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Cong B, Zhang H. Innovative 3D printing technologies and advanced materials revolutionizing orthopedic surgery: current applications and future directions. Front Bioeng Biotechnol 2025; 13:1542179. [PMID: 40008034 PMCID: PMC11850356 DOI: 10.3389/fbioe.2025.1542179] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2024] [Accepted: 01/22/2025] [Indexed: 02/27/2025] Open
Abstract
Three-dimensional (3D) printing has rapidly become a transformative force in orthopedic surgery, enabling the creation of highly customized and precise medical implants and surgical tools. This review aims to provide a more systematic and comprehensive perspective on emerging 3D printing technologies-ranging from extrusion-based methods and bioink printing to powder bed fusion-and the broadening array of materials, including bioactive agents and cell-laden inks. We highlight how these technologies and materials are employed to fabricate patient-specific implants, surgical guides, prosthetics, and advanced tissue engineering scaffolds, significantly enhancing surgical outcomes and patient recovery. Despite notable progress, the field faces challenges such as optimizing mechanical properties, ensuring structural integrity, addressing regulatory complexities across different regions, and considering environmental impacts and cost barriers, especially in low-resource settings. Looking ahead, innovations in smart materials and functionally graded materials (FGMs), along with advancements in bioprinting, hold promise for overcoming these obstacles and expanding the capabilities of 3D printing in orthopedics. This review underscores the pivotal role of interdisciplinary collaboration and ongoing research in harnessing the full potential of additive manufacturing, ultimately paving the way for more effective, personalized, and durable orthopedic solutions that improve patient quality of life.
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Affiliation(s)
- Bo Cong
- Department of Orthopedics, Yantaishan Hospital Affiliated to Binzhou Medical University, Yantai, Shandong, China
- Yantai Key Laboratory for Repair and Reconstruction of Bone and Joint, Yantai, Shandong, China
| | - Haiguang Zhang
- Department of Orthopedics, Yantaishan Hospital Affiliated to Binzhou Medical University, Yantai, Shandong, China
- Yantai Key Laboratory for Repair and Reconstruction of Bone and Joint, Yantai, Shandong, China
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Sappey-Marinier E, Beel W, Bonnin MP, Aït-Si-Selmi T. Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2024; 32:3174-3184. [PMID: 38864156 DOI: 10.1002/ksa.12233] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2024] [Revised: 04/24/2024] [Accepted: 04/27/2024] [Indexed: 06/13/2024]
Abstract
PURPOSE The purpose of this pilot cross-sectional study was to compare the operating room (OR) efficiency and intraoperative staff task load when performing individualised versus off-the-shelf (OTS) total knee arthroplasty (TKA). METHODS A consecutive series of 28 patients randomised (1:1) to receive either OTS TKA or individualised TKA were included. The OR staff workload was assessed with the NASA Task Load Index (TLX), a subjective grading system assessing mental demand, physical demand, temporal demand, performance, effort and frustration on a scale from 0 (very low) to 20 (very high). The time for patient preparation, surgical time, closure and total OR time was recorded to assess OR efficiency. Effect sizes of differences between OTS and individualised TKA were expressed as mean differences (MDs) with 95% confidence intervals (CIs). RESULTS Patients in both cohorts were similar in age (OTS vs. individualised TKA (median [IQR]), 67 [63-76] vs. 71 [68-79]; p = 0.207) and body mass index (BMI) (29 [24-33] vs. 29 [26-31]; p = 0.807), and there were no significant differences in other preoperative characteristics. The OR staff perceived individualised TKA as less demanding than OTS TKA: Individualised TKA was rated significantly better across the six domains of the NASA TLX: mental demand by 5.6 points, physical demand by 6.3 points, temporal demand by 5.3 points, performance by 3.6 points, effort by 5.9 points and frustration by 5.8 points. Individualised TKA resulted in statistically significantly shorter mean total OR time (MD, 10 min; p = 0.018). CONCLUSION The staff in the OR found that individualised TKA is less mentally, physically and temporally demanding than OTS TKA. The average total time spent in the OR during individualised TKA is 10 min less than during OTS TKA. CLINICAL TRIAL REGISTRATION This study constitutes a part of a larger registered randomised controlled trial comparing patient satisfaction following OTS versus individualised TKA (NCT04460989). LEVEL OF EVIDENCE Level III.
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Affiliation(s)
| | - Wouter Beel
- Ramsay Santé, Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Lyon, France
| | - Michel P Bonnin
- Ramsay Santé, Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Lyon, France
| | - Tarik Aït-Si-Selmi
- Ramsay Santé, Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Lyon, France
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Heliere G, David G, Cypel S, Steiger V, Ducellier F, Rony L. Does two dimensional templating allow for the use of reduced-size ancillaries in total hip arthroplasty? INTERNATIONAL ORTHOPAEDICS 2024; 48:2553-2559. [PMID: 39172270 PMCID: PMC11422433 DOI: 10.1007/s00264-024-06276-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/18/2024] [Accepted: 08/09/2024] [Indexed: 08/23/2024]
Abstract
PURPOSE Rising costs in healthcare for total hip arthroplasty (THA) mean that new solutions must be considered, such as the use of single-use ancillaries (SUA). The goal of this study was to assess the accuracy of 2D templating in primary THA for the use of reduced-size SUA. Our hypothesis was that the accuracy of 2D templating in primary THA would be higher than 95%, give or take two sizes. METHOD This single-centre prospective study included all primary THAs performed over two years. Templating was carried out using 2D templating on anteroposterior pelvic X-rays. The template sizes were compared to the implant sizes. The primary endpoint was the rate of coincidence between digitally templated estimates and the actual implant sizes. The secondary endpoint was the difference of accuracy based on patient parameters. RESULTS We analysed 512 cases of THA. Accuracy within two sizes was 96.9% for acetabular implants and 98.5% for femoral implants. Accuracy was below the 95% threshold only in patients under 55 and over 85 years old. A BMI above 30.0 kg/m2 significantly reduced accuracy but did not fall below the 95% threshold. The operated hip, the type of implant, and the operative indication did not significantly influence templating accuracy. CONCLUSION Using reduced-size SUA with five rasps and five reamers depending on template sizes means that THA can be performed in more than 95% of cases allowing the use of compact single use ancillaries.
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Affiliation(s)
- Gregoire Heliere
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France.
| | - Guillaume David
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France
| | - Sarah Cypel
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France
| | - Vincent Steiger
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France
| | - Florian Ducellier
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France
| | - Louis Rony
- Department of Orthopaedic Surgery, CHU d'Angers, 4, rue Larrey, Angers Cedex 9, 49933, France
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Mounsef PJ, Aita R, Skaik K, Addab S, Hamdy RC. Three-dimensional-printing-guided preoperative planning of upper and lower extremity pediatric orthopedic surgeries: A systematic review of surgical outcomes. J Child Orthop 2024; 18:360-371. [PMID: 39100975 PMCID: PMC11295370 DOI: 10.1177/18632521241264183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2024] [Accepted: 06/10/2024] [Indexed: 08/06/2024] Open
Abstract
Purpose Three-dimensional printing has evolved into a cost-effective and accessible tool. In orthopedic surgery, creating patient-specific anatomical models and instrumentation improves visualization and surgical accuracy. In pediatric orthopedics, three-dimensional printing reduces operating time, radiation exposure, and blood loss by enhancing surgical efficacy. This review compares outcomes of three-dimensional printing-assisted surgeries with conventional surgeries for upper and lower extremity pediatric surgeries. Methods A complete search of medical literature up to August 2023, using Ovid Medline, EMBASE, Scopus, Web of Science, and Cochrane Library was conducted in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Broad search terms included "pediatrics," "orthopedic," and "3D-printing." Eligible studies were assessed for intraoperative time, blood loss, and fluoroscopy exposure. Results Out of 3299 initially identified articles, 14 articles met inclusion criteria. These studies included 409 pediatric patients, with ages averaging 9.51 years. The majority were retrospective studies (nine), with four prospective and one experimental study. Studies primarily utilized three-dimensional printing for navigation templates and implants. Results showed significant reductions in operative time, blood loss, and radiation exposure with three-dimensional printing. Complication occurrences were generally lower in three-dimensional printing surgeries, but there was no statistical significance. Conclusions Three-dimensional printing is an emerging technology in the field of orthopedics, and it is primarily used for preoperative planning. For pediatric upper and lower extremity surgeries, three-dimensional printing leads to decreased operating room time, decreased intraoperative blood loss, and reduced radiation exposure. Other uses for three-dimensional printing include education, patient communication, the creation of patient-specific instrumentation and implants. Level of evidence Level III.
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Affiliation(s)
| | | | - Khaled Skaik
- Faculty of Medicine and Health Science, McGill University, Montreal, QC, Canada
| | - Sofia Addab
- Shriners Hospitals for Children – Canada, Montreal, QC, Canada
| | - Reggie Charles Hamdy
- Faculty of Medicine and Health Science, McGill University, Montreal, QC, Canada
- Shriners Hospitals for Children – Canada, Montreal, QC, Canada
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Dorling IM, Geenen L, Heymans MJLF, Most J, Boonen B, Schotanus MGM. Cost-effectiveness of patient specific vs conventional instrumentation for total knee arthroplasty: A systematic review and meta-analysis. World J Orthop 2023; 14:458-470. [PMID: 37377995 PMCID: PMC10292058 DOI: 10.5312/wjo.v14.i6.458] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2022] [Revised: 04/26/2023] [Accepted: 05/15/2023] [Indexed: 06/19/2023] Open
Abstract
BACKGROUND Over the past years, patient specific instrumentation (PSI) for total knee arthroplasty (TKA) has been implemented and routinely used. No clear answer has been given on its associated cost and cost-effectiveness when compared to conventional instrumentation (CI) for TKA.
AIM To compare the cost and cost-effectiveness of PSI TKA compared to CI TKA.
METHODS A literature search was performed in healthcare, economical healthcare, and medical databases (MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Library, EconLit). It was conducted in April 2021 and again in January 2022. Relevant literature included randomised controlled trials, retrospective studies, prospective studies, observational studies, and case control studies. All studies were assessed on methodological quality. Relevant outcomes included incremental cost-effectiveness ratio, quality-adjusted life years, total costs, imaging costs, production costs, sterilization associated costs, surgery duration costs and readmission rate costs. All eligible studies were assessed for risk of bias. Meta-analysis was performed for outcomes with sufficient data.
RESULTS Thirty-two studies were included into the systematic review. Two were included in the meta-analysis. 3994 PSI TKAs and 13267 CI TKAs were included in the sample size. The methodological quality of the included studies, based on Consensus on Health Economic Criteria-scores and risk of bias, ranged from average to good. PSI TKA costs less than CI TKA when considering mean operating room time and its associated costs and tray sterilization per patient case. PSI TKA costs more compared to CI TKA when considering imaging and production costs. Considering total costs per patient case, PSI TKA is more expensive in comparison to CI TKA. Meta-analysis comparing total costs for PSI TKA, and CI TKA showed a significant higher cost for PSI TKA.
CONCLUSION Cost for PSI and CI TKA can differ when considering distinct aspects of their implementation. Total costs per patient case are increased for PSI TKA when compared to CI TKA.
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Affiliation(s)
- Isobel M Dorling
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Lars Geenen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Marion J L F Heymans
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- Zuyderland Academy, Zuyderland Medical Center, Sittard-Geleen 6155 NH, Limburg, Netherlands
| | - Jasper Most
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- School of Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht 6229 ER, Limburg, Netherlands
| | - Bert Boonen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Martijn G M Schotanus
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- School of Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht 6229 ER, Limburg, Netherlands
- Department of Orthopaedic Surgery and Traumatology, Maastricht University Medical Center, Maastricht 6229 HX, Limburg, Netherlands
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Schönthaler W, Dauwe J, Holzer LA. Patient-specific instrumentation in total knee arthroplasty: a review of the current literature. Acta Orthop Belg 2023; 89:299-306. [PMID: 37924556 DOI: 10.52628/89.2.11543] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2023]
Abstract
Total knee arthroplasty (TKA) is one of the most frequently performed interventions in the field of Orthopaedic surgery. Over the last decades the implantation technique has improved continuously. The majority of patients is satisfied with the clinical outcome of TKA. However in various clinical follow-ups, up to 20% of unsatisfied patients can be observed. Periprosthetic infection and aseptic loosening seem to be the most common reasons for failure. Malalignment has been discussed as a cause of aseptic loosening and often leads to revision surgery. In order to increase the precision of implant positioning and alignment, new technologies such as patient-specific instrumentation (PSI) have been developed. Since the introduction of PSI, multiple clinical studies have been performed analyzing the clinical and radiological outcome of TKA with PSI technique. This review covers the recent literature of PSI in respect to surgical accuracy, clinical outcome, time- and cost-effectiveness.
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Hinloopen JH, Puijk R, Nolte PA, Schoones JW, de Ridder R, Pijls BG. The efficacy and safety of patient-specific instrumentation in primary total knee replacement: a systematic review and meta-analysis. Expert Rev Med Devices 2023; 20:245-252. [PMID: 36736371 DOI: 10.1080/17434440.2023.2177152] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
INTRODUCTION Patient-specific instrumentation (PSI) for primary total knee arthroplasty (TKA) surgery has been shown to increase accuracy of component positioning. However, it is unclear whether this also translates to actual benefits for patients in terms of better outcomes (efficacy) or less complications such as revisions (safety). We therefore systematically reviewed the literature to determine the efficacy and safety of PSI in primary TKA. METHODS Randomized controlled trials comparing PSI to non-PSI in primary TKA were included. A random effects model was used with meta-regression in case of heterogeneity. RESULTS Forty-three studies were included with a total of 1816 TKA in the PSI group and 1887 TKA in the control group. There were no clinically relevant differences between the PSI-group and non-PSI group regarding all outcomes. There was considerable heterogeneity: meta-regression analyses showed that the year the study was published was an important effect modifier. Early publications tended to show a positive effect for PSI compared to non-PSI TKA, whereas later studies found the opposite. CONCLUSION Based on evidence of moderate certainty, our study suggested that there were no clinically relevant differences in efficacy and safety between patients treated with PSI TKA and patients treated with non-PSI TKA.
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Affiliation(s)
- J H Hinloopen
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
| | - R Puijk
- Department of Orthopedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands
| | - P A Nolte
- Department of Orthopedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.,Department Oral Cell Biology, Academic Centre for Dentistry (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - J W Schoones
- Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Centre, Leiden, The Netherlands
| | - R de Ridder
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.,Department of Orthopaedics, Reinier Haga Orthopaedic Centre, Zoetermeer, Netherlands
| | - B G Pijls
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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Hickey MD, Masri BA, Hodgson AJ. Can Technology Assistance be Cost Effective in TKA? A Simulation-Based Analysis of a Risk-prioritized, Practice-specific Framework. Clin Orthop Relat Res 2023; 481:157-173. [PMID: 36073992 PMCID: PMC9750678 DOI: 10.1097/corr.0000000000002375] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2022] [Accepted: 08/03/2022] [Indexed: 01/31/2023]
Abstract
BACKGROUND Robotic, navigated, and patient-specific instrumentation (PSI) TKA procedures have been introduced to improve component placement precision and improve implant survivorship and other clinical outcomes. However, the best available evidence has shown that these technologies are ineffective in reducing revision rates in the general TKA patient population. Nonetheless, it seems plausible that these technologies could be an effective and cost-effective means of reducing revision risk in clinical populations that are at an elevated risk of revision because of patient-specific demographics (such as older age at index surgery, elevated BMI, and being a man). Since clinical trials on this topic would need to be very large, a simulation approach could provide insight on which clinical populations would be the most promising for analysis. QUESTIONS/PURPOSES We conducted a simulation-based analysis and asked: (1) Given key demographic parameters characterizing a patient population, together with estimates of the precision achievable with selected forms of technology assistance in TKA, can we estimate the expected distributions of anticipated reductions in lifetime revision risk for that population and the associated improvements in quality-adjusted life years (QALYs) that would be expected to result? (2) Are there realistic practice characteristics (such as combinations of local patient demographics and capital and per-procedure costs) for which applying a per-patient risk-prioritized policy for using technology-assisted TKA could be considered cost-effective based on projected cost savings from reductions in revision rates? METHODS We designed simulations of hypothetical practice-specific clinical scenarios, each characterized by patient volume, patient demographics, and technology-assisted surgical technique, using demographic information drawn from other studies to characterize two contrasting simulated clinical scenarios in which the distributions of factors describing patients undergoing TKA place one population at a comparatively elevated risk of revision (elevated-risk population) and the second at a comparatively reduced risk of revision (lower-risk population). We used results from previous systematic reviews and meta-analyses to estimate the implant precision in coronal plane alignment for patient-specific instrumentation, navigated, and robotic technology. We generated simulated TKA patient populations based on risk estimates from large clinical studies, structured reviews, and meta-analyses and calculated the patient-specific reduction in the revision risk and the change in QALYs attributable to the technology-assisted intervention in each of the two simulated clinical scenarios. We also incorporated a sensitivity analysis, incorporating variations in the effect size of deviations from overall coronal alignment on revision risk and difference in health state utilities acquired through a structured review process. We then simulated the outcomes of 25,000 operations per patient using the precisions associated with the conventional TKA technique, the three technology-assisted techniques, and a hypothetical technology-assisted intervention that could consistently deliver perfectly neutral overall coronal alignment, which is unachievable in practice. A risk-prioritized treatment policy was emulated by ordering the simulated patients from the highest to lowest predicted increase in QALYs, such that simulated patients who would see the greatest increase in the QALYs (and therefore the greatest reduction in lifetime revision risk) were the patients to receive technology-assisted TKA intervention in a practice. We used cost estimates acquired through a structured review process and calculated the net added costs of each of the three technology-assisted techniques as a function of the percent utilization (proportion of patients treated with technology assistance in a practice), factoring in fixed costs, per-procedure variable costs, and savings occurring from the prevention of future revision surgery. Finally, we calculated the incremental cost-effectiveness ratio (ICER) and marginal cost-effectiveness ratio (MCER) for each technology-assisted technique for the two clinical scenarios. We then used a Monte Carlo approach to simulate variations in key patient risk, health state, and economic factors as well as to obtain a distribution of estimates for cost-effectiveness. We considered an intervention to be cost effective if either the ICER or MCER values were below USD/QALY 63,000. RESULTS For the lower-risk population, the median reduction in the revision risk was 0.9% (0.4% to 2.2%, extrema from the sensitivity analysis) and 1.8% (0.9% to 4.4%) for PSI and robotic TKA, respectively, and 1.9% (1.0% to 4.6%) for ideal TKA. In contrast, the median reduction in the revision risk in the elevated-risk clinical scenario was 2.0% (1.2% to 3.4%) and 4.6% (2.7% to 8.5%) for PSI and robotic TKA and 5.1% (3.0% to 9.4%) for ideal TKA. Estimated differences in the cumulative gain in QALYs attributable to technology-assisted TKA ranged from 0.6 (0.2 to 1.8) to 4.0 (1.8 to 10.0) QALYs per 100 patients, depending on the intervention type and clinical scenario. For PSI, we found treating 15% of patients in the lower-risk population and 77% in the elevated-risk population could meet the threshold for being considered cost effective. For navigated TKA systems offering high alignment precision, we found the intervention could meet this threshold for practice sizes of at least 300 patients per year and a percent utilization of 27% in the lower-risk population. In the elevated-risk population, cost-effectiveness could be achieved in practice volumes as small as 100 patients per year with a percent utilization of at least 6%, and cost savings could be achieved with a percent utilization of at least 45%. We found that robotic TKA could only meet the threshold for being considered cost-effectiveness in the lower-risk population if yearly patient volumes exceeded 600 and for a limited range of percent utilization (27% to 32%). However, in the elevated-risk patient population, robotic TKA with high alignment precision could potentially be cost effective for practice sizes as small as 100 patients per year and a percent utilization of at least 20% if a risk-prioritized treatment protocol were used. CONCLUSION Based on these simulations, a selective-use policy for technology-assisted TKA that prioritizes using technology assistance for those patients at a higher risk of revision based on patient-specific factors could potentially meet the cost-effectiveness threshold in selected circumstances (for example, primarily in elevated-risk populations and larger practice sizes). Whether it does meet that threshold would depend significantly on the surgical precision that can be achieved in practice for a given proposed technology as well as on the true local costs of using the proposed technology. We further recommend that any future randomized trials seeking to demonstrate possible effects of technology assistance on revision risk focus on clinical populations that are at higher risk of revision (such as, patient populations that are relatively younger, have higher BMIs, and higher proportions of men). CLINICAL RELEVANCE This study suggests that technology assistance is only likely to prove cost effective in selected circumstances rather than in all clinical populations and practice settings. In general, we project that surgical navigation is most likely to prove cost effective in the widest range of circumstances, that PSI may be cost effective or cost neutral in a moderate range of circumstances, and that robotic surgery is only likely to be cost effective in moderately large practices containing patients who are on average at an intrinsically elevated risk of revision.
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Affiliation(s)
- Matthew D. Hickey
- School of Biomedical Engineering, The University of British Columbia, Vancouver, BC, Canada
| | - Bassam A. Masri
- Department of Orthopaedics, The University of British Columbia, Vancouver, BC, Canada
| | - Antony J. Hodgson
- Department of Mechanical Engineering, The University of British Columbia, Vancouver, BC, Canada
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Morgan S, Barriga J, Dadia S, Merose O, Sternheim A, Snir N. Three dimensional printing as an aid for pre-operative planning in complex cases of total joint arthroplasty: A case series. J Orthop 2022; 34:142-146. [PMID: 36072761 PMCID: PMC9441292 DOI: 10.1016/j.jor.2022.08.015] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/29/2022] [Revised: 08/10/2022] [Accepted: 08/11/2022] [Indexed: 11/25/2022] Open
Abstract
Purpose Digital templating is an essential aspect of pre-operative planning for total joint arthroplasty procedures. For complex cases of joint reconstruction, the standard templating software is insufficient to achieve the desired accuracy. 3D printing significantly aids the pre-operative planning in complicated cases of joint reconstruction and offers immense potential towards improving outcomes in these cases. The purpose of the present study is to present the various ways in which 3D printing has aided our department in facilitating complex cases of lower extremity reconstruction. Methods Data was retrospectively retrieved for all patients that underwent total hip arthroplasty (THA) and total knee arthroplasty (TKA) with the aid of 3D printing technology at our institution between January 2016-February 2021. Patient pain was determined before and after surgery using the visual analogue scale (VAS). Patient reported outcome measures (PROMs) were additionally analyzed using the hip disability and osteoarthritis outcome score (HOOS) and knee injury and osteoarthritis outcome score (KOOS). Results The final study population consisted of 39 patients that underwent TKA or THA procedures with the use of 3D printing. Twenty-four (61.5%) of the surgeries in the study were THA procedures, whereas 15 (38.5%) were TKA procedures. The average VAS for patients reduced from 8.4% before surgery to 5.4% after surgery (p < 0.001). The mean KOOS of patients that underwent TKA was 17.33 ± 9.33 (43%) and the mean HOOS of patients that underwent THA was 13.79 ± 6.6 (42%). Conclusions The following series demonstrates the ability by which 3D printing facilitates complex cases of hip and knee reconstruction. 3D printing offers an improvement in understanding of patient specific anatomy, enhancing patient outcomes. Departments should consider the use of 3D printing technology as an adjunct when performing complex cases of lower extremity reconstruction.
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Affiliation(s)
- Samuel Morgan
- Sackler Faculty of Medicine, Tel Aviv University, Israel
| | - Juan Barriga
- Department of Orthopaedics, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Israel
| | - Solomon Dadia
- Sackler Faculty of Medicine, Tel Aviv University, Israel
- National Unit of Orthopaedic Oncology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Israel
| | - Omri Merose
- Sackler Faculty of Medicine, Tel Aviv University, Israel
- National Unit of Orthopaedic Oncology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Israel
| | - Amir Sternheim
- Sackler Faculty of Medicine, Tel Aviv University, Israel
- National Unit of Orthopaedic Oncology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Israel
| | - Nimrod Snir
- Sackler Faculty of Medicine, Tel Aviv University, Israel
- Division of Adult Joint Reconstruction, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Israel
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Ly JA, Wang WL, Liss FE, Ilyas AM, Jones CM. Comparative Cost Analysis of Single-use Sterile versus Reprocessed Distal Radius Volar Plate Sets. THE ARCHIVES OF BONE AND JOINT SURGERY 2022; 10:420-425. [PMID: 35755785 PMCID: PMC9194709 DOI: 10.22038/abjs.2021.57852.2872] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Received: 04/25/2021] [Accepted: 10/06/2021] [Indexed: 01/24/2023]
Abstract
BACKGROUND With the rise in distal radius fracture (DRF) incidence and treatment through open reduction internal fixation, there are increasing concerns in the current medical cost containment climate. To help reduce costs, manufacturers are introducing sterile packed kits. The purpose of this study is to compare the costs of the single use kit (SK) against conventional reprocessed DRF surgical sets (RS). METHODS A four-year retrospective review at three surgical centers was performed to determine a company's RS average sterilization and processing costs. RS instrumentation cost was estimated by straight-line depreciation from the original purchase price. RS implant costs were calculated from the list price. SK list cost was obtained from the same company. Incidence of surgical delays was estimated by a survey of 23 hand surgeons and cost of delays was obtained from surgical center reports. Sensitivity analysis on delay frequency was performed to assess a range of overall costs. RESULTS OR delays were estimated at one out of 100 cases, with an average cost of $11 per case. For RS, average instruments, implants, and sterilization costs per case was $47, $2882, and $39. The total RS cost of $2,978 and the SK was $1,667 with a difference of $1,313 per case. CONCLUSION RS was found to cost $1,313 more per case than the SK in an ambulatory surgical setting and potentially more cost effective. Ultimately, pricing is highly variable at each center based on negotiated and contractual pricing.
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Affiliation(s)
- Justin A. Ly
- Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA
| | - William L. Wang
- Department of Orthopaedic Surgery, Sidney Kimmel College at Thomas Jefferson University, Philadelphia, PA, USA
| | - Frederic E. Liss
- Rothman Orthopaedic Institute at Thomas Jefferson University,Philadelphia, PA, USA
| | - Asif M. Ilyas
- Rothman Orthopaedic Institute at Thomas Jefferson University,Philadelphia, PA, USA
| | - Christopher M. Jones
- Rothman Orthopaedic Institute at Thomas Jefferson University,Philadelphia, PA, USA
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CT-based patient-specific instrumentation for total knee arthroplasty in over 700 cases: single-use instruments are as accurate as standard instruments. Knee Surg Sports Traumatol Arthrosc 2022; 30:447-455. [PMID: 32676744 PMCID: PMC8866287 DOI: 10.1007/s00167-020-06150-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2020] [Accepted: 07/10/2020] [Indexed: 11/25/2022]
Abstract
PURPOSE Efforts in total knee arthroplasty are made to improve accuracy for a correct leg axis and reduce component malpositioning using patient-specific instruments. It was hypothesized that use of patient-specific instruments (vs. computer-navigated and conventional techniques) will reduce the number of outliers. Our second hypothesis was that single-use instrumentation will lead to the same accuracy compared to patient-specific instruments made of metal. METHODS 708 primary total knee arthroplasties between 2014 and 2018 using computer tomography (CT)-based patient-specific cutting block technique and a preoperative planning protocol were retrospectively reviewed. Preoperative data [hip-knee-angle (HKA), lateral distal femoral angle (LDFA), medial proximal tibial angle (MPTA), tibial slope, femoral component flexion] was compared to postoperative performed standard radiological follow-up X-rays. Differences of > 3° between measurements were defined as outliers. RESULTS Overall 500 prostheses using standard instrumentation and 208 prostheses using single-use instruments were implanted. Preoperative HKA axes (- 1.2°; p < 0.001), femoral component flexion (Δ 0.8°, p < 0.001), LDFA (Δ - 1.5°, p < 0.001), MPTA (Δ - 0.5°, p < 0.001) and tibial posterior slopes (Δ 0.5°, p < 0.001), respectively, were different from postoperative axes. More outliers occurred using standard (vs. single-use) instruments (p < 0.001) regarding postoperative HKA (ranges of standard- vs. single-use: instruments: HKA 178.0°-180.5° vs. 178.0°-180.5°, femoral component flexion 0.0°-6.0° vs. 0.0°-4.5°, LDFA 90.0°-91.0° vs. 90.0°-90.0°, MPTA 90.0°-90.0° vs. 90.0°-90.0°, tibial posterior slope - 10° to 10° vs. - 1° to 10°). No differences were seen for other angles measured. Comparing both systems, total number of outliers was higher using standard (8%) vs. single-use instruments (4.3%). CONCLUSION This study shows a high accuracy of CT-based patient-specific instrumentation concerning postoperative achieved knee angles and mechanical leg axes. Single-use instruments showed a similar accuracy. LEVEL OF EVIDENCE III.
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A Randomized Trial Investigating the Cost-Utility of Patient-Specific Instrumentation in Total Knee Arthroplasty in an Obese Population. J Arthroplasty 2021; 36:3078-3088. [PMID: 34053752 DOI: 10.1016/j.arth.2021.04.029] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/08/2021] [Revised: 04/22/2021] [Accepted: 04/23/2021] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) with the goal of increased accuracy of component positioning by custom fitting cutting guides to the patient's bony anatomy. A criticism of this technology is the associated cost. The purpose of this randomized controlled trial was to determine the cost-utility of PSI compared with standard of care (SOC) instrumentation for TKA in an obese population. METHODS Patients with body mass index greater than 30 with osteoarthritis and undergoing primary TKA were randomized to SOC or PSI. Patients completed a health care resource use diary and the EuroQol-5D at three, six, nine, and 12 months and the Western Ontario and McMaster Universities Osteoarthritis Index at three and 12 months postsurgery. We performed cost-utility and cost-effectiveness analyses from public health care payer and societal perspectives. RESULTS One hundred seventy-three patients were included in the analysis with 86 patients randomized to PSI and 87 to SOC. PSI was dominated (more costly and less effective) by SOC from a health care payer perspective. From a societal perspective, an incremental cost-utility ratio was calculated at $11,230.00 per quality-adjusted life year gained, which is cost-effective at a willingness to pay threshold of $50,000. Net benefit analyses found PSI was not significantly cost-effective at any willingness to pay value from either perspective. CONCLUSION Our results suggest that widespread adoption of PSI may not be economically attractive or clinically indicated. Future considerations are to compare long-term clinical outcomes and radiographic alignment between the groups.
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13
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Török L, Jávor P, Hartmann P, Bánki L, Varga E. Should we abandon the patient-specific instrumentation ship in total knee arthroplasty? Not quite yet! BMC Musculoskelet Disord 2021; 22:730. [PMID: 34429099 PMCID: PMC8386088 DOI: 10.1186/s12891-021-04581-2] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Accepted: 08/04/2021] [Indexed: 11/10/2022] Open
Abstract
Patient-specific Instrumentation (PSI) is an innovative technique aiding the precise implementation of the preoperative plan during total knee arthroplasty (TKA) by using patient-specific guides and cutting blocks. Despite of the theoretical advantages, studies have reported contradictory results, thus there is no consensus regarding the overall effectiveness of PSI. Through the critical assessment of a meta-analysis published lately, this correspondence aims to highlight the complexity of comparing the efficacy of PSI to standard instrumentation (SI). The accuracy of component alignment, patient-reported outcome measures (PROMs), surgery time, blood loss, transfusion rate, and postoperative complications are commonly used outcomes for investigating the efficacy of PSI-aided TKA. By assessing component alignment, the expertise of the surgeon(s) should be taken into consideration, since PSI may not provide benefits for expert surgeons but might improve accuracy and patient safety during the learning curve of novice surgeons. With respect to PROMs and postoperative complications, PSI may not improve short-term results; however, long-term follow up data is missing. Regarding transfusion rates, favorable trends can be observed, but further studies utilizing recent data are needed for a clear conclusion. When assessing surgery time, we suggest focusing on operating room turnover instead of procedure time.
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Affiliation(s)
- László Török
- Department of Traumatology, University of Szeged, Semmelweis u. 6, Szeged, 6725, Hungary.,Department of Sports Medicine, University of Szeged, Tisza Lajos Krt. 107, Szeged, 6725, Hungary
| | - Péter Jávor
- Department of Traumatology, University of Szeged, Semmelweis u. 6, Szeged, 6725, Hungary
| | - Petra Hartmann
- Department of Traumatology, University of Szeged, Semmelweis u. 6, Szeged, 6725, Hungary
| | - László Bánki
- Department of Traumatology, University of Szeged, Semmelweis u. 6, Szeged, 6725, Hungary
| | - Endre Varga
- Department of Traumatology, University of Szeged, Semmelweis u. 6, Szeged, 6725, Hungary.
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Deng T, Liu T, Lei Q, Cai L, Chen S. Patient-specific instrumentation combined with a new tool for gap balancing is useful in total knee replacement: a 3-year follow-up of a retrospective study. J Orthop Surg Res 2021; 16:309. [PMID: 33980282 PMCID: PMC8114523 DOI: 10.1186/s13018-021-02467-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2020] [Accepted: 05/06/2021] [Indexed: 11/10/2022] Open
Abstract
Objective The purpose of this study was to determine whether the gap-balancing technique with patient-specific instrumentation (PSI) and a new balancing device in total knee arthroplasty (TKA) can improve knee function to a greater extent than can the measured resection technique. Materials and methods Data from 150 patients who underwent TKA from August 2014 to June 2016 were studied retrospectively. The gap-balancing technique assisted by PSI and the new balancing device was used in 80 patients (82 knees), and the measured resection technique was used in 70 patients (70 knees). The surgical, imaging, and knee function data were compared. Results The gap-balancing technique assisted by PSI and the new balancing device was found to be feasible in all operated knees and reliable. In total, 150 patients (152 knees) of ages ranging from 52 to 78 years (mean 67 years) underwent TKA during the study period. The follow-up period ranged from 35 to 52 months (mean 45 months). Only one patient, who was included in the gap-balancing group, underwent a revision surgery at 2 years postoperatively due to infection. There were no differences in the incidence of anterior knee pain between the two groups. The mean flexion angle, KSS scores, and VAS scores did not significantly differ between the measured resection group and gap-balancing group at 12 weeks or 36 weeks postoperatively. The average joint line displacement was 1.3 ± 1.1 mm (range 0–3) proximally in the GB (gap-balancing) group and 1.2 ± 1.4 mm in the MR (measured-resection) group. No outliers >5 mm in either group were recorded. The mean leg axis deviation from the neutral mechanical axis was 1.8°±1.5° varus (range 0°–3°varus) versus the neutral mechanical axis in the GB group and 1.4°±1.2°(range 0°–3°)in the MR group. No outliers with >3° deviation in either group were recorded. Conclusions The gap-balancing technique performed with the new balancing device and PSI can yield accurate femoral component alignment as well as outcomes similar to those of measured resection at 3 years. The new balancing device can be taken into consideration by surgeons who prefer performing the gap-balancing technique with PSI.
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Affiliation(s)
- Ting Deng
- Department of Orthopaedics, The Third Hospital of Changsha, Changsha, China
| | - Tangyou Liu
- Department of Orthopaedics, The Third Hospital of Changsha, Changsha, China
| | - Qing Lei
- Department of Orthopaedics, The Third Hospital of Changsha, Changsha, China.
| | - Lihong Cai
- Department of Radiology, The Third Hospital of Changsha, Changsha, China
| | - Song Chen
- Department of Orthopaedics, The Third Hospital of Changsha, Changsha, China
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Three-dimensional Printing in Orthopaedic Surgery: Current Applications and Future Developments. JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS GLOBAL RESEARCH AND REVIEWS 2021; 5:e20.00230-11. [PMID: 33877073 PMCID: PMC8059996 DOI: 10.5435/jaaosglobal-d-20-00230] [Citation(s) in RCA: 40] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/04/2020] [Accepted: 03/09/2021] [Indexed: 12/27/2022]
Abstract
Three-dimensional (3D) printing is an exciting form of manufacturing technology that has transformed the way we can treat various medical pathologies. Also known as additive manufacturing, 3D printing fuses materials together in a layer-by-layer fashion to construct a final 3D product. This technology allows flexibility in the design process and enables efficient production of both off-the-shelf and personalized medical products that accommodate patient needs better than traditional manufacturing processes. In the field of orthopaedic surgery, 3D printing implants and instrumentation can be used to address a variety of pathologies that would otherwise be challenging to manage with products made from traditional subtractive manufacturing. Furthermore, 3D bioprinting has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform how we treat patients with debilitating musculoskeletal injuries. Although costs can be high, as technology advances, the economics of 3D printing will improve, especially as the benefits of this technology have clearly been demonstrated in both orthopaedic surgery and medicine as a whole. This review outlines the basics of 3D printing technology and its current applications in orthopaedic surgery and ends with a brief summary of 3D bioprinting and its potential future impact.
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Abstract
Because value in healthcare has shifted to a measurement of quality relative to the cost, a greater emphasis exists on improving clinical and functional outcomes and patient satisfaction. Despite advances in implant design, surgical technique, and postoperative rehabilitation, multiple studies demonstrate that nearly 20% of patients remain dissatisfied with their overall outcomes after primary total knee arthroplasty (TKA). Because implant positioning, alignment, and equal soft-tissue balance are critical for a successful TKA, malalignment in the coronal, sagittal, and rotational planes continue to increase failure rates and cause poor clinical outcomes. Robotic-assisted TKA has gained momentum within the past 10 years to better control surgical variables by mitigating technical errors caused by insecure cutting guides and imprecise bone cuts. Contemporary robotic platforms have evolved along with our ability to collect high-quality patient-reported outcome measures data, and this combination is proving the clinical effectiveness. This comprehensive review investigates the advent of robotic-assisted TKA including advantages, disadvantages, historical, and commercially available newer generation systems, clinical outcomes, and cost analysis to better understand the potential added value of this technology.
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Bugbee WD, Kolessar DJ, Davidson JS, Gibbon AJ, Lesko JP, Cosgrove KD. Single Use Instruments for Implanting a Contemporary Total Knee Arthroplasty System Are Accurate, Efficient, and Safe. J Arthroplasty 2021; 36:135-139.e2. [PMID: 32800434 DOI: 10.1016/j.arth.2020.07.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2020] [Revised: 06/03/2020] [Accepted: 07/11/2020] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Single use instruments (SUI) is a potential mechanism to improve efficiency and reduce cost in total knee arthroplasty (TKA). New technology requires patient safety and surgical accuracy. A multi-center study of SUI vs reusable mechanical instrumentation (RUI) for a TKA system compared implant placement accuracy and operating room (OR) efficiency. METHODS Four surgeons implanted 88 primary TKAs, N = 44 RUI and N = 44 SUI. Accuracy was measured radiographically at 3 months. The primary endpoint was non-inferiority of absolute value of mechanical axis alignment. Radiographic endpoints, OR times, and adverse events were also evaluated. RESULTS Seventy-five subjects completed the study (41 SUI/34 RUI). The primary endpoint non-inferiority of SUI vs RUI was met, with no significant difference between SUI and RUI in most radiographic parameters (distal femoral varus-valgus, proximal tibial varus-valgus, tibial slope, or subjects within 3° of target); there was a slight difference in femoral component flexion angle (P = .015). SUI and RUI mean (SD) OR set-up times were 18.8 (10.03) and 26.7 (6.93) (P <.001), and surgical times (first incision to last stitch) were 64.6 (16.95) and 60.5 (19.01) (P = .295), respectively. Differences in OR clean-down and anesthesia were not significant. There were no revisions, and there was no significant difference in the number of reported adverse events. CONCLUSION SUI resulted in similar accuracy of implant placement to RUI with decreased OR set-up time and no increase in adverse events. These results support the safety and efficacy of SUI for performing TKA. Further analysis of potential economic and technical advantages is warranted.
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Affiliation(s)
| | - David J Kolessar
- Department of Orthopaedic Surgery, Geisinger Musculoskeletal Institute, Wilkes-Barre, PA
| | - John S Davidson
- Bone and Joint Centre, Spire Liverpool Hospital, Liverpool, United Kingdom
| | | | - James P Lesko
- Clinical Research, DePuy Synthes Joint Reconstruction, Inc., Warsaw, IN
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Fucentese SF, Koch PP. A novel augmented reality-based surgical guidance system for total knee arthroplasty. Arch Orthop Trauma Surg 2021; 141:2227-2233. [PMID: 34698930 PMCID: PMC8595230 DOI: 10.1007/s00402-021-04204-4] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2021] [Accepted: 09/29/2021] [Indexed: 11/07/2022]
Abstract
INTRODUCTION Many of the functional complications that arise after total knee arthroplasty (TKA) are caused by a non-optimal balance of the knee after surgery. Over the past 20 years, technology has been used in the Operating Room (OR) to help improve precision and balance. The results of Computer-Assisted Surgery (CAS) and robotic systems show improved accuracy regarding implant positioning but a relatively small improvement in patient-reported outcomes and implant survival compared to conventional TKA. Recently, Augmented Reality (AR) has been proposed as a technology that could improve accuracy in orthopaedic surgery, providing a more efficient and cost-effective solution. MATERIALS AND METHODS This article describes a novel AR-based surgical guidance system that measures intra-operatively the effect of prosthesis alignment and positioning on soft tissue balance. The system is integrated in a pair of smart glasses and two small sensors and displays surgical targets directly in the field of view of the surgeon. RESULTS The system has been used in a limited number of cases. While the preliminary experience has been positive, clinical research is ongoing to confirm to confirm the performance of the system and the impact on clinical outcomes. CONCLUSION Augmented Reality can be a valuable tool to improve accuracy in TKA. The use of smart glasses and integrated sensors improves the efficiency of the procedure, particularly when coupled with single-use instrumentation. A novel protocol for soft tissue assessment allows for a 3-dimensional evaluation of the ligaments and a better measurement of the effect of tibial rotation.
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Affiliation(s)
- Sandro F. Fucentese
- grid.7400.30000 0004 1937 0650University Hospital Balgrist, University of Zurich, Forchstrasse 340, 8008 Zurich, Switzerland
| | - Peter P. Koch
- grid.452288.10000 0001 0697 1703Department of Orthopaedic Surgery and Traumatology, Kantonsspital Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland
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Schömig F, Perka C, Pumberger M, Ascherl R. Implant contamination as a cause of surgical site infection in spinal surgery: are single-use implants a reasonable solution? - a systematic review. BMC Musculoskelet Disord 2020; 21:634. [PMID: 32977778 PMCID: PMC7519515 DOI: 10.1186/s12891-020-03653-z] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/22/2020] [Accepted: 09/16/2020] [Indexed: 01/03/2023] Open
Abstract
Background In spine surgery, surgical site infection (SSI) is one of the main perioperative complications and is associated with a higher patient morbidity and longer patient hospitalization. Most factors associated with SSI are connected with asepsis during the surgical procedure and thus with contamination of implants and instruments used which can be caused by pre- and intraoperative factors. In this systematic review we evaluate the current literature on these causes and discuss possible solutions to avoid implant and instrument contamination. Methods A systematic literature search of PubMed addressing implant, instrument and tray contamination in orthopaedic and spinal surgery from 2001 to 2019 was conducted following the PRISMA guidelines. All studies regarding implant and instrument contamination in orthopaedic surgery published in English language were included. Results Thirty-five studies were eligible for inclusion and were divided into pre- and intraoperative causes for implant and instrument contamination. Multiple studies showed that reprocessing of medical devices for surgery may be insufficient and lead to surgical site contamination. Regarding intraoperative causes, contamination of gloves and gowns as well as contamination via air are the most striking factors contributing to microbial contamination. Conclusions Our systematic literature review shows that multiple factors can lead to instrument or implant contamination. Intraoperative causes of contamination can be avoided by implementing behavior such as changing gloves right before handling an implant and reducing the instruments’ intraoperative exposure to air. In avoidance of preoperative contamination, there still is a lack of convincing evidence for the use of single-use implants in orthopaedic surgery.
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Affiliation(s)
- Friederike Schömig
- Center for Musculoskeletal Surgery, Charité - University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany.
| | - Carsten Perka
- Center for Musculoskeletal Surgery, Charité - University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany
| | - Matthias Pumberger
- Center for Musculoskeletal Surgery, Charité - University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany
| | - Rudolf Ascherl
- Center for Musculoskeletal Surgery, Charité - University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany
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Chen PC, Chang CC, Chen HT, Lin CY, Ho TY, Chen YJ, Tsai CH, Tsou HK, Lin CS, Chen YW, Hsu HC. The Accuracy of 3D Printing Assistance in the Spinal Deformity Surgery. BIOMED RESEARCH INTERNATIONAL 2019; 2019:7196528. [PMID: 31828123 PMCID: PMC6885147 DOI: 10.1155/2019/7196528] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/24/2019] [Revised: 07/21/2019] [Accepted: 10/05/2019] [Indexed: 12/25/2022]
Abstract
BACKGROUND The pedicle screw is one of the main tools used in spinal deformity correction surgery. Robotic and navigated surgeries are usually used, and they provide superior accuracy in pedicle screw placement than free-hand and fluoroscopy-guided techniques. However, their high cost and space limitation are problematic. We provide a new solution using 3D printing technology to facilitate spinal deformity surgery. METHODS A workflow was developed to assist spinal deformity surgery using 3D printing technology. The trajectory and profile of pedicle screws were determined on the image system by the surgical team. The engineering team designed drill templates based on the bony surface anatomy and the trajectory of pedicle screws. Their effectiveness and safety were evaluated during a preoperative simulation surgery. The surgery consisted in making a pilot hole through the drill template on a computed tomography- (CT-) based, full-scale 3D spine model for every planned segment. Somatosensory evoke potential (SSEP) and motor evoke potential (MEP) were used for intraoperative neurophysiological monitoring. Postoperative CT was obtained 6 months after the correction surgery to confirm the screw accuracy. RESULTS From July 2015 to November 2016, we performed 10 spinal deformity surgeries with 3D printing technology assistance. In total, 173 pedicle screws were implanted using drill templates. No notable change in SSEP and MEP or neurologic deficit was noted. Based on postoperative CT scans, the acceptable rate was 97.1% (168/173). We recorded twelve pedicle screws with medial breach, six with lateral breach, and five with inferior breach. Medial breach (12/23) was the main type of penetration. Lateral breach occurred mostly in the concave side (5/6). Most penetrations occurred above the T8 level (69.6%, 16/23). CONCLUSION 3D printing technology provides an effective alternative for spinal deformity surgery when expensive medical equipment, such as intraoperative navigation and robotic systems, is unavailable.
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Affiliation(s)
- Po-Chen Chen
- Section of Orthopaedic Surgery, Department of Surgery, Ministry of Health and Welfare, Changhua Hospital, Changhua, Taiwan
| | - Chien-Chun Chang
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
- Ph.D. Degree Program of Biomedical Science and Engineering, National Chiao Tung University, Hsinchu, Taiwan
| | - Hsien-Te Chen
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
- Department of Sports Medicine, College of Health Care, China Medical University, Taichung, Taiwan
| | - Chia-Yu Lin
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
| | - Tsung-Yu Ho
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
| | - Yen-Jen Chen
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
- School of Medicine, China Medical University, Taichung, Taiwan
| | - Chun-Hao Tsai
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
- School of Medicine, China Medical University, Taichung, Taiwan
| | - Hsi-Kai Tsou
- Functional Neurosurgery Division, Neurological Institute, Taichung Veterans General Hospital, Taichung, Taiwan
- Department of Rehabilitation, Jen-Teh Junior College of Medicine, Nursing and Management, Miaoli County, Taiwan
| | - Chih-Sheng Lin
- Ph.D. Degree Program of Biomedical Science and Engineering, National Chiao Tung University, Hsinchu, Taiwan
- Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan
| | - Yi-Wen Chen
- Graduate Institute of Biomedical Sciences, China Medical University, Taichung, Taiwan
- 3D Printing Medical Research Institute, Asia University, Taichung, Taiwan
| | - Horng-Chaung Hsu
- Department of Orthopaedic Surgery, China Medical University Hospital, China Medical University, Taichung, Taiwan
- School of Medicine, China Medical University, Taichung, Taiwan
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