Mechanical Analysis of a Novel 3D-printed External Fixator Design Versus Industry-standard External Fixators.

INTRODUCTION: External fixation is a critical component of orthopaedic fracture management and is used for various conditions, including trauma and pediatric orthopaedics. However, the availability and high cost of external fixation devices are a concern, especially in rural and developing countries. 3D printing technology has shown promise in reducing manufacturing costs and improving accessibility to external fixation devices. The purpose of this study was to evaluate the mechanical properties of a fully 3D-printed desktop external fixation device and compare the results with the mechanical properties of commonly used, clinically available external fixators. METHODS: A fully 3D printable external fixator was designed and printed in polylactic acid at two infill densities, 20% and 100%. The mechanical properties of the 3D-printed external fixators and several commercially available fixators were tested according to applicable sections of the American Society for Testing and Materials F1541 standard protocol in axial, medial-lateral, and anterior-posterior orientations. The primary outcomes measured included failure load, safe load, rigidity, and yield load. The mean differences between experimental and control groups were calculated using one-way analysis of variance and Tukey tests. RESULTS: The 20% infill 3D-printed construct showed poor performance compared with commercially available external fixators in all testing conditions and across most variables. The 100% infill 3D-printed construct was comparable with or superior to all commercially available devices in most testing conditions. The cost for printing a single 3D-printed 100% infill external fixator was $14.49 (United States Dollar). DISCUSSION: This study demonstrates that a low-cost desktop 3D printer can create an entirely 3D-printed external fixator that resists clinically relevant forces similar to medical-grade industry-standard external fixators. Therefore, there is potential for customizable and low-cost external fixators to be manufactured with desktop 3D printing for use in remote areas and other resource-constrained environments for fracture care.

THE EFFECT OF TIME AND SEX ON POST-ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PSYCHOLOGICAL PATIENT REPORTED OUTCOME MEASURE SCORES.

CONTEXT: Low scores on psychological patient reported outcomes measures (PROMs), including the anterior cruciate ligament-return to sport after injury (ACL-RSI) and injury-psychological readiness to return to sport (I-PRRS), after anterior cruciate ligament (ACL) reconstruction (ACLR) have been associated with a maladaptive psychological response to injury and poor prognosis. OBJECTIVE: The purpose of this study was to assess the effect of time post-ACLR and sex on ACL-RSI and I-PRRS scores and generate normative reference curves. It was hypothesized that males would demonstrate higher ACL-RSI and I-PRRS scores than females in the first 1-year post-ACLR. DESIGN: Case series. SETTING: Outpatient sports medicine and orthopedic clinic. PATIENTS: 507 patients post-primary ACLR 12-to-30-years-old with 796 ACL-RSI or I-PRRS scores one or more times between 0- and 1-year post-ACLR (age at ACLR: 17.9 ± 3.0 y). MAIN OUTCOME MEASURES: An honest broker provided anonymous data from our institution's knee injury clinical database. Generalized additive models for location, scale, and shape and generalized least squares analyses were used to assess the effect of time post-ACLR and sex on ACL-RSI and I-PRRS scores. RESULTS: ACL-RSI and I-PRRS scores increased over time post-ACLR, and males had higher scores compared to females up until approximately five months post-ACLR with scores converging thereafter. CONCLUSIONS: Males report higher ACL-RSI and I-PRRS scores compared to females in the initial stages of rehabilitation, but scores converge between sexes at times associated with return to play following ACLR. Normative reference curves can be used to objectively appraise patients' ACL-RSI and I-PRRS scores at any time point post-ACLR. This may lead to timely identification of patients with scores or changes in scores over time post-ACLR associated with a maladaptive psychological response to injury and a poor prognosis and optimized ACLR outcomes.

Clinical Practice Update: Achilles Tendon Rupture.

Achilles tendon rupture is a common injury. It most often occurs in middle aged men who participate in recreational sports. The injury classically presents with a loud popping noise and immediate pain and weakness of the lower extremity during actions such as jumping or running. The diagnosis is made clinically, but an MRI is often obtained for confirmation of rupture and to aid in surgical planning. Treatment is either operative, with open or minimally invasive approaches, or non-operative, with functional bracing or plaster casting. Surgical treatment was preferred for much of the 20th century, but non-operative treatment has gained significant favor in the past 15 years as new evidence has demonstrated similar long-term outcomes to surgery. Neither treatment option is currently considered superior to the other in all cases. Surgery is associated with a risk for surgical complications and is, therefore, often a poor option for the elderly and those with significant comorbidities. Non-operative management is associated with an increased risk for re-injury which is often undesirable for young and highly active patients. Ultimately, the goals and priorities of each individual patient should guide the decision of which treatment option to pursue.

3D Printed Orthopaedic External Fixation Devices: A Systematic Review.

BACKGROUND: External fixators are complex, expensive orthopaedic devices used to stabilize high-energy and complex fractures of the extremities. Although the technology has advanced dramatically over the last several decades, the mechanical goals for fracture stabilization of these devices have remained unchanged. Three-dimensional (3D) printing technology has the potential to advance the practice and access to external fixation devices in orthopaedics. This publication aims to systematically review and synthesize the current literature on 3D printed external fixation devices for managing orthopaedic trauma fractures. METHODS: The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocols were followed for this manuscript with minor exceptions. PubMed, Embase, Cochrane Review, Google Scholar, and Scopus online databases were systematically searched. Two independent reviewers screened the search results based on predetermined inclusion and exclusion criteria related to 3D printing and external fixation of fractures. RESULTS: Nine studies met the inclusion criteria. These included one mechanical testing study, two computational simulation studies, three feasibility studies, and three clinical case studies. Fixator designs and materials varied significantly between authors. Mechanical testing revealed similar strength to traditional metal external fixators. Across all clinical studies, five patients underwent definitive treatment with 3D printed external fixators. They all had satisfactory reduction and healing with no reported complications. CONCLUSIONS: The current literature on this topic is heterogeneous, with highly variable external fixator designs and testing techniques. A small and limited number of studies in the scientific literature have analyzed the use of 3D printing in this area of orthopaedic surgery. 3D printed external fixation design advancements have yielded promising results in several small clinical case studies. However, additional studies on a larger scale with standardized testing and reporting techniques are needed.

Design and Development of a Novel 3-D Printed External Fixation Device for Fracture Stabilization.

BACKGROUND: An external fixator is an orthopaedic device used to stabilize long bone fractures after high energy trauma. These devices are external to the body and fixed to metal pins going into non-injured areas of bone. They serve a mechanical function to maintain length, prevent bending, and resist torque forces about the fracture area. The purpose of this manuscript is to describe a design and prototyping process creating a low-cost entirely 3-D printed external fixator for fracture stabilization of extremity fractures. The secondary objective of this manuscript is to facilitate future advancements, modifications, and innovations in this area of 3-D printing in medicine. METHODS: This manuscript describes the computer aided design process using desktop fused deposition modeling to create a 3-D printed external fixator system designed for fracture stabilization. The device was created using the orthopaedic goals for fracture stabilization with external fixation. However, special modifications and considerations had to be accounted for given the limitations of desktop fused deposition modeling and 3-D printing with plastic polymers. RESULTS: The presented device accomplishes the goals of creating a construct that can be attached to 5.0 mm metal pins, allows for modularity in placement orientations, and facilitates adjustable lengths for fracture care. Furthermore, the device provides length stability, prevention of bending, and resists torque forces. The device can be printed on a desktop 3-D printer using standard low-cost polylactic acid filament. The print time is less than two days and can be completed on one print bed platform. CONCLUSIONS: The presented device is a potential alternative for fracture stabilization. The concept of a desktop 3-D printed external fixator design and method of production allows for numerous diverse applications. This includes assisting areas with remote or limited access to advanced medical care and large-scale natural disasters or global conflicts where large volumes of fractures exceed the local medical supply chain capabilities. The presented device creates a foundation for future devices and innovations in this fracture care space. Further research is needed on mechanical testing and clinical outcomes with this design and initiative in fracture care before clinical application.

Three-dimensional Printing Technology in Orthopaedics.

Three-dimensional (3-D) printing technology is affecting how orthopaedic surgeries are planned and executed. Like many innovations, 3-D printers are becoming smaller, more affordable, and more accessible. Free access to open-source 3-D imaging software has also made clinical implementation of this technology widely feasible. Within the last decade, 3-D printing advancements have improved the way orthopaedic surgeons can approach both common and complex cases. Advanced imaging studies can be used to create musculoskeletal models, which can then be used to create custom orthopaedic guides and instruments. Similarly, 3-D printing is being applied to improve the field of biologic therapies in orthopaedics. Application of 3-D printing technology has been associated with important improvements in education, preoperative planning, surgical care, and patient-specific devices and treatments. Improvements in cost-effectiveness, access, and usability of 3-D printing technology have made it possible for orthopaedic surgeons to use this powerful tool using desktop 3-D printers in their clinic or office. The types of printers and materials available to print are constantly expanding, but many of the basic 3-D printing principles persist throughout these advances in the field. A clear understanding of this technology is important to the clinical implementation of 3-D printing for current and future practice of orthopaedic care.

The impact of volume reduction on early and long-term outcomes in surgical ventricular restoration for severe heart failure.

BACKGROUND: Recent published results suggest no additive benefit to surgical ventricular restoration (SVR) when combined with coronary artery bypass grafting. However, there may still be a subgroup of patients with severe heart failure who can benefit from this procedure. We reviewed our institutional experience with SVR to determine early and late outcomes based on volume reduction. METHODS: We retrospectively reviewed our SVR patients (January 2002 to April 2008) with follow-up to March 2009. Baseline comorbidities, operative data, and postoperative outcomes were assessed by chart review, phone calls, and mailings. Survival was modeled using the Kaplan-Meier method. Cardiac magnetic resonance imaging, myocardial perfusion scans, and echocardiography assessed cardiac function, candidacy for SVR, and volume reduction. RESULTS: We reviewed 87 consecutive SVR patients (69 men). Mean age at operation was 61.1 years. Preoperatively, all patients had congestive heart failure, with 80 (92%) at New York Heart Association III/IV. All patients underwent preoperative viability studies. Three-vessel occlusion exceeding 50% was present in 69 (79%). After SVR, ejection fraction improved from 0.236 to 0.332 (p<0.001). Preoperative and postoperative magnetic resonance imaging in 26 patients (30.0%) showed a 30.8% reduction in left ventricular end systolic volume index. At follow-up, 51 of 66 (77%) improved to New York Heart Association I/II. One intraoperative death occurred. Preoperative left ventricular end systolic volume index of 80 to 120 was associated with improved survival (73% at 3 years). CONCLUSIONS: SVR is a surgical option for appropriately selected patients with severe congestive heart failure. In these high-risk patients, SVR successfully increased ejection fraction and decreased symptoms. A left ventricular end systolic volume index of 80 to 120 may be the ideal range for SVR procedures.