K. Willemsen
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6 records found
1
Osteoarthritis of the hip is a painful and debilitating condition commonly occurring in humans and dogs. One of the main causes that leads to hip osteoarthritis is hip dysplasia. Although the current surgical methods to correct dysplasia work satisfactorily in many circumstances, these are associated with serious complications, tissue resorption, and degeneration. In this study, a one-step fabrication of a regenerative hip implant with a patient-specific design and load-bearing properties is reported. The regenerative hip implant is fabricated based on patient imaging files and by an extrusion assisted 3D printing process using a flexible, bone-inducing biomaterial. The novel implant can be fixed with metallic screws to host bone and can be loaded up to physiological loads without signs of critical permanent deformation or failure. Moreover, after exposing the hip implant to accelerated in vitro degradation, it is confirmed that it is still able to support physiological loads even after losing ≈40% of its initial mass. In addition, the osteopromotive properties of the novel hip implant is demonstrated as shown by an increased expression of osteonectin and osteocalcin by cultured human mesenchymal stem cells after 21 days. Overall, the proposed hip implant provides an innovative regenerative and mechanically stable solution for hip dysplasia treatment.
Background and purpose — The shelf arthroplasty was the regular treatment for residual hip dysplasia before it was substituted by the peri-acetabular osteotomy. Yet, evidence regarding the survival of shelf arthroplasty surgery has never been systematically documented. Hence, we investigated the survival time of the shelf procedure until revision to THA in patients with primary hip dysplasia. Factors that influenced survival and complications were also examined, along with the accuracy of correcting radiographic parameters to characterize dysplasia. Material and methods — The inclusion criteria were studies of human adolescents and adults (> 16 years) with primary or congenital hip dysplasia who were treated with a shelf arthroplasty procedure. Data were extracted concerning patient characteristics, survival time, complications, operative techniques, and accuracy of correcting radiographic parameters. Results — Our inclusion criteria were applicable to 9 studies. The average postoperative Center-Edge Angle and Acetabular Head Index were mostly within target range, but large variations were common. Kaplan–Meier curves (endpoint: conversion to THA) varied between 37% at 20 years’ follow-up and 72% at 35 years’ follow-up. Clinical failures were commonly associated with pain and radiographic osteoarthritis. Only minor complications were reported with incidences between 17% and 32%. Interpretation — The shelf arthroplasty is capable of restoring normal radiographic hip parameters and is not associated with major complications. When carefully selected on minimal osteoarthritic changes, hip dysplasia patients with a closed triradiate cartilage may benefit from the shelf procedure with satisfactory survival rates. The importance of the shelf arthroplasty in relation to peri-acetabular osteotomies needs to be further (re)explored.
A novel treatment for anterior shoulder instability
A biomechanical comparison between a patient-specific implant and the Latarjet procedure
BACKGROUND: Anterior glenohumeral instability with >20% glenoid bone loss is a disorder that can be treated with the Latarjet stabilizing procedure; however, complications are common. The purposes of this study were to (1) evaluate the effect of an anatomic-specific titanium implant produced by 3-dimensional (3D) printing as a treatment option for recurrent shoulder instability with substantial glenoid bone loss and (2) compare the use of that implant with the Latarjet procedure. METHODS: Ten fresh-frozen cadaveric shoulders (mean age at the time of death, 78 years) were tested in a biomechanical setup with the humerus in 30° of abduction and in neutral rotation. The shoulders were tested under 5 different conditions: (1) normal situation, (2) creation of an anterior glenoid defect, (3) implantation of an anatomic-specific titanium implant produced by 3D printing, and the Latarjet procedure (4) with and (5) without 10 N of load attached to the conjoined tendon. In each condition, the humerus was translated 10 mm anteriorly relative to the glenoid, and the maximum peak translational force that was necessary for this translation was measured. RESULTS: After creation of the glenoid defect, the mean translational peak force decreased by 30% ± 6% compared with that for the normal shoulder. After restoration of the original glenoid anatomy, the translational force needed to dislocate the humeral head from the glenoid significantly increased compared with that in the defect condition-to 119% ± 16% of normal (p < 0.01) with the 3D-printed anatomic-specific implant and to 121% ± 48% of normal (p < 0.01) following the Latarjet procedure. No significant differences in mean translational force were found between the anatomic-specific implant and the Latarjet procedure (p = 0.72). CONCLUSIONS: The mean translational peak force needed to dislocate the humerus 10 mm anteriorly on the glenoid was higher after glenoid restoration with the 3D-printed anatomic-specific implant compared with when the glenoid had a 20% surface defect but also compared with when the glenoid was intact. No differences in mean translational peak force were found between the 3D-printed anatomic-specific glenoid implant and the Latarjet procedure, although there was less variability in the 3D-implant condition. CLINICAL RELEVANCE: Novel 3D-printing technology could provide a reliable patient-specific alternative to solve problems related to traditional treatment methods for shoulder instability.
Background: Additive manufacturing or three-dimensional (3D) printing of metal implants can provide novel solutions for difficult-to-treat conditions, yet legislation concerning patient-specific implants complicates the implementation of these techniques in daily practice. In this Article, we share our acquired knowledge of the logistical and legal challenges associated with the use of patient-specific 3D-printed implants to treat spinal instabilities. Methods: Two patients with semiurgent cases of spinal instability presented to our hospital in the Netherlands. In case 1, severe kyphotic deformity of the thoracic spine due to neurofibromatosis type 1 had led to incomplete paralysis, and a strong metallic strut extending from C6 to T11 was deemed necessary to provide long-term anterior support. In case 2, the patient presented with progressive paralysis caused by cervicothoracic dissociation due to vanishing bone disease. As the C5–T1 vertebral bodies had mostly vanished, an implant spanning the anterior spine from C4 to T2 was required. Because of the complex and challenging nature of both cases, conventional approaches were deemed inadequate; instead, patient-specific implants were designed with use of CT scans and computer-aided design software, and 3D printed in titanium with direct metal printing. For each implant, to ensure patient safety, a comprehensive technical file (describing the clinical substantiation, technical and design considerations, risk analysis, manufacturing process, and labelling) was produced in collaboration with a university department certified for the development and manufacturing of medical devices. Because the implants were categorised as custom-made or personalised devices under the EU Medical Device Regulation, the usual procedures for review and approval of medical devices by a notified body were not required. Finite-element analyses, compression strength tests, and cadaveric experiments were also done to ensure the devices were safe to use. Findings: The planning, design, production, and insertion of the 3D-printed personalised implant took around 6 months in the first patient, but, given the experience from the first case, only took around 6 weeks in the second patient. In both patients, the surgeries went as planned and good positioning of each implant was confirmed. Both patients were discharged home within 1 week after the surgery. In the first patient, a fatigue fracture occured in one of the conventional posterior fusion rods after 10 months, which we repaired, without any deformation of the spine or signs of failure of the personalised implant observed. No other adverse events occurred up to 25 months of follow-up in case 1 and 6 months of follow-up in case 2. Interpretation: Patient-specific treatment approaches incorporating 3D-printed implants can be helpful in carefully selected cases when conventional methods are not an option. Comprehensive and efficient interactions between medical engineers and physicians are essential to establish well designed frameworks to navigate the logistical and regulatory aspects of technology development to ensure the safety and legal validity of patient-specific treatments. The framework described here could encourage physicians to treat (once untreatable) patients with novel personalised techniques. Funding: Interreg VA Flanders—The Netherlands programme, Applied and Engineering Sciences research programme, the Netherlands Organisation for Scientific Research, and the Dutch Arthritis Foundation Video Abstract.
Introduction: Dislocation is one of the main reasons for revision of total hip arthroplasty but dislocation rates have not changed in the past decades, compromising patients’ well-being. Acetabular cup orientation plays a key role in implant stability and has been widely studied. This article investigates whether there is a consensus on optimal cup orientation, which is necessary when using a navigation system. Methods: A systematic search of the literature in the PubMed, Embase and Cochrane databases was performed (March 2017) to identify articles that investigated the direct relationship between cup orientation and dislocation, including a thorough evaluation of postoperative cup orientation assessment methods. Results: Twenty eight relevant articles evaluating a direct relation between dislocation and cup orientation could not come to a consensus. The key reason is a lack of uniformity in the assessment of cup orientation. Cup orientation is assessed with different imaging modalities, different methodologies, different definitions for inclination and anteversion, several reference planes and distinct patient positions. Conclusions: All available studies lack uniformity in cup orientation assessment; therefore it is impossible to reach consensus on optimal cup orientation. Using navigation systems for placement of the cup is inevitably flawed when using different definitions in the preoperative planning, peroperative placement and postoperative evaluation. Further methodological development is required to assess cup orientation. Consequently, the postoperative assessment should be uniform, thus differentiating between anterior and posterior dislocation, use the same definitions for inclination and anteversion with the same reference plane and with the patient in the same position.