Aims. The standard of wide tumour-like resection for chronic osteomyelitis (COM) has been challenged recently by adequate debridement. This paper reviews the evolution of surgical debridement for long bone COM, and presents the outcome of adequate debridement in a tertiary
Aims. Calcaneal osteomyelitis remains a difficult condition to treat with high rates of recurrence and below-knee amputation, particularly in the presence of severe soft-tissue destruction. This study assesses the outcomes of single-stage orthoplastic surgical treatment of calcaneal osteomyelitis with large soft-tissue defects. Methods. A retrospective review was performed of all patients who underwent combined single-stage orthoplastic treatment of calcaneal osteomyelitis (01/2008 to 12/2022). Primary outcome measures were osteomyelitis recurrence and below-knee amputation (BKA). Secondary outcome measures included flap failure, operating time, complications, and length of stay. Results. A total of 30 patients (14 female, 16 male; mean age 53.7 years (95% CI 48.0 to 59.5)) underwent combined orthoplastic surgical treatment for BACH “complex” calcaneal osteomyelitis with a median follow-up of 31 months (IQR 11.75 to 49.25). Of these, 19 received a local flap and 11 received a free flap. The most common causes were fracture-related infection (n = 12; 40%) and ulceration (n = 10; 33%); 21 patients (70%) had already undergone at least one operation elsewhere.
Aims. CERAMENT|G is an absorbable gentamicin-loaded biocomposite used as an on-site vehicle of antimicrobials for the treatment of chronic osteomyelitis. The purpose of the present study was to investigate the sole effect of CERAMENT|G, i.e. without additional systemic antimicrobial therapy, in relation to a limited or extensive debridement of osteomyelitis lesions in a porcine model. Methods.
Sinus-track cultures were compared prospectively with cultures from operative specimens in 55 patients with chronic
Aims. This study presents patient-reported quality of life (QoL) over the first year following surgical debridement of long bone osteomyelitis. It assesses the bone involvement, antimicrobial options, coverage of soft tissues, and host status (BACH) classification as a prognostic tool and its ability to stratify cases into ‘uncomplicated’ or ‘complex’. Methods. Patients with long-bone osteomyelitis were identified prospectively between June 2010 and October 2015. All patients underwent surgical debridement in a single-staged procedure at a specialist
We have reviewed 60 patients with primary
The purpose of this report is not to describe a new condition but to remind those who seldom see smallpox of one of its most important and easily recognised complications.
1. The literature on acute osteomyelitis of the maxilla in infants is reviewed and the improvement in the prognosis since the introduction of chemotherapy is noted. 2. The clinical features, diagnosis, surgical anatomy, pathology, and bacteriology are discussed and the constant pathogenicity of the staphylococcus aureus stressed. It is suggested that the first deciduous molar tooth is the centre of the early
1. A technique of closed instillation-suction for the treatment of chronic
This study aimed to investigate the clinical characteristics and outcomes associated with culture-negative limb osteomyelitis patients. A total of 1,047 limb osteomyelitis patients aged 18 years or older who underwent debridement and intraoperative culture at our clinic centre from 1 January 2011 to 31 December 2020 were included. Patient characteristics, infection eradication, and complications were analyzed between culture-negative and culture-positive cohorts.Aims
Methods
This study was designed to characterize the recurrence incidence and risk factors of antibiotic-loaded cement spacer (ALCS) for definitive bone defect treatment in limb osteomyelitis. We included adult patients with limb osteomyelitis who received debridement and ALCS insertion into the bone defect as definitive management between 2013 and 2020 in our clinical centre. The follow-up time was at least two years. Data on patients’ demographics, clinical characteristics, and infection recurrence were retrospectively collected and analyzed.Aims
Methods
Acute bone and joint infections in children are serious, and misdiagnosis can threaten limb and life. Most young children who present acutely with pain, limping, and/or loss of function have transient synovitis, which will resolve spontaneously within a few days. A minority will have a bone or joint infection. Clinicians are faced with a diagnostic challenge: children with transient synovitis can safely be sent home, but children with bone and joint infection require urgent treatment to avoid complications. Clinicians often respond to this challenge by using a series of rudimentary decision support tools, based on clinical, haematological, and biochemical parameters, to differentiate childhood osteoarticular infection from other diagnoses. However, these tools were developed without methodological expertise in diagnostic accuracy and do not consider the importance of imaging (ultrasound scan and MRI). There is wide variation in clinical practice with regard to the indications, choice, sequence, and timing of imaging. This variation is most likely due to the lack of evidence concerning the role of imaging in acute bone and joint infection in children. We describe the first steps of a large UK multicentre study, funded by the National Institute for Health Research, which seeks to integrate definitively the role of imaging into a decision support tool, developed with the assistance of individuals with expertise in the development of clinical prediction tools. Cite this article:
Dead-space management, following dead bone resection, is an important element of successful chronic osteomyelitis treatment. This study compared two different biodegradable antibiotic carriers used for dead-space management, and reviewed clinical and radiological outcomes. All cases underwent single-stage surgery and had a minimum one-year follow-up. A total of 179 patients received preformed calcium sulphate pellets containing 4% tobramycin (Group OT), and 180 patients had an injectable calcium sulphate/nanocrystalline hydroxyapatite ceramic containing gentamicin (Group CG). Outcome measures were infection recurrence, wound leakage, and subsequent fracture involving the treated segment. Bone-void filling was assessed radiologically at a minimum of six months post-surgery.Aims
Methods
Aims. Chronic osteomyelitis may recur if dead space management, after
excision of infected bone, is inadequate. This study describes the
results of a strategy for the management of deep bone infection
and evaluates a new antibiotic-loaded biocomposite in the eradication
of infection from bone defects. Patients and Methods. We report a prospective study of 100 patients with chronic osteomyelitis,
in 105 bones.
The aim of this study was to determine the consensus best practice approach for the investigation and management of children (aged 0 to 15 years) in the UK with musculoskeletal infection (including septic arthritis, osteomyelitis, pyomyositis, tenosynovitis, fasciitis, and discitis). This consensus can then be used to ensure consistent, safe care for children in UK hospitals and those elsewhere with similar healthcare systems. A Delphi approach was used to determine consensus in three core aspects of care: 1) assessment, investigation, and diagnosis; 2) treatment; and 3) service, pathways, and networks. A steering group of paediatric orthopaedic surgeons created statements which were then evaluated through a two-round Delphi survey sent to all members of the British Society for Children’s Orthopaedic Surgery (BSCOS). Statements were only included (‘consensus in’) in the final agreed consensus if at least 75% of respondents scored the statement as critical for inclusion. Statements were discarded (‘consensus out’) if at least 75% of respondents scored them as not important for inclusion. Reporting these results followed the Appraisal Guidelines for Research and Evaluation.Aims
Methods
Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.Aims
Methods
Excision of chronic osteomyelitic bone creates a dead space which must be managed to avoid early recurrence of infection. Systemic antibiotics cannot penetrate this space in high concentrations, so local treatment has become an attractive adjunct to surgery. The aim of this study was to present the mid- to long-term results of local treatment with gentamicin in a bioabsorbable ceramic carrier. A prospective series of 100 patients with Cierny-Mader Types III and IV chronic ostemyelitis, affecting 105 bones, were treated with a single-stage procedure including debridement, deep tissue sampling, local and systemic antibiotics, stabilization, and immediate skin closure. Chronic osteomyelitis was confirmed using strict diagnostic criteria. The mean follow-up was 6.05 years (4.2 to 8.4).Aims
Methods
Intramedullary infection in long bones represents
a complex clinical challenge, with an increasing incidence due to the
increasing use of intramedullary fixation. We report a prospective
case series using an intramedullary reaming device, the Reamer–Irrigator–Aspirator
(RIA) system, in association with antibiotic cement rods for the
treatment of lower limb long
In our unit, we adopt a two-stage surgical reconstruction approach using internal fixation for the management of infected Charcot foot deformity. We evaluate our experience with this functional limb salvage method. We conducted a retrospective analysis of prospectively collected data of all patients with infected Charcot foot deformity who underwent two-stage reconstruction with internal fixation between July 2011 and November 2019, with a minimum of 12 months’ follow-up.Aims
Methods
Flucloxacillin is commonly administered intravenously for perioperative antimicrobial prophylaxis, while oral administration is typical for prophylaxis following smaller traumatic wounds. We assessed the time, for which the free flucloxacillin concentration was maintained above the minimum inhibitory concentration ( A total of 16 pigs were randomly allocated to either intravenous (Group IV) or oral (Group PO) flucloxacillin 1 g every six hours during a 24-hour period. Microdialysis was used for sampling in cancellous and cortical bone, subcutaneous tissue, and the knee joint. In addition, plasma was sampled. The flucloxacillin Aims
Methods
Tuberculosis (TB) is one of the biggest communicable causes of mortality worldwide. While incidence in the UK has continued to fall since 2011, Bradford retains one of the highest TB rates in the UK. This study aims to examine the local disease burden of musculoskeletal (MSK) TB, by analyzing common presenting factors within the famously diverse population of Bradford. An observational study was conducted, using data from the Bradford Teaching Hospitals TB database of patients with a formal diagnosis of MSK TB between January 2005 and July 2017. Patient data included demographic data (including nationality/date of entry to the UK), disease focus, microbiology, and management strategies. Disease incidence was calculated using population data from the Office for National Statistics. Poisson confidence intervals were calculated to demonstrate the extent of statistical error. Disease incidence and nationality were also analyzed, and correlation sought, using the chi-squared test.Aims
Methods
The aim of this study was to assess the clinical application of, and optimize the variables used in, the BACH classification of long-bone osteomyelitis. A total of 30 clinicians from a variety of specialities classified 20 anonymized cases of long-bone osteomyelitis using BACH. Cases were derived from patients who presented to specialist centres in the United Kingdom between October 2016 and April 2017. Accuracy and Fleiss’ kappa (Fκ) were calculated for each variable. Bone involvement (B-variable) was assessed further by nine clinicians who classified ten additional cases of long bone osteomyelitis using a 3D clinical imaging package. Thresholds for defining multidrug-resistant (MDR) isolates were optimized using results from a further analysis of 253 long bone osteomyelitis cases.Objectives
Methods
To characterize the intracellular penetration of osteoblasts and osteoclasts by methicillin-resistant Time-lapse confocal microscopy was used to analyze the interaction of MRSA strain USA300 with primary murine osteoblasts and osteoclasts. The effects of early and delayed antibiotic treatments on intracellular and extracellular bacterial colony formation and cell death were quantified. We tested the effects of cefazolin, gentamicin, vancomycin, tetracycline, rifampicin, and ampicillin, as well as agents used in surgical preparation and irrigation.Aims
Methods
Tuberculous osteomyelitis which does not involve a joint is uncommon and may fail to be diagnosed by an orthopaedic surgeon. We treated 28 lesions of tuberculous osteomyelitis in 25 patients between 1988 and 1995. The duration of symptoms was from two to 39 months, and most of our patients had been treated initially with non-steroidal anti-inflammatory drugs which failed to provide relief. Bone pain which does not promptly respond to analgesic medication is often due to infection or neoplasia. In the early stages, when plain radiographs are normal, MRI or CT may help to localise lesions. On plain radiographs, more advanced lesions may mimic chronic pyogenic osteomyelitis, Brodie’s abscess, tumours or granulomatous lesions. Biopsy is mandatory to confirm the diagnosis, and antituberculous drugs are the mainstay of treatment. When operative findings at biopsy have the features of skeletal tuberculosis curettage of the affected bone may promote earlier healing.
Four cases of osteomyelitis of the pelvis are reported to demonstrate the several clinical syndromes to which this disease can give rise. Extensive surgical drainage and antibiotic treatment led to recovery in all cases.
We reviewed 52 cases of osteomyelitis of the calcaneum. The clinical symptoms and signs were well defined, but different and less dramatic than those of long-bone osteomyelitis. Blood cultures were positive in 41% of cases and tissue cultures in 91%. Routine haematological tests were of little value, and radiological changes were often delayed, and were absent in 12%. With early diagnosis, treatment with antibiotics alone was usually effective, but complications and chronic disease were more likely if there was delay. Early diagnosis is the key to successful treatment. We describe a new physical sign and consider that diagnosis is almost always possible by clinical methods.
1. Five new cases of pyogenic osteomyelitis of the patella are reported. 2. The clinical features are reviewed and the diagnostic pitfalls enumerated.
1. Recent published reports of neonatal osteomyelitis in long bones are reviewed. 2. Six further cases are described. 3. The source of infection is usually the skin or the umbilicus, and the common organisms are the haemolytic streptococcus and staphylococcus aureus. 4. Cases fall into two groups: in one the patient is acutely ill with septicaemia and the bone lesion is of secondary importance; in the other the general condition is well maintained even though there may be multiple bone lesions. 5. Sequestration is uncommon; but when it occurs it prevents the rapid healing that is usually observed after drainage. 6. The most important complication is suppurative arthritis, which may lead to total destruction of a joint. 7. It is probable that the lowered mortality from infantile septicaemia will be matched by a corresponding increase in the cases of acute osteomyelitis encountered in clinical practice.
Treatment of chronic osteomyelitis (COM) for young patients remains a challenge. Large bone deficiencies secondary to COM can be treated using induced membrane technique (IMT). However, it is unclear which type of bone graft is optimal. The goal of the study was to determine the clinical effectiveness of bone marrow concentrator modified allograft (BMCA) versus bone marrow aspirate mixed allograft (BMAA) for children with COM of long bones. Between January 2013 and December 2017, 26 young patients with COM were enrolled. Different bone grafts were applied to repair bone defects secondary to IMT procedure for infection eradication. Group BMCA was administered BMCA while Group BMAA was given BMAA. The results of this case-control study were retrospectively analyzed.Aims
Methods
1. Acute osteomyelitis is defined. 2. An analysis of 113 cases is given. 3. An effective programme of treatment was evolved from experience over a period of nine years. 4. Recommendations regarding a programme of treatment are given.
1. Sixty-seven patients with subacute haematogenous osteomyelitis are reported. 2. The benign nature of the disease is noted. 3. The clinical types of infection are reported, with regard to the site of the lesion. 4. The treatment is described.
1. Three cases of osteomyelitis of a metatarsal sesamoid bone are described. 2. The diagnosis should be considered in patients with acute pain under the first metatarsophalangeal joint, particularly if the temperature is elevated. 3. Failure ofdiagnosis may lead to persistent disability until sinus formation and sequestration dictate operative intervention. 4. Early antibiotic therapy may lead to resolution of the infection.
1. Five cases of Salmonella osteomyelitis in infants without red-cell sickling are reported. 2. All these cases occurred in children under eighteen months of age and within a period of five months of time, suggesting a seasonal incidence. 3. Only one strain of Salmonella was isolated–Salmonella typhimurium. 4. There was complete healing in four of the cases. 5. In one case there was destruction and complete absorption ofthe upper humeral epiphysis.
1. A series of 328 cases of acute haematogenous osteomyelitis in children is analysed. 2. In the first group ofseventy-seven cases from 1944 to 1950 penicillin gave excellent results. 3. After 1950 the disease took on new characteristics in terms of frequency, severity and age incidence, with the appearance of a staphylococcus resistant to penicillin: 251 cases are recorded from 1951 to 1960. 4. The importance of the early assessment ofthe disease into degrees of severity is emphasised as the surgeon's guide in his form of management. 5. The value of operative decompression is discussed. 6. The frequent and dire consequences of hip joint involvement are analysed and draillage of the hip joint is described.
This new blood test for infection is based on the phenomenon of leukergy in which white cells agglomerate in the peripheral blood of patients with inflammatory diseases. It was used in 26 patients with proven bone or joint infection and was positive in 25. The leukergy test was more accurate than the ESR, white cell count or blood culture. The percentage of cells agglomerated correlated with the clinical severity of the infection and the test detected reactivation of the septic process better than the other haematological tests. It is a rapid and inexpensive method which is useful in the diagnosis and management of bone and joint infections.
1. Continued follow-up of the 113 children with acute osteomyelitis previously reported and a study of a further thirty-eight proven cases has not changed our opinion that the correct management is rest and effective antibiotics. Operation should be undertaken only if pus is detectable clinically. 2. Bacteriological evidence shows that the flora causing this disease are less sensitive to benzylpenicillin than ten years ago and that a proportion are also likely to become resistant to methicillin and cloxacillin. 3. The most effective antibiotic combination used was fusidic acid and erythromycin. This lowered the failure rate to 10·5 per cent in thirty-eight proven cases. Two of the four failures were in haemophilus infections. No staphylococcal infection of a long bone became chronic, and all lesions were healed within three months of onset. 4. The duration of treatment (twenty-one days) and the method of splintage (removable plaster slabs) remained the same as in the previous series. 5. Careful watch must be kept on the incidence of haemophilus infections. If it rises, increasing the erythromycin or adding ampicillin may be necessary. 6. Use of the newer aqueous suspension of fusidic acid may lower the incidence of troublesome vomiting (12 per cent in this series). 7. Only 7 per cent of staphylococcus aureus infections in this hospital, and 17 per cent of such infections in our thirty-eight cases were sensitive to benzylpenicillin. It is thought that this drug has outlived its usefulness in osteomyelitis. 8. It is recommended that, on diagnosis, fusidic acid aqueous suspension 5 millilitres should be given three times a day to children aged one to five, and 10 millilitres twice a day for children aged six to twelve, with erythromycin stearate 30 milligrams per kilogram of body weight each day in divided doses.
1. In the treatment of chronic osteomyelitis the most troublesome factor is the infected bone cavity. This is seldom obliterated spontaneously by bone regeneration. The number of procedures designed to fill the cavity, since the beginning of the century, show how much it troubles the surgeon. 2. The use of bone grafts in the treatment of chronic osteomyelitis has been studied. One hundred and twenty cases are reviewed (the largest series in the literature), the follow-up being between two and ten years. The most common lesion was a bone cavity, with or without a sequestrum. 3. Treatment must include the removal of infected soft tissues as well as sclerosed bone, and must be done under appropriate antibiotic control. The value of cancellous bone grafts in filling infected cavities in the metaphysio-epiphysial regions is especially emphasised. 4. The results were gratifying, only four relapses occurring in 120 cases.
1. A primary subacute type of staphylococcal osteomyelitis has been described. It is the commonest form of osteomyelitis seen in East Africa, and the incidence appears to be increasing in Great Britain. 2. A review of the literature indicates that this is not a new disease but that in the past there has been some confusion in terminology. 3. The causative organism is a coagulase positive staphylococcus, but in a few instances a coagulase negative one has been isolated. The staphylococcus is thought to be of reduced virulence and in East Africa it is likely that the population has acquired an increased resistance to the staphylococcus. 4. Two radiologically distinct groups are recognised, depending on whether a bone abscess is present or not. In the first group there are two types of localised abscesses: the familiar Brodie's lesion and the less well recognised large bone abscess that occurs in the metaphysis of a long bone. While the pathology of the two types is similar, the radiological features are quite distinct. The lesions in the second group are characterised by extensive diaphysial changes, with or without metaphysial involvement, and an obvious abscess cannot usually be demonstrated. 5. The main clinical features are the long history, often weeks or months, before diagnosis; insignificant or absent general reaction to the infection and minimum physical signs. 6. Vertebral body osteomyelitis in adults is included because it generally presents as a subacute infection; the difficulties in distinguishing it from a tuberculous infection are outlined. 7. The most useful diagnostic aids are the staphylococcal antibody titres (especially in vertebral infections) and the erythrocyte sedimentation rate. A limited surgical exposure is usually required if the causative organism is to be isolated and empirical antibiotic therapy is to be avoided. The total and differential white blood count are so often normal in these patients that they are considered to be of no diagnostic value. 8. Curettage and local antibiotics together will cure the localised bone abscess. Other lesions may be effectively treated by systemic antibiotics alone, but in the later stages removal of sequestra and infected granulation tissue may be necessary. In this instance it is essential to make a planned incision and to cut a window in the bone large enough to expose the whole of the lesion; primary suture of the wound is advocated.
We reviewed all patients with a clinically infected foot ulcer attending a specialised neuropathic foot clinic. Neuropathy was confirmed by the inability to feel a 5.07 Semmes-Weinstein hair, areflexia and impaired vibration sense, as measured by a biothesiometer. Of 40 patients who attended the clinic over a two-year period, six with ischaemic ulcers were excluded. The remaining 34 had plain radiographs of the foot followed by a 99mTc-MDP bone scan. If the latter was positive, an 111In-labelled WBC scan was performed with planar and/or tomographic dual-isotope studies where appropriate. Bone and WBC scans were performed in 31 patients. In ten, isotope imaging showed infection localised to the soft tissues only and conservative treatment was successful in them all. Eighteen patients were treated surgically with excision of the involved bone, which was sent for culture and histological examination. Dual-isotope scans had a sensitivity of 93% and a specificity of 83%. 99mTc-MDP bone scans with the appropriate 111In-labelled WBC scans can reliably determine the site and extent of osteomyelitis in the neuropathic diabetic foot.
1. The dominant role of pathogenic staphylococci in surgical infections has been confirmed by positive isolations in 89·9 per cent of a wide variety of lesions in a hospital infective unit. Of 150 staphylococci isolated, 147 were sensitive to fusidic acid, two were slightly sensitive and only one was resistant. 2. Fusidic acid was administered as sodium fusidate to 100 patients with staphylococcal infections (including seventy-two with chronic post-traumatic osteomyelitis). Sterile swabs were achieved in seventy-seven of these patients and in the remaining twenty-three a change of flora was detected. 3. Bone samples were taken at operation from twenty-nine patients with chronic osteomyelitis who had been treated for at least five days with fusidic acid. Depending on dosage, the mean fusidic acid concentrations were 7·3 and 9·8 micrograms per gram. Corresponding levels in non-inflammatory bone samples from thirty-one patients were, depending on the duration of treatment, 12·3, 2l·3 and 25·4 micrograms per gram. The fusidic acid levels in cancellous bone were almost twice as high as those in compact bone. 4. The relevance of these findings to the use of fusidic acid therapy as an adjunct to surgical management of chronic osteomyelitis is discussed.
1. The treatment of twenty-nine consecutive patients suffering from chronic osteomyelitis is reviewed. With the advent of an antibiotic, Fucidin, which has the ability to penetrate in significant amounts into tissues carrying a poor blood supply, a more limited surgical procedure has become possible. 2. A successful outcome, as judged by primary healing, was achieved in 86 per cent of patients treated with a combination of surgery and Fucidin with penicillin. This compares favourably with the results achieved in a previous series in which more radical surgery was undertaken. 3. Although Fucidin has advanced the treatment of chronic osteomyelitis, it is still essential to use surgery as well. 4. Fucidin caused no toxic effects despite an average total dose of seventy to eighty grammes. Resistance of the staphylococcus developed
A case of salmonella osteitis of the spine is described. It is thought to be the first case reported due to the serotype
1. The three age types of acute haematogenous osteomyelitis are conditioned in their respective clinical features by the differing nature of their vascular bone pattern. 2. In the infant the condition causes severe and often permanent epiphysial damage and joint infection, a large involucrum but only transient damage to the shaft and metaphysis. 3. In the child the condition is responsible for extensive cortical damage with involucrum formation, but, except for some stimulation of growth, permanent damage to the growth cartilage and to joints is exceptional. Chronicity of the disease is rare if treatment has been effective. 4. In the adult acute osteomyelitis of the long bones is rare. It causes very frequent joint infection; the cortex is absorbed instead of sequestrating. The whole of the bone is invaded and frequently leaves chronic infection in the bone marrow. 5. The vascular characteristics of the bones in each age group and their relation to the onset of infection are described. 6. Some general directives for management based on these facts are suggested.
1. The clinical findings and results in seventeen patients under two years of age, suffering from acute osteomyelitis, have been studied and compared with forty-eight similar cases treated without penicillin. 2. The results in the penicillin-treated group were not greatly superior to those in the control group and did not justify the high hopes that have been entertained for penicillin as a certain cure for osteomyelitis.
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