Compression foot pumps are widely used for the prevention of postoperative venous thrombosis. We tested the efficiency of the pump in ten healthy subjects; the velocity of venous blood flow in the common femoral vein was measured in the horizontal, Trendelenberg (foot-up) and reverse-Trendelenberg (foot-down)
Aims. This study explored the shared genetic traits and molecular interactions between postmenopausal osteoporosis (POMP) and sarcopenia, both of which substantially degrade elderly health and quality of life. We hypothesized that these motor system diseases overlap in pathophysiology and regulatory mechanisms. Methods. We analyzed microarray data from the Gene Expression Omnibus (GEO) database using weighted gene co-expression network analysis (WGCNA), machine learning, and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis to identify common genetic factors between POMP and sarcopenia. Further validation was done via differential gene expression in a new cohort. Single-cell analysis identified high expression cell subsets, with mononuclear macrophages in osteoporosis and muscle stem cells in sarcopenia, among others. A competitive endogenous RNA network suggested regulatory elements for these genes. Results. Signal transducer and activator of transcription 3 (STAT3) was notably expressed in both conditions. Single-cell analysis pinpointed specific cells with high STAT3 expression, and microRNA (miRNA)-125a-5p emerged as a potential regulator. Experiments confirmed the crucial role of STAT3 in osteoclast differentiation and muscle proliferation. Conclusion. STAT3 has emerged as a key gene in both POMP and sarcopenia. This insight
The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons. Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes.Aims
Methods
The use of fluoroscopy in orthopaedic surgery creates risk of radiation exposure to surgeons. Appropriate personal protective equipment (PPE) can help mitigate this. The primary aim of this study was to assess if current radiation protection in orthopaedic trauma is safe. The secondary aims were to describe normative data of radiation exposure during common orthopaedic procedures, evaluate ways to improve any deficits in protection, and validate the use of electronic personal dosimeters (EPDs) in assessing radiation dose in orthopaedic surgery. Radiation exposure to surgeons during common orthopaedic trauma operations was prospectively assessed using EPDs and thermoluminescent dosimeters (TLDs). Normative data for each operation type were calculated and compared to recommended guidelines.Aims
Methods
As an alternative to external fixators, intramedullary lengthening nails (ILNs) can be employed for distraction osteogenesis. While previous studies have demonstrated that typical complications of external devices, such as soft-tissue tethering, and pin site infection can be avoided with ILNs, there is a lack of studies that exclusively investigated tibial distraction osteogenesis with motorized ILNs inserted via an antegrade approach. A total of 58 patients (median age 17 years (interquartile range (IQR) 15 to 21)) treated by unilateral tibial distraction osteogenesis for a median leg length discrepancy of 41 mm (IQR 34 to 53), and nine patients with disproportionate short stature treated by bilateral simultaneous tibial distraction osteogenesis, with magnetically controlled motorized ILNs inserted via an antegrade approach, were retrospectively analyzed. The median follow-up was 37 months (IQR 30 to 51). Outcome measurements were accuracy, precision, reliability, bone healing, complications, and patient-reported outcome assessed by the Limb Deformity-Scoliosis Research Society Score (LD-SRS-30).Aims
Methods
Weightbearing instructions after musculoskeletal injury or orthopaedic surgery are a key aspect of the rehabilitation pathway and prescription. The terminology used to describe the weightbearing status of the patient is variable; many different terms are used, and there is recognition and evidence that the lack of standardized terminology contributes to confusion in practice. A consensus exercise was conducted involving all the major stakeholders in the patient journey for those with musculoskeletal injury. The consensus exercise primary aim was to seek agreement on a standardized set of terminology for weightbearing instructions.Aims
Methods
Our primary aim was to establish the proportion of female orthopaedic consultants who perform arthroplasty via cases submitted to the National Joint Registry (NJR), which covers England, Wales, Northern Ireland, the Isle of Man, and Guernsey. Secondary aims included comparing time since specialist registration, private practice participation, and number of hospitals worked in between male and female surgeons. Publicly available data from the NJR was extracted on the types of arthroplasty performed by each surgeon, and the number of procedures of each type undertaken. Each surgeon was cross-referenced with the General Medical Council (GMC) website, using GMC number to extract surgeon demographic data. These included sex, region of practice, and dates of full and specialist registration.Aims
Methods
The number of females within the speciality of trauma and orthopaedics (T&O) is increasing. The aim of this study was to identify: 1) current attitudes and behaviours of UK female T&O surgeons towards pregnancy; 2) any barriers faced towards pregnancy with a career in T&O surgery; and 3) areas for improvement. This is a cross-sectional study using an anonymous 13-section web-based survey distributed to female-identifying T&O trainees, speciality and associate specialist surgeons (SASs) and locally employed doctors (LEDs), fellows, and consultants in the UK. Demographic data was collected as well as closed and open questions with adaptive answering relating to attitudes towards childbearing and experiences of fertility and complications associated with pregnancy. A descriptive data analysis was carried out.Aims
Methods
Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews.Aims
Methods
Disorders of bone integrity carry a high global disease burden, frequently requiring intervention, but there is a paucity of methods capable of noninvasive real-time assessment. Here we show that miniaturized handheld near-infrared spectroscopy (NIRS) scans, operated via a smartphone, can assess structural human bone properties in under three seconds. A hand-held NIR spectrometer was used to scan bone samples from 20 patients and predict: bone volume fraction (BV/TV); and trabecular (Tb) and cortical (Ct) thickness (Th), porosity (Po), and spacing (Sp).Aims
Methods
Aims. To assess if older symptomatic children with club foot deformity differ in perceived disability and foot function during gait, depending on initial treatment with Ponseti or surgery, compared to a control group. Second aim was to investigate correlations between foot function during gait and perceived disability in this population. Methods. In all, 73 children with idiopathic club foot were included: 31 children treated with the Ponseti method (mean age 8.3 years; 24 male; 20 bilaterally affected, 13 left and 18 right sides analyzed), and 42 treated with primary surgical correction (mean age 11.6 years; 28 male; 23 bilaterally affected, 18 left and 24 right sides analyzed). Foot function data was collected during walking gait and included Oxford Foot Model kinematics (Foot Profile Score and the range of movement and average
Tissue adhesives (TAs) are a commonly used adjunct to traditional surgical wound closures. However, TAs must be allowed to dry before application of a surgical dressing, increasing operating time and reducing intraoperative efficiency. The goal of this study is to identify a practical method for decreasing the curing time for TAs. Six techniques were tested to determine which one resulted in the quickest drying time for 2-octyle cyanoacrylate (Dermabond) skin adhesive. These were nothing (control), fanning with a hand (Fanning), covering with a hand (Covering), bringing operating room lights close (OR Lights), ultraviolet lights (UV Light), or prewarming the TA applicator in a hot water bath (Hot Water Bath). Equal amounts of TA were applied to a reproducible plexiglass surface and allowed to dry while undergoing one of the six techniques. The time to complete dryness was recorded for ten specimens for each of the six techniques.Aims
Methods
Aims. To determine if the results of treatment of adolescents with coccydynia are similar to those found in adults. Adult patients with coccydynia may benefit from injection therapy or operative treatment. There is little data evaluating treatment results in adolescents. We have treated adolescent patients similarly to adults and compared the outcomes. Methods. Overall, 32 adolescents with coccydynia were treated at our institution during a seven-year period; 28 responded to final follow-up questionnaires after a minimum of one year, 14 had been treated with only injection therapy, and 14 had been operated with coccygectomy. We collected data with regards to pain while sitting, leaning forward, rising from a sitting
Orthopaedics has been left behind in the worldwide drive towards diversity and inclusion. In the UK, only 7% of orthopaedic consultants are female. There is growing evidence that diversity increases innovation as well as patient outcomes. This paper has reviewed the literature to identify some of the common issues affecting female surgeons in orthopaedics, and ways in which we can address them: there is a wealth of evidence documenting the differences in the journey of men and women towards a consultant role. We also look at lessons learned from research in the business sector and the military. The ‘Hidden Curriculum’ is out of date and needs to enter the 21st century: microaggressions in the workplace must be challenged; we need to consider more flexible training options and support trainees who wish to become pregnant; mentors, both male and female, are imperative to provide support for trainees. The world has changed, and we need to consider how we can improve diversity to stay relevant and effective. Cite this article:
This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed.Aims
Methods
Patient-reported outcome measures have become an important part of routine care. The aim of this study was to determine if Patient-Reported Outcomes Measurement Information System (PROMIS) measures can be used to create patient subgroups for individuals seeking orthopaedic care. This was a cross-sectional study of patients from Duke University Department of Orthopaedic Surgery clinics (14 ambulatory and four hospital-based). There were two separate cohorts recruited by convenience sampling (i.e. patients were included in the analysis only if they completed PROMIS measures during a new patient visit). Cohort #1 (n = 12,141; December 2017 to December 2018,) included PROMIS short forms for eight domains (Physical Function, Pain Interference, Pain Intensity, Depression, Anxiety, Sleep Quality, Participation in Social Roles, and Fatigue) and Cohort #2 (n = 4,638; January 2019 to August 2019) included PROMIS Computer Adaptive Testing instruments for four domains (Physical Function, Pain Interference, Depression, and Sleep Quality). Cluster analysis (K-means method) empirically derived subgroups and subgroup differences in clinical and sociodemographic factors were identified with one-way analysis of variance.Aims
Methods
The response to the COVID-19 pandemic has raised the profile and level of interest in the use, acceptability, safety, and effectiveness of virtual outpatient consultations and telemedicine. These models of care are not new but a number of challenges have so far hindered widespread take-up and endorsement of these ways of working. With the response to the COVID-19 pandemic, remote and virtual working and consultation have become the default. This paper explores our experience of and learning from virtual and remote consultation and questions how this experience can be retained and developed for the future. Cite this article:
The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited regarding outcomes and potential problems. We report on our early experience and raise awareness for the potential of adverse effects from this device. This is a retrospective review of prospective data collected on all patients treated in our institution using this implant. We report the demographics, nail accuracy, reliability, consolidation index, and cases where concerning clinical and radiological findings were encountered. There were 14 STRYDE nails implanted in nine patients (three male and six female) between June 2019 and September 2020. Mean age at surgery was 33 years (14 to 65). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies.Aims
Methods
The imminent introduction of the new Trauma & Orthopaedic (T&O) curriculum, and the implementation of the Improving Surgical Training initiative, reflect yet another paradigm shift in the recent history of trauma and orthopaedic training. The move to outcome-based training without time constraints is a radical departure from the traditional time-based structure and represents an exciting new training frontier. This paper summarizes the history of T&O training reform, explains the rationale for change, and reflects on lessons learnt from the past. Cite this article:
The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose pragmatic suggestions for its introduction into medical assessment. We reviewed the literature concerning the present status of online medical and surgical assessment to establish the perceived benefits, limitations, and potential problems with this method of assessment.Aims
Methods
The aetiologies of common degenerative spine, hip, and knee pathologies are still not completely understood. Mechanical theories have suggested that those diseases are related to sagittal pelvic morphology and spinopelvic-femoral dynamics. The link between the most widely used parameter for sagittal pelvic morphology, pelvic incidence (PI), and the onset of degenerative lumbar, hip, and knee pathologies has not been studied in a large-scale setting. A total of 421 patients from the Cohort Hip and Cohort Knee (CHECK) database, a population-based observational cohort, with hip and knee complaints < 6 months, aged between 45 and 65 years old, and with lateral lumbar, hip, and knee radiographs available, were included. Sagittal spinopelvic parameters and pathologies (spondylolisthesis and degenerative disc disease (DDD)) were measured at eight-year follow-up and characteristics of hip and knee osteoarthritis (OA) at baseline and eight-year follow-up. Epidemiology of the degenerative disorders and clinical outcome scores (hip and knee pain and Western Ontario and McMaster Universities Osteoarthritis Index) were compared between low PI (< 50°), normal PI (50° to 60°), and high PI (> 60°) using generalized estimating equations.Aims
Methods
Despite the increase in the surgical repair of proximal hamstring tears, there exists a lack of consensus in the optimal timing for surgery. There is also disagreement on how partial tears managed surgically compare with complete tears repaired surgically. This study aims to compare the mid-term functional outcomes in, and operating time required for, complete and partial proximal hamstring avulsions, that are repaired both acutely and chronically. This is a prospective series of 156 proximal hamstring surgical repairs, with a mean age of 48.9 years (21.5 to 78). Functional outcomes were assessed preinjury, preoperatively, and postoperatively (six months and minimum three years) using the Sydney Hamstring Origin Rupture Evaluation (SHORE) score. Operating time was recorded for every patient.Aims
Methods
The COVID-19 pandemic has had a significant impact on the provision of orthopaedic care across the UK. During the pandemic orthopaedic specialist registrars were redeployed to “frontline” specialties occupying non-surgical roles. The impact of the COVID-19 pandemic on orthopaedic training in the UK is unknown. This paper sought to examine the role of orthopaedic trainees during the COVID-19 and the impact of COVID-19 pandemic on postgraduate orthopaedic education. A 42-point questionnaire was designed, validated, and disseminated via e-mail and an instant-messaging platform.Aims
Methods
The use of technology to assess balance and alignment during total knee surgery can provide an overload of numerical data to the surgeon. Meanwhile, this quantification holds the potential to clarify and guide the surgeon through the surgical decision process when selecting the appropriate bone recut or soft tissue adjustment when balancing a total knee. Therefore, this paper evaluates the potential of deploying supervised machine learning (ML) models to select a surgical correction based on patient-specific intra-operative assessments. Based on a clinical series of 479 primary total knees and 1,305 associated surgical decisions, various ML models were developed. These models identified the indicated surgical decision based on available, intra-operative alignment, and tibiofemoral load data.Aims
Methods
This study aimed to identify patients receiving total hip arthroplasty (THA) for trauma during the peak of the COVID-19 pandemic in the UK and quantify the risks of contracting SARS-CoV-2 virus, the proportion of patients requiring treatment in an intensive care unit (ICU), and rate of complications including mortality. All patients receiving a primary THA for trauma in four regional hospitals were identified for analysis during the period 1 March to 1 June 2020, which covered the current peak of the COVID-19 pandemic in the UK.Aims
Methods
Studies have addressed the issue of increasing prevalence of work-related musculoskeletal (MSK) pain among different occupations. However, contributing factors to MSK pain have not been fully investigated among orthopaedic surgeons. Thus, this study aimed to approximate the prevalence and predictors of MSK pain among Saudi orthopaedic surgeons working in Riyadh, Saudi Arabia. A cross-sectional study using an electronic survey was conducted in Riyadh. The questionnaire was distributed through email among orthopaedic surgeons in Riyadh hospitals. Standardized Nordic questionnaires for the analysis of musculoskeletal symptoms were used. Descriptive measures for categorical and numerical variables were presented. Student’s t-test and Pearson’s χ2 test were used. The level of statistical significance was set at p ≤ 0.05.Introduction
Methods
Sickle cell disease (SCD) is an autosomal recessive inherited condition that presents with a number of clinical manifestations that include musculoskeletal manifestations (MM). MM may present differently in different individuals and settings and the predictors are not well known. Herein, we aimed at determining the predictors of MM in patients with SCD at the University Teaching Hospital, Lusaka, Zambia. An unmatched case-control study was conducted between January and May 2019 in children below the age of 16 years. In all, 57 cases and 114 controls were obtained by systematic sampling method. A structured questionnaire was used to collect data. The different MM were identified, staged, and classified according to the Standard Orthopaedic Classification Systems using radiological and laboratory investigations. The data was entered in Epidata version 3.1 and exported to STATA 15 for analysis. Multiple logistic regression was used to determine predictors and predictive margins were used to determine the probability of MM.Aims
Methods
During the pandemic of COVID-19, some patients with COVID-19 may need emergency surgeries. As spine surgeons, it is our responsibility to ensure appropriate treatment to the patients with COVID-19 and spinal diseases. A protocol for spinal surgery and related management on patients with COVID-19 has been reviewed. Patient preparation for emergency surgeries, indications, and contraindications of emergency surgeries, operating room preparation, infection control precautions and personal protective equipments (PPE), anesthesia management, intraoperative procedures, postoperative management, medical waste disposal, and surveillance of healthcare workers were reviewed. It should be safe for surgeons with PPE of protection level 2 to perform spinal surgeries on patients with COVID-19. Standardized and careful surgical procedures should be necessary to reduce the exposure to COVID-19.
The Precice intramedullary limb-lengthening system has demonstrated significant benefits over external fixation lengthening methods, leading to a paradigm shift in limb lengthening. This study compares outcomes following antegrade and retrograde femoral lengthening in both adolescent and adult patients. A retrospective review of prospectively collected data was undertaken of a consecutive series of 107 femoral lengthening operations in 92 patients. In total, 73 antegrade nails and 34 retrograde nails were inserted. Outcome was assessed by the regenerate healing index (HI), hip and knee range of movement (ROM), and the presence of any complications.Aims
Patients and Methods
We prospectively studied the use of intercostal EMG monitoring as an indicator of the accuracy of the placement of pedicle screws in the thoracic spine. We investigated 95 thoracic pedicles in 17 patients. Before insertion of the screw, the surgeon recorded his assessment of the integrity of the pedicle track. We then stimulated the track using a K-wire pedicle probe connected to a constant current stimulator. A compound muscle action potential (CMAP) was recorded from the appropriate intercostal or abdominal muscles. Postoperative CT was performed to establish the
Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image. There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area. By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant
Femoral lengthening using the Intramedullary Skeletal Kinetic Distractor is a new technique. However, with intramedullary distraction the surgeon has less control over the lengthening process. Therefore, 33 femora lengthened with this device were assessed to evaluate the effect of operative variables under the surgeon’s control on the course of lengthening. The desired lengthening was achieved in 32 of 33 limbs. Problems encountered included difficulty in achieving length in eight femora (24%) and uncontrolled lengthening in seven (21%). Uncontrolled lengthening was more likely if the osteotomy was placed with less than 80 mm of the thick portion of the nail in the distal fragment (p = 0.052), and a failure to lengthen was more likely if there was over 125 mm in the distal fragment (p = 0.008). The latter problem was reduced with over-reaming by 2.5 mm to 3 mm. Previous intramedullary nailing also predisposed to uncontrolled lengthening (p = 0.042), and these patients required less reaming. Using the Intramedullary Skeletal Kinetic Distractor, good outcomes were obtained; problems were minimised by optimising the
We report the effect of padding on the efficiency of the pneumatic tourniquet for the upper limb. Varying thicknesses of two commercially-available types of orthopaedic padding (Cellona and Velband) were applied to the arms of 20 volunteers, with three pressure transducers placed directly beneath the padding. A tourniquet was
A flexed knee gait is common in patients with bilateral spastic
cerebral palsy and occurs with increased age. There is a risk for
the recurrence of a flexed knee gait when treated in childhood,
and the aim of this study was to investigate whether multilevel
procedures might also be undertaken in adulthood. At a mean of 22.9 months (standard deviation 12.9), after single
event multi level surgery, 3D gait analysis was undertaken pre-
and post-operatively for 37 adult patients with bilateral cerebral
palsy and a fixed knee gait.Aims
Patients and Methods
Computer hexapod assisted orthopaedic surgery (CHAOS), is a method
to achieve the intra-operative correction of long bone deformities
using a hexapod external fixator before definitive internal fixation
with minimally invasive stabilisation techniques. The aims of this study were to determine the reliability of this
method in a consecutive case series of patients undergoing femoral
deformity correction, with a minimum six-month follow-up, to assess
the complications and to define the ideal group of patients for
whom this treatment is appropriate. The medical records and radiographs of all patients who underwent
CHAOS for femoral deformity at our institution between 2005 and
2011 were retrospectively reviewed. Records were available for all
55 consecutive procedures undertaken in 49 patients with a mean
age of 35.6 years (10.9 to 75.3) at the time of surgery.Aims
Patients and Methods
The use of robots in orthopaedic surgery is an
emerging field that is gaining momentum. It has the potential for significant
improvements in surgical planning, accuracy of component implantation
and patient safety. Advocates of robot-assisted systems describe
better patient outcomes through improved pre-operative planning
and enhanced execution of surgery. However, costs, limited availability,
a lack of evidence regarding the efficiency and safety of such systems
and an absence of long-term high-impact studies have restricted
the widespread implementation of these systems. We have reviewed
the literature on the efficacy, safety and current understanding of
the use of robotics in orthopaedics. Cite this article:
A recent Supreme Court ruling in the United Kingdom
has significantly altered the emphasis of informed consent, moving
from a historically ‘doctor-focused’ to a more ‘patient-focused’ approach,
in line with the situation in other international jurisdictions. The reasons for the change are discussed with some recommendations
about how our attitudes need to change in the future. Cite this article:
Construction of a functional skeleton is accomplished
through co-ordination of the developmental processes of chondrogenesis,
osteogenesis, and synovial joint formation. Infants whose movement Cite this article:
A clinical investigation into a new bone void filler is giving
first data on systemic and local exposure to the anti-infective
substance after implantation. A total of 20 patients with post-traumatic/post-operative bone
infections were enrolled in this open-label, prospective study.
After radical surgical debridement, the bone cavity was filled with
this material. The 21-day hospitalisation phase included determination
of gentamicin concentrations in plasma, urine and wound exudate, assessment
of wound healing, infection parameters, implant resorption, laboratory
parameters, and adverse event monitoring. The follow-up period was
six months. Objective
Method