 2017 | FDM | Navigation based | — | Y | — | — | 70.5 | Y | None | Y | 3DP-assisted selective segmental pedicle screws can obtain accurate, safe, and perfect outcomes in the treatment of scoliosis through improving the correction rate and shortening the operation time. |
| Pan et al, 2018 | SLA | Free hand | Y | N | — | — | 55 | Y | None | Y | The drill guide template technique has potential to offer more accurate and thus safer placement of pedicle screws than free-hand technique in the treatment of severe scoliosis. |
| Tan et al., 2018 | SLA | – | Y | – | – | – | -- | Y | None | Y | 3D-printed spinal model aids free-hand pedicle screw insertion in patients with complex spinal deformity. It can help spine surgeons to better understand and visualize the complex and altered spinal anatomy in severe spinal deformity. |
| Cecchinato et al, 2019 | SLS | Free hand | Y | N | — | Y | — | Y | None | Y | Patient-specific, 3D-printed pedicle screw guides increase safety in a wide spectrum of deformity conditions by reducing significantly the incidence of pedicle screw malpositioning compared with the standard free-hand technique, and it reduced the intraoperative exposure to radiation and the surgical time of the implantation phase. However, the production time (4-6 weeks) is significantly longer than other 3DP studies. |
| Luo et al, 2019 | SLA | Free hand | Y | Y | — | — | 63 | Y | 1 | Y | Accuracy of the surgical technique using spinal 3D printing combined with pedicle guider technology in patients with severe congenital scoliosis was higher than the accuracy of the free-hand technique. In addition, it appeared to shorten operative time. |
| Lu et al, 2012 | SLA | Fluoroscopic guidance | — | Y | — | Y | 71.1 | Y | None | Y | 3DP template significantly reduces the operation time and radiation exposure for the members of the surgical team, making it a practical, simple, and safe method. The potential use of a navigational template to insert thoracic pedicle screws in scoliosis is promising, and successfully reduced the perforation rate and insertion angle errors, demonstrating clear advantage in safe and accurate pedicle screw placement of scoliosis surgery. |
| Takemoto et al, 2016 | SLM | — | — | — | — | — | — | Y | None | Y | This study provides a useful design concept for the development and introduction of patient-specific navigational templates for placing pedicle screws. |
| Otsuki et al, 2016 | SLM | — | — | — | — | — | — | Y | None | Y | Using 3DP guides, all screws were inserted correctly without any complications, and can be applied not only in primary spine-surgery cases but also in revision surgeries. |
| Zhang et al, 2018 | SLA | — | — | — | — | — | 54.2 | — | None | Y | Segmental pedicle screw instrumentation was performed under 3-dimensional printing assistance. |
| Garg et al, 2019 | FDM | Free hand | Y | Y | Y | Y | — | Y | None | Y | Developing these patient-specific drill templates will enable spine surgeons to treat deformities with ease and safety. |
| Putzier et al, 2017 | SLS | — | — | — | — | — | 91 | Y | None | Y | Custom-made positioning guide is a feasible navigational tool that permits a safe and accurate implantation of pedicle screws in patients with severe scoliosis. |
| Sugawara et al, 2013 | SLA | Navigation based | — | Y | — | Y | — | — | None | Y | The multistep, patient-specific screw guide template system is useful for intraoperative pedicle screw navigation in the thoracic spine. This simple and economical method can improve the accuracy of pedicle screw insertion and reduce the operating time and radiation exposure of spinal fixation surgery. |
| Wang D et al, 2016 | SLM | — | — | — | — | — | — | — | None | Y | Compared with the traditional technology of screw insertion, the use of the surgical metal template enabled the screws to be inserted more easily and accurately during spinal surgery. |
| Mokawen et al, 2019 | SLM | — | — | — | — | — | — | — | None | Y | SiCaP-packed 3D-printed lamellar titanium cages provided excellent rates of solid fusion in TLIF and LLIF surgeries with notable improvements in patient-reported outcomes. |
| Marengo et al, 2019 | SLS | — | — | — | — | Y | — | N | None | Y | The patient-matched guide for posterior CBT screw placement could improve placement accuracy and decrease the risk of nerve damage. |
Abbreviations: 3DP, 3-dimensional printing; SLA, stereolithography; SLS, selective laser sintering; SLM, selective laser melting; FDM, fused deposition modeling; TLIF, transforaminal lumbar interbody fusion; LLIF, lateral lumbar interbody fusion; Y, yes; N, no.
Figure 2.Sample images of custom 3D printed pedicle screw guides. Figure A shows sterile, back table preparation of all 3D printed guides for a specific patient, B shows one specific guide being placed at planned instrumented level, C shows a pedicle tract being drilled with orientation provided by the custom 3D printed guide. All figures were provided courtesy of Medacta International MySpine (Memphis, TN).
Summary of 3-Dimensional Printing (3DP) Presurgical Planning Studies.
| Study | Primary outcome measure(s) | Secondary outcome measures | Improved presurgical planning | Conclusions/results |
|---|---|---|---|---|
| D’Urso et al, 2005 | Accurate screw placement, operating time, patient surveys | — | Y | The biomodels were found to be highly accurate and of great assistance in the planning and execution of the surgery. |
| Coote et al, 2019 | Clinical outcomes, patient satisfaction | Operating time, blood loss, complications | Y | 3D models can not only improve preoperative planning and provide opportunities to rehearse for complex procedures, but they can also improve consultations with patients. |
| Guarino et al, 2007 | Surgeon questionnaire responses | Operating time | Y | Provides significant benefits for complex surgeries of the pediatric spine and pelvis in the areas of preoperative planning, intrasurgical navigation, and communication with patients. A reduction in operating time may also be expected for cases of congenital scoliosis/kyphosis. However, production costs may vary, ranging up to $2500. |
| Yang et al, 2011 | Screw placement accuracy, operating time, blood loss, deformity correction | Complications/implant failures | Y | Beneficial for preoperative planning and intraoperative reference and allows satisfactory correction of complex thoracic deformities. |
| Mao et al., 2010 | Postoperative scoliosis Cobb angle | Complications | Y | Compared to spinal radiography, CT, MRI, and even 3D spinal reconstruction, the computer-designed polystyrene model served as a more tactile visual aid to confirm the positions of anatomical landmarks, helping the surgeon plan the operation and improve the accuracy of pedicle screw insertion. |
| West et al, 2014 | Imaging | — | Y | 3DP ultrasound phantom models that are derived directly from patient anatomy have strong potential as preprocedural planning tools in cases involving pathologies, implants, or abnormal anatomies. |
| Kim et al, 2016 | Bone union/clinical outcomes | — | Y | Preoperative 3D printing was useful for understanding the bony architecture and nonunion. |
| Mobbs et al, 2017 | Bone union/clinical outcomes | Operating time, blood loss | Y | 3DP models can ease the difficulty of complex spinal surgery and shorten procedure time. |
| Izatt et al, 2007 | Surgeon survey results about imaging | Operating time | Y | Surgeons stated that the anatomical details were better visible on the 3DP biomodel than on other imaging modalities and reduced operating time by a mean of 22% in deformity procedures. However, cost is high, ranging from $900 to $1500. |
| Wang YT et al, 2016 | Operating time, blood loss | Complications (screw misplacement, pedicle penetration) | Y | The tactile models from 3D printing allow direct observation and measurement, helping orthopedists to have accurate morphometric information to provide personalized surgical planning and better communication with the patient and coworkers. |
| Pijpker et al, 2018 | Kyphosis correction/clinical outcomes | — | Y | 3DP planning model facilitated a detailed preoperative evaluation, greater insight into the case-specific anatomy, and accurate planning of the required correction. |
| Yang et al, 2015 | Operating time, blood loss, postoperative hemoglobin, postoperative complications, and length of hospital stay. | Radiographic assessment of screw placement, postoperative Cobb angle, coronal balance, sagittal vertical axis, thoracic kyphosis, and lumbar lordosis | N | There did not appear to be a benefit to using this technology with respect to complication rate and postoperative radiological outcomes; it also increased the patients’ hospital cost. |
| Mohar et al, 2015 | Screw placement accuracy | Screw position/trajectory | Y | After screw position was planned, 3D printing of a biocompatible template, the average difference in trajectory between planned and actual screw showed high accuracy of the thoracic pedicle screw placement in spinal deformities. |
| Zhang et al, 2017 | Screw placement accuracy | Deformity correction, complications | Y | The placement site, direction and length of pedicle screws were consistent with those in 3D printing model. Cobb angle of major thoracic curve after operation were significantly improved compared with preoperation ( |
| Wang H et al, 2017 | Screw placement accuracy, bony healing | Operating time, blood loss, complications | Y | 3DP technology can increase the accuracy and safety of operation, and can be provide more detailed preoperative, intuitive, three-dimensional, realistic personalized operation scheme. It can reduce the operation trauma and achieve rapid recovery after operation. |
| Lu et al, 2012 | Screw Placement Accuracy | Operating time, radiation exposure | Y | Provides capability to preoperatively prepare and customize the surgical plan based on the unique morphology of each patient’s pedicle. This method significantly reduces the operation time and radiation exposure for the members of the surgical team. |
| Tan et al, 2018 | Screw placement accuracy | Operating time, blood loss, complications/screw misplacements | Y | The 3D-printed spinal model is a helpful tool for surgical planning and freehand pedicle screw insertion in patients with complex spinal deformity. It can help spine surgeons to better understand and visualize the complex and altered spinal anatomy in severe spinal deformity. |
| Garg et al, 2019 | Screw violation | Surgical time, blood loss, radiation exposure (number of shots required) | Y | 3DP model successful in determining and planning the proper pedicle screw trajectory. |
| Putzier et al, 2017 | Screw placement accuracy | Deformity correction, clinical complications | Y | The preoperative planning process, specialized algorithms to create patient-matched vertebral models, and guides for treating asymmetric and severely rotated vertebrae with small pedicles positively impact the surgeon, the patient, and the hospital team. |
| Marengo et al, 2019 | Screw placement accuracy | Complications/screw misplacements/pedicle penetration | Y | The use of 3DP devices for cortical bone trajectory (CBT) fixation allows not only a customized plan but could also improve placement accuracy and decrease the risk of nerve damage. Furthermore, the need of fluoroscopy could potentially be set down to zero. |
Figure 3.3-Dimensional printed model of complex kyphoscoliosis.
Summary of 3-Dimensional Printing (3DP) Training, Education, and Team Communication Studies.
| Study | 3DP intervention | Patient satisfaction/understanding | Team communication | Surgical education | Reduced operating time | Conclusions/findings |
|---|---|---|---|---|---|---|
| D’Urso et al, 2005 | 3DP spine model | Improved | Improved | — | Y | Patients stated that the biomodels improved informed consent and communication, and responded favorably to the biomodel when it was used to explain the pathology and operative plan, which allowed them to achieve a far greater understanding of their problem, the surgical plan, and associated risks. |
| Coote et al, 2019 | 3DP spine model | Improved | Improved | — | Y | Enhance visualization of patient anatomy, allowing patients and their families who lack medical training to interpret and understand cross-sectional anatomy, which in our experience, enhanced the consultations. |
| Guarino et al, 2007 | 3DP spine model | Improved | Improved | Improved | Y | Surgeons found 3DP models useful for preoperative planning, reference during surgery, communication with patients, and for increasing the safety of the procedure. |
| Yang et al, 2011 | 3DP spine model | Improved | Improved | Improved | — | Helpful as a communication tool, providing patients with a better appreciation of their condition, details of the planned surgical procedure and the subsequent risks involved while facilitating communication within the surgical team. Surgeons appreciated the “hands-on” aspect provided by the models. |
| Mao et al, 2010 | 3DP spine model | — | Improved | — | — | Allowed 3D observation and measurement of the deformities directly, which helped the surgeon to perform morphological assessment and communicate with the patient and colleagues. |
| Li et al, 2018 | 3DP spine model | — | — | Improved | — | 3D printed lumbosacral spine phantom with realistic spondylosis can be made to facilitate novice training in minimally invasive spine procedures, although at a high cost ($5400) and setup time (1 month). |
| West et al, 2014 | 3DP spine model | — | — | Improved | — | 3DP ultrasound phantoms that are derived directly from patient anatomy have strong potential as learning tools and preprocedural planning tools in cases involving pathologies, implants, or abnormal anatomies. |
Summary of 3-Dimensional Printing (3DP) Production Type, Materials, Costs, and Time.
| Study, author (year) | 3DP type | Material(s) | Average cost estimate (USD) | Average time estimate (hours) |
|---|---|---|---|---|
| Izatt et al (2007) | SLA | Polymer | 1200.00 | 14 |
| Wang YT et al (2016) | SLS | Polymer | 361.50 | 18 |
| Pijpker et al (2018) | SLA | Polyamide | 175.00 | 24 |
| Coote et al (2019) | SLA | Photoreactive resin | 447.50 | 72 |
| Guarino et al (2007) | SLA, FDM | Polymer | 1550.00 | |
| Mao et al (2010) | SLA | Polystyrene | 289.00 | 10.5 |
| Li et al (2018) | SLA | Calcium sulfate hemihydrate | 5400.00 | 720 |
| West et al (2014) | SLA | Resin | 677.71 | 24 |
| Liu et al (2017) | SLA | Resin | 290.00 | 36 |
| Pan et al (2018) | SLA | Polycarbonate | — | 72 |
| Cecchinato et al (2019) | SLS/MySpine | Unspecified | — | 840 |
| Takemoto et al (2016) | SLM | Titanium | 1000.00 | 24 |
| Garg et al (2019) | FDM | Unspecified | — | 11 |
| Putzier et al (2017) | SLS/MySpine | Polyamide | — | 168 |
| Sugawara et al (2013) | SLA | acrylate | 250.00 | 60 |
| Wang D et al (2016) | SLM | ABS, stainless steel | — | — |
| Mokawen et al (2019) | SLM | Titanium, SiCaP | — | — |
| Marengo et al (2019) | SLS | Polyamide | — | — |
| Simple average | 1058.25 | 149.54 |
Abbreviations: SLA, stereolithography; SLS, selective laser sintering; SLS/MySpine, MySpine 3DP guide produced using SLS technology; SLM, selective laser melting; FDM, fused deposition modeling; ABS, acrylonitrile butadiene styrene; SiCaP, Silicate-substituted calcium phosphate.