Orthopedic Devices Research Articles

THEORETICAL JUSTIFICATION OF MEANS OF PHYSICAL THERAPY OF PATIENTS WITH OSTEOCHONDROS OF THE LUMBAR SPINE

Osteochondrosis incidence statistics worldwide indicates that more people suffer from this disease 80% of the population. And more than half of these people unaware of his pathological condition because of the disease is in a latent period of its development. Due to the frequent duration of the disease in therapeutic, as well as a variety of therapeutic options, the treatment of lumbar vertebrae is a special challenge. Today, lumbar osteochondrosis is considered a serious disease that occurs in people of all ages and has a steady tendency to youth, more and more often the disease is diagnosed in people under 20 years of age. The basic treatment and the most widespread diseases on an osteochondrosis on department of a backbone are listed. Yes, according to the data statistics of the Ministry of Health of Ukraine, already in 2001 osteochondrosis spine was 2.91% of disability in diseases and injuries of the musculoskeletal system, and primary disability was 1.5 per 100 thousand population. Diagnosis and treatment of this severe form many scientific works are devoted to spinal lesions clinical, neurological and radiological orientation. The article analyzes the issue of the beneficial effects of physical therapy for patients with osteochondrosis of the lumbar spine. Osteochondrosis is a degenerative-dystrophic disease of the spinal discs of multifactorial origin, which subsequently provokes a change in the structure of the vertebrae and intervertebral discs, limiting their natural functionality. The vertebrae become less durable and more prone to injury, and the intervertebral discs lose some of their elasticity. This disease is characterized by dystrophy in the intervertebral discs. As you know, disks are designed to provide flexibility and mobility to our spine. When the disc becomes flat, depleted, then the vertebrae converge, compressing the vessels and nerve roots. Hence arise pain and swelling. This condition is accompanied by metabolic disorders in the soft tissues surrounding the spine. As a result of osteochondrosis, the risk of injuries and the emergence of serious diseases of the spine, in particular, protrusions and hernias of the intervertebral discs, Schmorl's hernia, scoliosis and others. Despite the fact that there are a huge number of methods for the treatment and rehabilitation of osteochondrosis of the spine, the spread of the disease both in Ukraine and in the world is constantly growing. Currently, the problem of prevention and treatment of these patients is one of the leaders in traumatology. Treatment of osteochondrosis is mainly carried out using conservative methods, which are aimed at eliminating pain, dysfunction of the spinal roots and preventing the progression of degenerative changes in the structure of the spine. Comprehensive conservative therapy includes: a regime of reducing the physical load on the spine, prosthetic and orthopedic devices, physiotherapy procedures and drugs aimed at muscle relaxation, elimination of edema and pain, as well as reflexology. Therapeutic exercise and massage also play an important role in complex treatment.

Clinical Metagenomic Sequencing for Species Identification and Antimicrobial Resistance Prediction in Orthopedic Device Infection.

ABSTRACTDiagnosis of orthopedic device-related infection is challenging, and causative pathogens may be difficult to culture. Metagenomic sequencing can diagnose infections without culture, but attempts to detect antimicrobial resistance (AMR) determinants using metagenomic data have been less successful. Human DNA depletion may maximize the amount of microbial DNA sequence data available for analysis. Human DNA depletion by saponin was tested in 115 sonication fluid samples generated following revision arthroplasty surgery, comprising 67 where pathogens were detected by culture and 48 culture-negative samples. Metagenomic sequencing was performed on the Oxford Nanopore Technologies GridION platform. Filtering thresholds for detection of true species versus contamination or taxonomic misclassification were determined. Mobile and chromosomal genetic AMR determinants were identified in Staphylococcus aureus-positive samples. Of 114 samples generating sequence data, species-level positive percent agreement between metagenomic sequencing and culture was 50/65 (77%; 95% confidence interval [CI], 65 to 86%) and negative percent agreement was 103/114 (90%; 95% CI, 83 to 95%). Saponin treatment reduced the proportion of human bases sequenced in comparison to 5-μm filtration from a median (interquartile range [IQR]) of 98.1% (87.0% to 99.9%) to 11.9% (0.4% to 67.0%), improving reference genome coverage at a 10-fold depth from 18.7% (0.30% to 85.7%) to 84.3% (12.9% to 93.8%). Metagenomic sequencing predicted 13/15 (87%) resistant and 74/74 (100%) susceptible phenotypes where sufficient data were available for analysis. Metagenomic nanopore sequencing coupled with human DNA depletion has the potential to detect AMR in addition to species detection in orthopedic device-related infection. Further work is required to develop pathogen-agnostic human DNA depletion methods, improving AMR determinant detection and allowing its application to other infection types.

Ultrashort Laser Texturing for Tuning Surface Morphology and Degradation Behavior of the Biodegradable Fe–20Mn Alloy for Temporary Implants

Biodegradable metallic alloys are promising materials for the development of temporary medical implants, including cardiovascular and orthopedic devices. The present work explores the surface modification of a biodegradable Fe–20Mn alloy by means of ultrashort laser texturing and the correlation between the laser‐induced surface morphology and the degradation behavior. In detail, the effect of different processing parameters on surface morphology is explored and compared with the unprocessed surface. It is found that laser texturing can tune the degradation rate, selectively inducing positive (+29%) or negative (−31%) change with respect to the untreated surface.

The Effect of PEEK-Rod Fixation Systems on Finite Element Lumbar Spine Model

Orthopedic fixation devices have been employed in the treatment of spinal diseases. Special fixation devices have been developed to decrease the effect of spinal injuries and deformities and have been used to decrease the neurologic back pain of the patients. In this study, the finite element spine model of an adolescent idiopathic scoliotic patient was constructed. The titanium spinal implant system and the system of polyetheretherketone (PEEK) were compared regarding their stress distributions. The finite element lumbar spine model from L2 to L5 vertebra was obtained from computed tomography scan data. The three-dimensional spine model consisted of four lumbar vertebrae, three intervertebral discs, six facet joints, and the corresponding ligaments. Loading and boundary conditions were applied to the L2-L5 lumbar model. According to the subjected loads and bending moments on the model, stress distributions were evaluated especially on the intervertebral discs, and the screw-rod implant systems both for the titanium and the PEEK-based fixation systems. The disc structures were also analyzed for the effects of adjacent segment disease, which has been reported as a post-operative effect of fusion surgeries. Ansys software was used for the simulation processes of the models without the implant system and the models with different fixation systems. Comparative investigation between different fixation systems showed that the stress distribution values were decreased with the PEEK-based fixation system. Moreover, lower total deformation and equivalent stress values were recorded with the PEEK-based fixation system, especially on L3-L4 and L4-L5 intervertebral discs. Furthermore, both spinal implant systems allowed to decrease the overall loading stress on the whole spine models. And it was concluded that the PEEK-based spinal implant system was considerably reduced the load on the discs and ligaments, and also appeared as a better option in stress reduction and load sharing when compared to the titanium spinal implant system.

Characteristics of needlestick and sharps injuries of the hands in the operating room among orthopedic surgeons in Japan.

Among the reports on needlestick and sharps injuries (NSIs), many are orthopedic-related due to the frequent use of sharp devices such as pins and wires. This study aimed to identify high-risk instruments, the most common injury sites for each instrument, and the circumstances of NSIs of the hand during orthopedic surgeries in Japan. Incidents of exposure to blood or bodily fluids among physicians during orthopedic surgeries reported to the Japan-EPINet between 2000 and 2015 were included in this study. The four most common devices were identified and the associations among years of experience, equipment users, and injured sites were analyzed. We identified 666 cases of NSIs affecting orthopedic surgeons in the operating room. The instrument most frequently responsible for NSIs was suture needles, which were involved in 265 cases (39.7%). The second most common instrument was pins/wires, which was involved in 111 cases (16.6%). NSIs of the hands of orthopedic surgeons were frequently caused by suture needles used in all surgeries, but relatively often caused by orthopedic devices. Orthopedic surgeons must be aware that they are at risk of NSIs and must take appropriate measures and always be cautious when performing surgery, regardless of their years of experience.

Orthosis in the Conservative Treatment of Cranial Cruciate Ligament Rupture in Dogs – Clinical Observations

Abstract Orthoses are increasingly frequently applied orthopedic devices in veterinary medicine. Injury to the knee joint with a rupture of the cranial cruciate ligament is one of the main indications for the use of orthoses in dogs. This study aimed to present the results of treatment of 30 dogs with injured cranial cruciate ligaments using a knee orthosis and describe the reasons for the conservative treatment of cranial cruciate ligament deficiency. The study was conducted between 2017 and 2019 and involved 30 dogs of various breeds aged 7 to 15, weighing from 2.5 kg to 45 kg, diagnosed with cranial cruciate ligament rupture. In the study, a stifle knee orthosis by the Polish manufacturer Admirał (Pl) was used in 29 dogs and, in one case, an orthosis by Balto (USA) was applied. In each case, the orthosis was selected individually, based on the measurements taken. In the twelfth week of treatment using orthoses, the owners of 25 dogs were satisfied with the results of conservative treatment with the application of orthoses. The caretakers of four dogs observed difficulties in the form of slight lameness at rest after prolonged exertion on the previous day. Running difficulty was observed in one dog. In the conducted study, the knee orthosis demonstrated good therapeutic effects in dogs up to 25 kg. In the majority of dogs, a slight increase in the flexion angle of the treated knee joints was observed, X-ray examinations did not show the degenerative disease progress during the studied period.

Medicolegal Sidebar: Are Implant Sales Reps in the Operating Room Legally Untouchable?

Medicolegal Sidebar: Are Implant Sales Reps in the Operating Room Legally Untouchable?

Design of cellular materials for multiscale topology optimization: application to patient-specific orthopedic devices

A flexible problem-specific multiscale topology optimization is introduced to associate different areas of the design domain with diverse microstructures extracted from a dictionary of optimized unit cells. The generation of the dictionary is carried out by exploiting micro-SIMP with AnisoTropic mesh adaptivitY (microSIMPATY) algorithm, which promotes the design of free-form layouts. The proposed methodology is particularized in a proof-of-concept setting for the design of orthotic devices for the treatment of foot diseases. Different patient-specific settings drive the prototyping of customized insoles, which are numerically verified and successively validated in terms of mechanical performances and manufacturability.

A Large Animal Model for Orthopedic Foot and Ankle Research.

Trauma to the soft tissues of the ankle joint distal syndesmosis often leads to syndesmotic instability, resulting in undesired movement of the talus, abnormal pressure distributions, and ultimately arthritis if deterioration progresses without treatment. Historically, syndesmotic injuries have been repaired by placing a screw across the distal syndesmosis to provide rigid fixation to facilitate ligament repair. While rigid syndesmotic screw fixation immobilizes the ligamentous injury between the tibia and fibula to promote healing, the same screws inhibit normal physiologic movement and dorsiflexion. It has been shown that intact screw removal can be beneficial for long-term patient success; however, the exact timing remains an unanswered question that necessitates further investigation, perhaps using animal models. Because of the sparsity of relevant preclinical models, the purpose of this study was to develop a new, more translatable, large animal model that can be used for the investigation of clinical foot and ankle implants. Eight (8) skeletally mature sheep underwent stabilization of the left and right distal carpal bones following transection of the dorsal and interosseous ligaments while the remaining two animals served as un-instrumented controls. Four of the surgically stabilized animals were sacrificed 6 weeks after surgery while the remaining four animals were sacrificed 10 weeks after surgery. Ligamentous healing was evaluated using radiography, histology, histomorphometry, and histopathology. Overall, animals demonstrated a high tolerance to the surgical procedure with minimal complications. Animals sacrificed at 10 weeks post-surgery had a slight trend toward mildly decreased inflammation, decreased necrotic debris, and a slight increase in the healing of the transected ligaments. The overall degree of soft tissue fibrosis/fibrous expansion, including along the dorsal periosteal surfaces/joint capsule of the carpal bones was very similar between both timepoints and often exhibited signs of healing. The findings of this study indicate that the carpometacarpal joint may serve as a viable location for the investigation of human foot and ankle orthopedic devices. Future work may include the investigation of orthopedic foot and ankle medical devices, biologic treatments, and repair techniques in a large animal model capable of providing translational results for human treatment.

Effectiveness and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial.

Background:More than 80% of the population suffer from low back pain at some time during their lives. An orthopedic device (LSM-01) will be used to alleviate back pain caused by muscle tension. LSM-01, which has a rotating roller, stimulates meridian-muscles around the governor vessel, bladder meridian, and gall bladder meridian.Methods:This study will be a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Subjects will be randomly allocated to the treatment group (LSM-01) or the control group (sham device). The duration of the clinical trial will be 2 weeks. The primary outcomes will be measured using the visual analog scale; the secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and Patient Global Impression of Change. Statistical analysis will be performed for the full study population. Analysis of covariance will be conducted to identify differences in pain before and after the application of the device.Discussion:This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this investigation includes a limited number of subjects. The results of this pilot trial will form a basis for a large-scale clinical trial, which will be conducted in the future.Clinical trial registration:This study protocol is registered with the Clinical Research Information Service (CRIS) of Korea. Clinical trial registration number: CRIS-KCT0006425. Registered: October 5, 2021; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=L&pageSize=10&page=undefined&seq=20056&status=5&seq_group=20056

Management of the pediatric OSAS: what about simultaneously expand the maxilla and advance the mandible? A retrospective non-randomized controlled cohort study

Objective/backgroundThis retrospective non-randomized controlled cohort study aimed to evaluate the efficiency of simultaneous maxillary expansion and mandibular advancement for the management of pediatric OSAS. Patients/methodsThe sample was composed of 94 children treated with an innovative orthopedic device to correct a Class II malocclusion associated with an OSAS. Polysomnographic recordings were performed before and after the treatment. We also included a group of 113 age-matched control patients who had the same pathologies, but who did not receive the orthopedic treatment at the time they undergone polysomnographic exams. Statistical tests evaluated the significance of the evolution of these data, both in treated and untreated control patients. ResultsAfter nine months (±3 months) of treatment, respiratory OSAS symptoms significantly improved: the AHI significantly decreased as it became inferior to the pathological threshold (<1) for 53% of the treated patients' sample, with a greater proportion within the youngest age group (63%). Only two patients still presented a moderate OSAS after treatment, with an AHI slightly superior to 5. This positive evolution of OSAS respiratory symptoms was not observed within the control group, highlighting the real impact of the orthopedic treatment over the children's natural growth. However, sleep remained fragmented following the treatment. ConclusionsThis study confirmed that simultaneous maxillary expansion and mandibular advancement induced a modification of the maxilla-mandibular anatomy, helping in the significant improvement of the respiratory OSAS symptoms. Then, considering these preliminary results, pediatric OSAS can be managed with this new orthopedic strategy, especially if it is performed early.

Multi-attribute parametric optimisation of shape memory polymer properties for adaptive orthopaedic plasters

Fall-related injuries and road accidents often demand orthopaedic emergency care and management in hospitals. Early and effective fracture treatment immobilisation techniques are essential for stabilising the musculoskeletal system of the patient. During past decades, shape memory polymers (SMPs) have rapidly been developed and they have exhibited their potential to replace traditional plaster of Paris or wood casting orthopaedic treatment practices. In this context, SMPs must match all the operational conditions of traditional materials while keeping SMP's superior qualities such as adjustability and ease of removal for observation and reapplication. In order to achieve their significantly delicate shape memory effect and shape fixity properties, SMP needs an accurately engineered material characterisation process. Therefore, this research comprises and extensive evaluation of shape memory polymer composites’ (SMPCs’) thermo-mechanical properties under ASTM/ISO standards for extended use in the orthopaedic medical field.The robust Taguchi (L18) optimisation approach combined with a multi-responses grey relational study was employed to achieve optimum SMPC fabrication parameters for orthopaedic applications while prioritising the required thermo-mechanical and shape memory properties. It was determined that the number of fabric layers is the most decisive parameter (P-value 0.013, relative contribution > 37.86%) for achieving SMPs’ delicate and crucial properties for biomedical applications. In this study, it was found that one layer of glass fibre (SMP weight fraction > 89%) provided the optimum thermo-mechanical and shape memory properties. Moreover, optimised control variables assured the self-life of the SMP casting material by retaining a programmed shape for 30 days (shape fixity ratio >98%), which is an exclusive property for an orthopaedic device. This study provides first-hand pre-engineered experimental program optimisation techniques to meet the rapid growth of SMPC orthopaedic non-invasive smart plasters and adaptive devices.

Perspective on the integration of optical sensing into orthopedic surgical devices

.SignificanceOrthopedic surgery currently comprises over 1.5 million cases annually in the United States alone and is growing rapidly with aging populations. Emerging optical sensing techniques promise fewer side effects with new, more effective approaches aimed at improving patient outcomes following orthopedic surgery.AimThe aim of this perspective paper is to outline potential applications where fiberoptic-based approaches can complement ongoing development of minimally invasive surgical procedures for use in orthopedic applications.ApproachSeveral procedures involving orthopedic and spinal surgery, along with the clinical challenge associated with each, are considered. The current and potential applications of optical sensing within these procedures are discussed and future opportunities, challenges, and competing technologies are presented for each surgical application.ResultsStrong research efforts involving sensor miniaturization and integration of optics into existing surgical devices, including K-wires and cranial perforators, provided the impetus for this perspective analysis. These advances have made it possible to envision a next-generation set of devices that can be rigorously evaluated in controlled clinical trials to become routine tools for orthopedic surgery.ConclusionsIntegration of optical devices into surgical drills and burrs to discern bone/tissue interfaces could be used to reduce complication rates across a spectrum of orthopedic surgery procedures or to aid less-experienced surgeons in complex techniques, such as laminoplasty or osteotomy. These developments present both opportunities and challenges for the biomedical optics community.

The use of orthopedic surgical devices for forensic identification: A systematic review.

Background and aim:Identification of human bodies is a necessary step in forensic practice. DNA analysis, fingerprints, and dental charting are considered conventional identification methods. However, these methods are not always applicable. Orthopedic surgical implantable devices provide valuable identity information when conventional methods of identification are not applicable or in challenging circumstances. This paper aims to review the usage of orthopedic implantable devices for forensic human identification.Methods:A search for relevant articles using the PubMed database in January 2021 identified 8 articles that met the inclusion criteria.Results:These articles highlighted the importance of the use of orthopedic implantable devices as an additional method for positive identification, especially in disaster situations. It is a method that needs antemortem and postmortem radiographs, comprehensive information of the orthopedic implantable device like company and serial number, logo, name, medical records of previous surgical intervention, and for the family member’s history to match with the identification details.Conclusions:Efforts should be made to include all information pertaining to orthopedic implantable devices in the medical records. Educating and training forensic experts on the use of such devices in the identification process is essential, as this technique is practical, low-cost, and time-saving. (www.actabiomedica.it)

Digital Analysis in Hip Circulation and Biomechanical Changes in The Lower Limb in Perthes' Disease

Worldwide, the treatment of Perthes' disease in children and adolescents is a complex and unresolved problem. This is a common pathology that, with timely detection and proper therapy, is successfully treated, but in their absence can provoke the development of severe complications and cause early disability. Improving the results of treatment and rehabilitation of children with Legg-Calve-Perthes disease. Our research is based on archival data and on survey observation using digitalization, the total number of patients is 150 children with Legg-Calve-Perthes disease on inpatient treatment at the pediatric orthopedics clinic of the RSSPMC of Traumatology and Orthopedics of the Ministry of Health of the Republic of Uzbekistan for the period from 2008 to 2022. All patients had previously undergone conservative treatment of congenital hip dislocation. In the early stages of the pathology, 69.6% of children aged 3-6 years complained of fatigue in the hip joint after a long walk or run but did not notice pain. An orthopedic device has been developed to achieve maximum unloading of the hip joint when walking. The proposed device is convenient and when used, maximum unloading of the hip joint is achieved when walking.

Shear testing and failure modelling of calcium phosphate coated AZ31 magnesium alloys for orthopaedic applications

Magnesium orthopaedic fracture fixation devices can potentially provide significant clinical benefits, such as the elimination of secondary surgeries for device removal due to in-vivo resorption and reduced stress shielding due to reduced device stiffness. However, development, approval, and clinical adoption of magnesium devices has been hindered by the excessively high rates of in-vivo corrosion such that the structural integrity of the device can be catastrophically reduced before fracture healing occurs. Coating of devices with calcium phosphate coatings has been shown to significantly reduce corrosion rates, while enhancing osseointegration. However, the adhesion strength between the CaP coatings and magnesium substrates has not been previously investigated. Clinical insertion of fracture fixation devices such as intramedullary nails and k-wires will impose significant shear loading on the coated surface of the implant. If the effective shear strength of the coating-device interface is not sufficiently high, the coating will be damaged and removed during device insertion. In the current study a bespoke experimental-computational approach is developed to provide a new understanding of the relationship between coating thickness, surface roughness, and effective shear strength of the CaP coating- Mg substrate interface. Nine test cases were created by adjusting either the deposition time (3 thickness values) or the surface treatment of the Mg alloy using SiC paper (3 roughness values) and double-lap shear testing was performed for these coating configurations. Strain development in the Mg substrates was monitored using strain gauges, and failure stress was determined for each configuration. Test results revealed that the effective shear strength of the coating-substrate interface is significantly higher for coatings on the rougher substrate surfaces when compared to those on smoother surfaces. Coating thickness was not found to significantly influence the effective shear strength over the range considered in this study (0.37–1.34 μm). Micro-scale finite element models of lap-shear tests were constructed using experimental profilometry data. Simulations of rough coating-substrate interfaces reveal that significant localised compression occurs at the coating-substrate interface in regions of large asperities. A novel cohesive zone formulation has been developed to simulate compression induced shear hardening, and the resultant simulations are found to accurately predict the significantly higher effective shear strength measured experimentally for rougher coatings compared to smoother Mg substrate surfaces.

Carbon Nanotube‐Based Reinforced Polymers for Medical Applications: Improving Impact Strength of Polymer‐Polymer Composites

There is a continuous need for innovative biomaterials with advanced properties to meet the biomechanical requirements of orthopedic implants and interventional devices. Recent research findings show that using material composites leads to significantly improved properties, which are beneficial for medical applications. Therefore, this work aims at studying polymer‐polymer composites of high‐density polyethylene (HDPE) and ultrahigh molecular weight polyethylene (UHMWPE), which were mixed with and without reinforcement of multiwall carbon nanotubes (MWCNTs) in two steps. An extensive characterization workflow including mechanical tensile tests, tribological performance, and surface characteristics was used to analyze the reinforced polymer‐polymer composite samples. The results of the mechanical tests showed that the developed MWCNT‐reinforced samples achieved better performance, due to a higher yield point that is the highest in the sample with 48.5% HDPE‐50% UHMWPE‐0.5% MWCNTs, a higher value in the hardness test peaking in the sample with 49.5% HDPE‐50% UHMWPE‐0.5% MWCNTs, and a lower friction coefficient in HDPE‐UHMWPE‐MWCNTs samples. Overall, the reinforcement of polymer‐polymer composites with MWCNTs led to a significant improvement of the material characteristics required for the designated use in orthopedic implants and interventional biopsy needles, which will lead to improved clinical results.

Material selection for biomedical application in additive manufacturing using TOPSIS approach

In ortho-prosthetic industries, the latest development of rapid prototyping is introduced, specifically process of manufacturing orthopedic assistive devices is analysed its use has been widely expanded in orthopaedic operation. These tools are used for correct posture or movement (orthotics) or to auxiliary part of respective shape (prosthetics) while maintaining function. The production of customized base or ankle prostheses still depend on the unhurried and laborious stages of outdated plaster model making technology. Additive manufacturing technology in which three-dimensional substances can be directly created based on data computer-aided-design of layered objects to manufacture new and modified medical equipment. The motive of this paper is to search out the materials for biomedical application and then prioritize the suitable materials by TOPSIS (technique for order performance by similarity to ideal solution) approach. This approach will provide the rank of the suitable materials, which fit for biomedical products or device. Clinical trials were conducted on the prosthesis, or it was successful in terms of wearing practice, looks (colour), and adoption of materials and technology.

Cyclic Fatigue and Creep Resistance Testing of the PUMA SystemTM

Category:Ankle; Basic Sciences/Biologics; TraumaIntroduction/Purpose:The PUMA System (Panther Orthopedics, Sunnyvale, CA) is an FDA cleared. superelastic, nitinol based fixation device for the ankle syndesmosis which provides stabilization without over-compression or loosening due to creep from cyclic loading. Objective The objective of this study was to test resistance to lengthening (creep) of the PUMA System in cyclic fatigue testing.Methods:Five PUMA System devices, each having a nitinol Body consisting of six layers, were cycle-tested between 20/40 pounds per cubic foot (lb/ft3) polyurethane foam Bone Blocks (Figure 1).[1] The PUMA System devices were set up with an initial device Active Length of approximately 66 millimeters (mm) between their polyether ether ketone (PEEK) Anchor buttons. All devices were tightened to a minimum of 11.1 Newtons (2.5 pounds force) and cycled at 5 cycles per second (5 Hz) for 4500 cycles to 2.4 mm displacement. Device Active Length was recorded pre- and post-testing. Devices were visually inspected for any break in the 30 nitinol layers. [1] ASTM F1839: Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments.Results:None of the 30 layers incorporated in the 5 PUMA SystemTM device Bodies failed due to cyclic fatigue. Also, there was little-to-no difference between pre- and post-testing Active Length (Figure 2). More specifically an average increase of only 0.2% in length with a with a Standard Deviation of 0.16% evidences no significant creep (Table 1).Conclusion:The PUMA SystemTM allows for ankle syndesmosis repair with an implant that experiences no significant creep as demonstrated in cyclic-fatigue testing under challenging displacement cycle testing.

Role of qualification and validation in medical device industry: a study

The need for orthopedic implants is increasing due to the rise in the number of accidents. As people begin to age, they begin to experience pain in their joints, bones, and wrists. If it is not managed with medication, an orthopedic implant may be deemed as the best solution. As per the Bureau of Indian Standard Research, the global market for orthopedic products in 2016 in US dollars was 4.20 billion. Industries seem to have an annual growth rate of 6.1 percent when compared with the previous year, which means the market is expected to reach 61.02 billion dollars by 2023. Therefore, the demand for orthopedic devices is significant and the quality of implants manufactured should be strictly controlled and checked for human health safety worldwide. Nowadays, the regulatory agencies also focus on every medical device manufacturing industry with highly stringent needs. Therefore, the knowledge of standards, validation, and differences between Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (CGMP) is highly important. Therefore, this paper focuses on the importance of validation in detail for the safety of patients.