Custom Implants Research Articles

Personalized 3D-printed cranial implants for complex cranioplasty using open-source software.

Cranioplasty is a routine neurosurgery treatment used to correct cranial vault abnormalities. Utilization of 3D printing technology in the field of cranioplasty involving the reconstruction of cranial defects emerged as an advanced possibility of anatomical reshaping. The transformative impact of patient-specific 3D printed implants, focuses on their remarkable accuracy, customization capabilities, and enhanced biocompatibility. The precise adaptation of implants to patient-specific anatomies, even in complex cases we presented, result in improved aesthetic outcomes and reduced surgical complications. The ability to create highly customized implants addresses the functional aspects of cranial defects and considers the psychological impact on patients. By combining technological innovation with personalized patient care, 3D printed cranioplasty emerges as a transformative avenue in cranial reconstruction, ultimately redefining the standards of success in neurosurgery. 3D printing allows an excellent cranioplasty cosmesis achieved at a reasonable price without sacrificing patient outcomes. Wider implementation of this strategy can lead to significant healthcare cost savings.

Virtual Modeling in Gender-Affirming Facial Masculinization Surgery.

The increase in access to facial gender-affirming surgery has resulted in a rise in facial feminization surgeries for transfeminine and gender non-binary populations. However, refined execution of facial masculinization is challenged by the lack of defined measurements for facial augmentation, the lack of long-term predictability in autologous bone grafting in augmentation procedures, and the lack of precision in traditional facial augmentation procedures with generic alloplastic implants. In this work, we describe an innovation in facial masculinization surgery using modern reconstructive craniofacial surgical techniques with preoperative virtual modeling and the fabrication of three-dimensionally printed, patient-specific custom implants.

Metamaterials offer promising new functionalities for orthopedic implants

Unique properties exhibited by composite materials could lead to stronger, cheaper, more customizable implants.

Role of 3D printed customized implants in periarticular fractures: a narrative review

“3D printing” is a common term used for a number of technologies which operate on the principle of converting a computer-generated 3D image into a physical model. Advantage of 3D printed parts is that they can assume complex shape, with solid and porous components that can be combined to provide the best combination of strength and performances and can help visualize the complex fractures which are difficult to apprehend with conventional imaging. Presently, the primary applications for 3D printing are the production of anatomical models for planning and surgery simulation, patient-specific instruments and custom-made prosthesis which have transformed how orthopedic problems are addressed now. This review aims to describe the utility and future directives into the application of this technology in orthopedics.

EFFECT OF LAB PROCEDURES AND ULTRASONIC-BATH CLEANING ON CUSTOMIZED IMPLANT ABUTMENT POLLUTION: AN IN VITRO STUDY.

To validate the effectiveness of a simplified ultrasonic cleaning protocol to clean customized abutments, and to investigate the percentage of pollutants on customized abutments provided by the implant company and the additional effect of dental laboratory manipulations. A total of 24 customized abutments were divided in two groups, 12 returning from the implant company and 12 others returning from the dental laboratory. In each group, there were 6 zirconia (Zr02) abutments and 6 .tanium (Ti) abutments. For each condition, half of the samples were cleaned with the experimental protocol, and the others were left as delivered by the company. The two-step cleaning protocol consisted of mechanical treatment with a sterile compress soaked in a detergent over the transgingival part of the abutment, followed by three successive ultrasound baths for two minutes/bath. The presence of pollutants was quantified using scanning electron microscopy. The suggested cleaning method allowed to significantly decrease the quantity of pollutants (P = .0006). The abutments returning from the dental laboratory were significantly more polluted than those coming directly from the implant company (P = .0043). The cleaning effect was highly significant in both groups (P < .0001). The quantity of pollutants before cleaning were similar in the titanium and in the zirconia groups and the cleaning effect was highly significant in both groups (P = .0009). The cleaning protocol tested was successful on the customized abutments from each group.

Polyether Ether Ketone (PEEK) Implants and the Manufacturer and User Facility Device Experience (MAUDE) Database: An Updated Review of Adverse Events and Complications.

Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice. A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively. Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications. Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.

Comparison between prefabricated and customized prostheses of the temporomandibular joint: a systematic review with meta-analysis

Introduction: The TMJ can be affected by end-stage pathologies, such as arthritic disease, trauma, and ankylosis. The main debilitating symptoms result in limited mouth opening and pain. The TMJ prosthesis is indicated for a disease that results in anatomical modification and aims to restore joint function with pain relief. There are two types of prefabricated (stock) and custom computer-aided design/computer-aided manufacturing (CAD/CAM) system devices. Objective: It was to demonstrate through a systematic review whether the customized temporomandibular joint prosthesis has more advantages than the prefabricated prosthesis. Methods: The research was carried out from June to September 2022, using scientific articles from 2013 to 2022. The quality of the studies was based on the GRADE instrument and the risk of bias by the instrument Cochrane (Funnel Plot). Results: It was found 158 studies that underwent eligibility analysis. Conclusion: In general, both TMJ and custom implants work well. However, the added advantages of customized prostheses, along with increasing access to digital technology, are likely to result in customized devices dominating the market in total ATM replacement systems.

Improving personalized medical implant design: An innovative and automated method leveraging implicit modeling

Advancements in manufacturing technologies have made the design and surgical applications of personalized implants increasingly popular and widespread. This study presents a fast, parametric, and automatic workflow for creating customized implants to be used in the surgical treatment of humerus bone traumas. The workflow operates on various humerus fractures, such as “Butterfly Fragment” fractures, taking into account patient-specific bone geometries and areas where screws will be applied. The workflow is carried out using implicit modelling and nTopology software. Initially, a replica of the “Butterfly Fragment” fracture is created for the study, and the damaged bone tissue is removed. Subsequently, a filler structure connecting the two main fragments is obtained using a porous structure. The workflow continues with the identification of areas where screws will be applied around the bone trauma and the selection of the surface where the implant will be created. Using selected points on the surface mesh and single-dimensional beams guided by these points, the external geometry and screw holes of the implant are shaped. The workflow is completed by offsetting certain structures created in intermediate steps and applying surface treatments to obtain the final shape and thickness of the implant, which is compatible with the bone structure. At the end of the process, the workflow is converted into a single function block, which can be shared for use by an implant designer. This enables the widespread application of personalized implant designs. The workflow accelerates the design process of the implant, providing implicit data suitable for production using additive manufacturing. This study offers a preparatory process for the rapid design and production of customized implants for patients. Future research may include comparisons of CAD design and implicit modelling methods, time studies, process modifications, optimizations, and investigations related to additive manufacturing printers. This study contributes to shortening the time until the application of surgical treatment methods by accelerating the design and production process of customized implants.

Clinical and radiologic outcomes of Lima ProMade custom 3D-printed glenoid components in primary and revision reverse total shoulder arthroplasty with severe glenoid bone loss: a minimum 2-year follow-up.

The purpose of this study is to report the clinical and radiologic outcomes of patients undergoing primary or revision reverse total shoulder arthroplasty using custom 3D-printed components to manage severe glenoid bone loss with a minimum of 2-year follow-up. Following ethical approval, patients were identified and invited to participate. Inclusion criteria were (1) severe glenoid bone loss necessitating the need for custom implants and (2) patients with definitive glenoid and humeral components implanted more than 2 years prior. Included patients underwent clinical assessment using the Oxford Shoulder Score (OSS), Constant-Murley score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and the quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH). Radiographic assessment included anteroposterior and axial projections. Patients were invited to attend a computed tomography (CT) scan to confirm osseointegration. Statistical analysis used descriptive statistics (mean and standard deviation [SD]) and paired t test for parametric data. Eleven patients declined to participate. Five patients were deceased prior to study commencement, leaving 42 remaining patients in this analysis. Three patients had revision surgery before the 2-year follow-up; of these, 2 retained their custom glenoid components. Mean follow-up was 31.6 months from surgery (range 24-52 months). All 4 scores improved: OSS from a mean 15 (SD8.4) to 36 (SD12) (P<.001), Constant-Murley score from a mean 15 (SD11.2) to 52 (SD20.1) (P<.001), QuickDASH from a mean 70 (SD21) to 31 (SD24.8) (P=.004), and the ASES score from a mean 22 (SD17.8) to 71 (SD23.3) (P=.007). Radiologic evaluation demonstrated good osseointegration in all but 1 included patient. The utility of custom 3D-printed components for managing severe glenoid bone loss in primary and revision reverse total shoulder arthroplasty yields significant clinical improvements in this complex cohort. Large complex glenoid bone defects can be managed successfully with custom 3D-printed glenoid components.

Additively manufactured medical bone screws: an initial study to investigate the impact of lattice-based Voronoi structure on implant primary stability

PurposeThe present study investigates the mechanical properties of three types of Ti6Al4V ELI bone screws realized using the laser powder bed fusion (LPBF) process: a fully threaded screw and two groups containing differently arranged sectors made of lattice-based Voronoi (LBV) structure in a longitudinal and transversal position, respectively. This study aims to explore the potentialities related to the introduction of LBV structure and assess its impact on the implant’s primary stability and mechanical performance.Design/methodology/approachThe optimized bone screw designs were realized using the LPBF process. The quality and integrity of the specimens were assessed by scanning electron microscopy and micro-computed tomography. Primary stability was experimentally verified by the insertion and removal of the screws in standard polyurethane foam blocks. Finally, torsional tests were carried out to compare and assess the mechanical strength of the different designs.FindingsThe introduction of the LBV structure decreases the elastic modulus of the implant. Longitudinal LBV type screws demonstrated the lowest insertion torque (associated with lower bone damage) while still displaying promising torsional strength and removal force compared with full-thread screws. The use of LBV structure can promote improved functional performances with respect to the reference thread, enabling the use of lattice structures in the biomedical sector.Originality/valueThe paper fulfils an identified interest in designing customized implants with improved primary stability and promising features for secondary stability.

Customizable 3D Printed Implants Containing Triamcinolone Acetonide: Development, Analysis, Modification, and Modeling of Drug Release.

Three-dimensional-printed customizable drug-loaded implants provide promising opportunities to improve the current therapy options. In this study, we present a modular implant in which shape, dosage, and drug release can be individualized independently of each other to patient characteristics to improve parenteral therapy with triamcinolone acetonide (TA) over three months. This study focused on the examination of release modification via fused deposition modeling and subsequent prediction. The filaments for printing consisted of TA, ethyl cellulose, hypromellose, and triethyl citrate. Two-compartment implants were successfully developed, consisting of a shape-adaptable shell and an embedded drug-loaded network. For the network, different strand widths and pore size combinations were printed and analyzed in long-term dissolution studies to evaluate their impact on the release performance. TA release varied between 8.58 ± 1.38 mg and 21.93 mg ± 1.31 mg over three months depending on the network structure and the resulting specific surface area. Two different approaches were employed to predict the TA release over time. Because of the varying release characteristics, applicability was limited, but successful in several cases. Using a simple Higuchi-based approach, good release predictions could be made for a release time of 90 days from the release data of the initial 15 days (RMSEP ≤ 3.15%), reducing the analytical effort and simplifying quality control. These findings are important to establish customizable implants and to optimize the therapy with TA for specific intra-articular diseases.

TOTAL KNEE ARTHROPLASTY IN PATIENTS WITH SKELETAL DYSPLASIA

AbstractIntroductionTotal knee replacement (TKR) in patients with skeletal dysplasia is technically challenging surgery due to deformity, joint contracture, and associated co-morbidities. The aim of this study is to follow up patients with skeletal dysplasia following a TKR.MethodologyWe retrospectively reviewed 22 patients with skeletal dysplasia who underwent 31 TKRs at our institution between 2006 and 2022. Clinical notes, operative records and radiographic data were reviewed.ResultsAchondroplasia was the most common skeletal dysplasia (8), followed by Chondrodysplasia punctata (7) and Spondyloepiphyseal dysplasia (5). There were fourteen men and eight women with mean age of 51 years (28 to 73). The average height of patients was 1.4 metres (1.16–1.75) and the mean weight was 64.8 Kg (34.3–100). The mean follow up duration was 68.32 months (1–161). Three patients died during follow up. Custom implants were required in twelve patients (38.71%). Custom jigs were utilised in six patients and two patients underwent robotic assisted surgery. Hinged TKR was used in seventeen patients (54.84%), posterior stabilised TKR in nine patients (29.03%), and cruciate retaining TKR in five patients (16.13%). One patient underwent a patella resurfacing for persistent anterior knee pain and another had an intra-operative medial tibial plateau fracture which was managed with fixation. No revisions occurred during the follow up period.ConclusionDespite the technical challenges and complexity of TKR within this unique patient group, we demonstrate good implant survivorship during the study period. Cross sectional imaging is recommended preoperatively for precise planning and templating.

CAN RECONSTRUCTION IN REVISION TOTAL HIP ARTHROPLASTY WITH MAJOR ACETABULAR BONE LOSS BE REPRODUCIBLE AND RELIABLE?

Contemporary acetabular reconstruction in major acetabular bone loss often involves the use of porous metal augments, a cup-cage construct or custom implant. The aims of this study were: To determine the reproducibility of a reconstruction algorithm in major acetabular bone loss. To determine the subsequent success of reconstruction performed in terms of re-operation, all-cause revision and Oxford Hip Score (OHS) and to further define the indications for custom implants in major acetabular bone loss.Consecutive series of Paprosky Type III defects treated according to a reconstruction algorithm. IIIA defects were planned to use a superior augment and hemispherical cup.IIIB defects were planned to receive either augment and cup, cup-cage or custom implant.105 procedures in cohort 100 patients (5 bilateral) with mean age 73 years (42–94).IIIA defects (50 cases) − 72.0% (95%CI 57.6–82.1) required a porous metal augment the remainder treated with a hemispherical cup alone. IIIB defects (55 cases) 71.7% (95%CI 57.6–82.1) required either augments or cup-cage. 20 patients required a hemispherical cup alone and 6 patients received a custom-made implant.Mean follow up of 7.6 years. 6 re-revisions were required (4 PJI, 2 peri-prosthetic fractures &amp; 1 recurrent instability) with overall survivorship of 94.3% (95% CI 97.4–88.1) for all cause revision. Single event dislocations occurred in 3 other patients so overall dislocation rate 3.8%. Mean pre-op OHS 13.8 and mean follow-up OHS 29.8.Custom implants were used in: Mega-defects where AP diameter &gt;80mm, complex discontinuity and massive bone loss in a small pelvis (i.e., unable to perform cup-cage)A reconstruction algorithm can &gt;70% successfully predict revision construct which thereafter is durable with a low risk of re-operation. Jumbo cup utilized &lt;1/3 of cases when morphology allowed. The use of custom implants has been well defined in this series and accounts for &lt;5% of cases.

Major clinical approaches of prefabricated and customized prostheses for the temporomandibular joint: a systematic review

Introduction: The temporomandibular joint (TMJ) is composed of dense fibrocartilage formed between the mandibular condyle and the temporal bone. The high collagen content of this disc provides great rigidity and durability. Osteoarthritis-like degenerative joint disease belonging to temporomandibular disorder (TMD) is a destruction of bone and cartilage with a consequent inflammation that enhances tissue destruction. As a treatment, the implantation of a total alloplastic TMJ prosthesis is an innovative approach to the treatment of TMD. There are two types of prefabricated (stock) and custom computer-aided design/computer-aided manufacturing (CAD/CAM) systems. Objective: The present study aimed to carry out a concise systematic review of the major clinical approaches of prefabricated and customized prostheses for the temporomandibular joint. Methods: The systematic review rules of the PRISMA Platform were followed. The search was carried out from February to May 2023 in the Scopus, PubMed, Science Direct, Scielo, and Google Scholar databases, using articles from 2018 to 2023. Results and Conclusion: A total of 107 articles were found, 34 articles were evaluated and 19 were included and developed in this systematic review study. Considering the Cochrane tool for risk of bias, the overall assessment resulted in 21 studies with a high risk of bias and 15 studies that did not meet GRADE. It was concluded that the clinical results of the stock and CAD/CAM prostheses suggested major improvements in mouth opening and reduced pain as a result of the rehabilitation of temporomandibular joint function. The results showed comparable data for the two types of prosthesis design at 6 months postoperatively. Thus, both temporomandibular joint and custom implants work well despite the additional advantages of custom prostheses, along with increasing access to digital technology, which may result in custom devices dominating the market in total temporomandibular joint replacement systems.

ISCHIAL SCREW FIXATION CAN PREVENT CUP MIGRATION IN 3D-PRINTED CUSTOM ACETABULAR COMPONENTS FOR COMPLEX HIP RECONSTRUCTION

Custom acetabular components have become an established method of treating massive acetabular bone defects in hip arthroplasty. Complication rates, however, remain high and migration of the cup is still reported. Ischial screw fixation (IF) has been demonstrated to improve mechanical stability for non-custom, revision arthroplasty cup fixation. We hypothesise that ischial fixation through the flange of a custom acetabular component aids in anti-rotational stability and prevention of cup migration.Electronic patient records were used to identify a consecutive series of 49 custom implants in 46 patients from 2016 to 2022 in a unit specializing in complex joint reconstruction. IF was defined as a minimum of one screw inserted into the ischium passing through a hole in a flange on the custom cup.The mean follow-up time was 30 months. IF was used in 36 cups. There was no IF in 13 cups. No difference was found between groups in age (68.9 vs. 66.3, P = 0.48), BMI (32.3 vs. 28.2, P = 0.11) or number of consecutively implanted cups (3.2 vs. 3.6, P = 0.43). Aseptic loosening with massive bone loss was the primary indication for revision. There existed no difference in Paprosky grade between the groups (P = 0.1). 14.2% of hips underwent revision and 22.4% had at least one dislocation event.No ischial fixation was associated with a higher risk of cup migration (6/13 vs. 2/36, X2 = 11.5, P = 0.0007). Cup migration was associated with an increased risk for all cause revision (4/8 vs. 3/38, X2 = 9.96, P = 0.0016, but not with dislocation (3/8 vs. 8/41, X2 = 1.2, P = 0.26).The results suggest that failure to achieve adequate ischial fixation, with screws passing through the flange of the custom component into the ischium, increases the risk of cup migration, which, in turn, is a risk factor for revision.

An investigation into tubular 3D printed coronary heart stents

The use of three-dimensional printing (3DP), an additive manufacturing technique, has become increasingly popular in various industries. The medical industry is one of the sectors that has rapidly adopted 3DP for tasks such as training surgeons and creating custom implants. Researchers have also proposed using 3DP to produce bioabsorbable stents that can break down in the patient's body over time. This study focuses on modifying a hobbyist 3D printer to print tubular structures such as stents. Optical and destructive testing were conducted on the stents printed on both the tubular printer and a traditional 3D printer. The results indicate that the flexibility of the tube stents, coupled with their continuous strands, makes them a viable option for further research. Additionally, the concept of using a tubular printer suggests that on-demand custom coronary stents may be a feasible solution for cardiovascular surgeries in the future.

The use of a 3D printed titanium implant for arthrodesis in the management of large osseous defects in the ankle

BackgroundLarge osseous defects (LOD) in the ankle occur because of multiple aetiologies. Advancement in 3-dimensional (3D) printing technologies has led to the use of custom implants and instrumentation their management. A 3D printed patient-specific porous titanium cage which allows for peripheral osteo-integration and autogenous bone-grafting could be an ideal implant in these cases. MethodsRetrospective review of a multi-centre, multi-surgeon consecutive cohort of patients requiring either TTC or AA for a large osseous defect between June 2019 – August 2020. A custom titanium prosthesis was 3D-printed according to CT measurements for implantation. ResultsMean follow up was 19.5 months (range 12–24 months). Plain radiographs and CT scans at 12 months confirmed osseointegration (stability) in 11of 13 patients (84%). Two patients developed late infection, one requiring revision surgery. Conclusions3D-Printed titanium implants in the management of LODs in the ankle offer a comparable success rate to other reported procedures, with unlimited geometric possibilities in the design allowing for accurate length correction. Their structural stability may offer an advantage over conventional bone graft techniques and limits the amount of bone-graft required. Levels of evidenceLOE III

FINITE ELEMENT ANALYSIS OF CUSTOMIZED KNEE IMPLANTS BY VARYING LOADS DURING FLEXION-EXTENSION MOVEMENT

A customized knee implant numerical modeling using finite element analysis (FEA) during flexion extension has been investigated in this paper with varying loads with an objective of studying its kinematics. Computed tomography (CT) images of 15 osteoarthritis subjects’ images were used in this work. Various morphological characteristics were extracted from clinical images using a commercial CAE software and biomechanical properties were studied on applying standard loads on customized implant and off-the-shelf (OTS) implants. Patient-specific knee implants have been designed according to the morphological characteristics and bone dimension of patient with compressive loads (1500, 1700 and 3000[Formula: see text]N) during normal gait and were compared with the normal knee. Results showed that the stresses are distributed equally to the spacer and the tibial plate, unlike the standard femoral component where the stresses get concentrated on the cut edges. In compressive load, active stress and strain ([Formula: see text]–20[Formula: see text]MPa) are lesser ([Formula: see text]) and in flexion extension also lesser with a scaling factor of 0.785 and 1.0. The designed implant was found to produce similar biomechanical properties when compared to normal knee joint and thus it can be considered as a valuable implant and could replace the standard OTS knee implants.

CUSTOM-MADE PATIENT-SPECIFIC HIGH TIBIAL OSTEOTOMY IMPLANTS AND SURGICAL GUIDES SIGNIFICANTLY IMPROVE CLINICAL OUTCOMES: FIRST-IN-MAN CASE SERIES

High tibial osteotomy (HTO) is a joint preserving alternative to knee replacement for medial tibiofemoral osteoarthritis in younger, more active patients. The procedure is technically challenging and limited also by ‘one size fits all’ plates which can result in patient discomfort necessitating plate removal.This clinical trial evaluated A novel custom-made HTO system – TOKA (3D Metal Printing LTD, Bath, UK) for accuracy of osteotomy correction and improvements in clinical outcome scores.The investigation was a single-arm single-centre prospective clinical trial (IRCCS Istituto Ortopedico Rizzoli; ClinicalTrials.gov NCT04574570), with recruitment of 25 patients (19M/6F; average age: 54.4 years; average BMI: 26.8), all of whom received the TOKA HTO 3D planning and surgery. All patients were predominantly diagnosed with isolated medial knee osteoarthritis and with a varus deformity under 20°. Patients were CT scanned pre- and post-operatively for 3D virtual planning and correctional assessment. All surgeries were performed by the lead clinical investigator – a consultant knee surgeon with a specialist interest in and clinical experience of HTO.On average, Knee Society Scores (KSS) improved significantly (p&lt;0.001) by 27.6, 31.2 and 37.2 percentage points respectively by 3-, 6- and 12-months post-surgery respectively. Other measures assessed during the study (KOOS, EQ5D) produced similar increases.Our early experience using custom implants is extremely promising. We believe the reduced profile of the plate, as well as the reduced invasiveness and ease of surgery contributed to faster patient recovery, and improved outcome scores compared to conventional techniques. These clinical outcome results compare very favourably other case-series with published KOOS scores using different devices.

CLINICAL AND RADIOLOGICAL OUTCOMES OF CUSTOM 3D-PRINTED GLENOID COMPONENTS IN PRIMARY AND REVISION REVERSE POLARITY TOTAL SHOULDER ARTHROPLASTY WITH SEVERE GLENOID BONE LOSS: A MINIMUM TWO-YEAR FOLLOW-UP

The purpose of this study is to report the clinical and radiological outcomes of patients undergoing primary or revision reverse total shoulder arthroplasty using custom 3D printed components to manage severe glenoid bone loss with a minimum of 2-year follow-up.After ethical approval (reference: 17/YH/0318), patients were identified and invited to participate in this observational study. Inclusion criteria included: 1) severe glenoid bone loss necessitating the need for custom implants; 2) patients with definitive glenoid and humeral components implanted more than 2 years prior; 3) ability to comply with patient reported outcome questionnaires. After seeking consent, included patients underwent clinical assessment utilising the Oxford Shoulder Score (OSS), Constant-Murley score, American Shoulder and Elbow Society Score (ASES), and quick Disabilities of the Arm, Shoulder, and Hand Score (quickDASH). Radiographic assessment included AP and axial projections. Patients were invited to attend a CT scan to confirm osseointegration. Statistical analysis utilised included descriptive statistics (mean and standard deviation) and paired t test for parametric data.3 patients had revision surgery prior to the 2-year follow-up. Of these, 2/3 retained their custom glenoid components. 4 patients declined to participate. 5 patients were deceased at the time of commencement of the study. 21 patients were included in this analysis. The mean follow-up was 36.1 months from surgery (range 22–60.2 months). OSS improved from a mean 16 (SD 9.1) to 36 (SD 11.5) (p &lt; 0.001). Constant-Murley score improved from mean 9 (SD 9.2) to 50 (SD 16.4) (p &lt; 0.001). QuickDASH improved from mean 67 (SD 24) to 26 (SD 27.2) (p = 0.004). ASES improved from mean 28 (SD 24.8) to 70 (SD 23.9) (p = 0.007). Radiographic evaluation demonstrated good osseointegration in all 21 included patients.The utility of custom 3D-printed components for managing severe glenoid bone loss in primary and revision reverse total shoulder arthroplasty yields significant clinical improvements in this complex patient cohort.