Vertebral Fractures in Pediatric Suicidal Jumpers: A Retrospective Study with Epidemiological and Clinical Analysis before and after the COVID-19 Pandemic.

BACKGROUND: From the beginning of the COVID-19 pandemic, reports in the literature confirm a significant increase in suicide attempts in children and adolescents. At the Bambino Gesù Pediatric Hospital Emergency Department (Rome, Italy), there was a dramatic increase in suicidal jumpers. Many of these presented vertebral fractures. METHODS: This retrospective study includes all suicidal jumpers with vertebral fractures treated from April 2017 to March 2023. We collected and compared data from three years before to three years after the pandemic, analyzing vertebral fractures. RESULTS: From April 2019 to March 2020, 141 cases of suicide attempt arrived at the emergency department. Five of these were suicidal jumpers without vertebral fractures. From April 2020 to March 2023, 362 cases of suicide were hospitalized and 19 were suicidal jumpers; 12 reported vertebral fractures (mean age 14 years). Seven patients were treated by percutaneous pedicle fixation. Three patients needed an open spinal surgery by posterior approach. One case with cervical fractures was treated by Halo-Vest. CONCLUSIONS: This is the first report that shows a sharp increase in vertebral body fractures due to suicide jumping attempts in children and adolescents. This could be a new epidemiological phenomenon persisting or even increasing over time in the pediatric population as a consequence of the COVID-19 pandemic.

High Prevalence of Scoliosis in a Large Cohort of Patients with Prader-Willi Syndrome.

The characteristics of scoliosis were investigated in a large cohort of children and adults with Prader-Willi syndrome (PWS), analysing the role of age, gender, puberty, body mass index (BMI), genotype and growth hormone therapy (GHT) on its onset and severity. A retrospective cross-sectional study was performed in 180 patients with genetically confirmed PWS (96 females), aged 17.6 ± 12 years. Eighty-five subjects (47%) were obese. One hundred and fifty subjects (83.3%) were on GHT, while 30 patients had never been treated. Overall, 150 subjects (83.3%) were affected by scoliosis, 80.2% of children and adolescents and 87.8% of adults. A mild degree of scoliosis was observed in 58 patients (38.7%), moderate in 43 (28.7%) and severe in 49 (32.6%). Median age at diagnosis of scoliosis was 6.3 years, while the severe forms were diagnosed earlier (median age: 3.8 years). The cumulative probability at 5 years of age was equal to 0.403 and almost doubled at 15 years. No significant associations were found between scoliosis and genotype, gender, pubertal stage, GHT and BMI. A corset was prescribed to 75 subjects (50%) at a median age of 7.5 years, while 26 subjects (17.3%) underwent surgery at a median age of 13.1 years. Our data indicate that scoliosis is one of the major concerns for PWS patients that increases with age, and therefore suggest the need for regular systematic monitoring of spinal deformity from paediatric age.

Hemivertebra Resection and Spinal Arthrodesis by Single-Stage Posterior Approach in Congenital Scoliosis and Kyphoscoliosis: Results at 9.6 Years Mean Follow-up.

BACKGROUND: Congenital kyphoscoliosis due to hemivertebra is generally treated surgically because of high risk of curve progression and high risk of nervous system complications. Modern posterior access surgical techniques, including total hemivertebra resection, can completely correct deformity without additional anterior access surgeries. The purpose of this study was to evaluate midterm results of hemivertebra resection and spinal arthrodesis; the hypothesis was that it is a safe, effective, and reproducible procedure. MATERIALS AND METHODS: From 2006 to 2019, hemivertebra resection and instrumented spinal arthrodesis with pedicle screws was performed on 82 patients with congenital vertebral deformities (62 scoliosis and 20 kyphoscoliosis) by posterior approach. Mean age at surgery was 8.6 years, and 22 patients were under 10 years of age. After stabilization patients have been braced for a period from 3 to 5 months. RESULTS: Mean follow-up was 9.6 years (range 1.2-12.8 years); mean kyphosis curve after surgery was reduced to 20° Cobb; and mean scoliosis curve was reduced to 11° Cobb. We experienced no major complications (postsurgical infection, instrumentation failure, severe neurological impairment, severe blood loss) at latest follow-up . CONCLUSION: We strongly advocate one-time posterior hemivertebra resection and arthrodesis as the most suitable surgical procedure for congenital scoliosis due to hemivertebra. Posterior approach interventions with pedicle screws instrumentation are less invasive than combined anterior-posterior approach interventions. We think that posterior approach procedures can lead to excellent deformity correction in both frontal and sagittal views, optimal stability, and low risk of nervous injury. CLINICAL RELEVANCE: Congenital scoliosis treatment is one of the most challeging conditions a spine surgeon has to face. We advocate that a one-stage posterior approach for hemivertebrectomy and fusion is a reliable, safe tachnique, whom excellent results remain stable at a mid/long-term follow-up. LEVEL OF EVIDENCE: Level 4.

Spondylodiscitis in Children: A Retrospective Study and Comparison With Non-vertebral Osteomyelitis.

Objectives: The aim of this study is to provide new data on pediatrics spondylodiscitis for an optimal clinical management of this site-specific osteomyelitis. Methods: We reported 48 cases of pediatric spondylodiscitis and made three comparisons between: (1) tubercular and non-tubercular cases; (2) patients aged more or less than 5 years; (3) children with spondylodiscitis and 62 controls with non-vertebral osteomyelitis. Results: A higher rate of sequelae was reported in patients with tubercular spondylodiscitis, but no significant differences were noted at the cut-off of 5 years of age. Compared to non-vertebral osteomyelitis, pediatric spondylodiscitis affects younger children of both genders, usually presenting with afebrile back pain, and requiring longer time to admission, hospitalization, and antibiotic therapy. Conclusion: Pediatric spondylodiscitis is an insidious disease with a non-specific presentation in childhood and peculiarities of its own. However, when clinical remission is obtained by an early start of broad-spectrum antibiotics, prolonging the therapy does not improve, nor worsens, the outcome. Surgical management is mandatory in case of vertebral instability and neurological signs but can be avoided when the infection is promptly treated with antibiotic therapy.

SPINE20 A global advocacy group promoting evidence-based spine care of value.

PURPOSE: The Global Burden of Diseases (GBD) Studies have estimated that low back pain is one of the costliest ailments worldwide. Subsequent to GBD publications, leadership of the four largest global spine societies agreed to form SPINE20. This article introduces the concept of SPINE20, the recommendations, and the future of this global advocacy group linked to G20 annual summits. METHODS: The founders of SPINE20 advocacy group coordinated with G20 Saudi Arabia to conduct the SPINE20 summit in 2020. The summit was intended to promote evidence-based recommendations to use the most reliable information from high-level research. Eight areas of importance to mitigate spine disorders were identified through a voting process of the participating societies. Twelve recommendations were discussed and vetted. RESULTS: The areas of immediate concern were "Aging spine," "Future of spine care," "Spinal cord injuries," "Children and adolescent spine," "Spine-related disability," "Spine Educational Standards," "Patient safety," and "Burden on economy." Twelve recommendations were created and endorsed by 31/33 spine societies and 2 journals globally during a vetted process through the SPINE20.org website and during the virtual inaugural meeting November 10-11, 2020 held from the G20 platform. CONCLUSIONS: This is the first time that international spine societies have joined to support actions to mitigate the burden of spine disorders across the globe. SPINE20 seeks to change awareness and treatment of spine pain by supporting local projects that implement value-based practices with healthcare policies that are culturally sensitive based on scientific evidence.

Natural Course and Diagnosis of Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations.

Lumbar spinal stenosis (LSS) is defined as a degenerative disorder showing a narrowing of the spinal canal. The diagnosis is straightforward in cases with typical neurogenic claudication symptoms and unequivocal imaging findings. However, not all patients present with typical symptoms, and there is obviously no correlation between the severity of stenosis and clinical complaint. The radiologic diagnosis of LSS is widely discussed in the literature. The best diagnostic test for the diagnosis of LSS is magnetic resonance imaging (MRI). However, canal diameter measurements have not gained much consensus from radiologists, whereas qualitative measures, such as cerebrospinal fluid space obliteration, have achieved greater consensus. Instability can best be defined by standing lateral radiograms and flexion-extension radiograms. For cases showing typical neurogenic claudication symptoms and unequivocal imaging findings, the diagnosis is straightforward. However, not all patients present with typical symptoms, and there is obviously no correlation between the severity of stenosis (computed tomography and MRI) and clinical complaint. In fact, recent MRI studies have shown that mild-to-moderate stenosis can also be found in asymptomatic individuals. Routine electrophysiological tests such as lower extremity electromyography, nerve conduction studies, F-wave, and H-reflex are not helpful in the diagnosis and outcome prediction of LSS. The electrophysiological recordings are complementary to the neurologic examination and can provide confirmatory information in less obvious clinical complaints. However, in the absence of reliable evidence, imaging studies should be considered as a first-line diagnostic test in the diagnosis of degenerative LSS.

Lumbar Spine Osteoblastoma with Secondary Aneurysmal Bone Cyst Causing Severe Trunk Imbalance and Radiculopathy: A Case Report.

INTRODUCTION: Osteoblastomas are primary bone tumors, rarer than osteoid osteomas, and <10% of these lesions occurs in the spine. Aneurysmal bone cysts (ABCs) are rare, benign lesion of the bone and approximately 8-30% of ABCs arise in the spine, mostly in the thoracic and the lumbar regions. The association between them is quite rare in the general population. CASE REPORT: We report a case of a 14-year-old boy, soccer player, with an osteoblastoma of the left posterior neural arc of L2 and a secondary aneurismal bone cyst compressing the left L2 nerve root, causing severe antalgic scoliosis and back pain with radiculopathy. A complete surgical excision with radicular decompression has been performed, and the histologic examination confirmed the diagnostic hypothesis (osteoblastoma + ABC). At 6 months follow-up, the patient presented a complete resolution of symptoms, but the trunk imbalance was not completely resolved. CONCLUSION: Spine localization of osteoblastoma + ABC is rare and its diagnosis and treatment are often challenging. Complete surgical excision seems to be confirmed as the gold standard of treatment, but the option of instrumented arthrodesis should be carefully evaluated.

Conservative versus surgical treatment of Gartland type 2 supracondylar humeral fractures: What can help us choosing?

BACKGROUND: Pediatric supracondylar humeral fractures (PSHF) are most common elbow fractures among children and adolescents. While there is substantial agreement on treating type 1 and type 3 fractures (conservatively and surgically, respectively), the debate on optimal treatment of Gartland type 2 fractures is still open.We wanted to review our cases, analyzing outcomes and seeking for parameters that could help surgeons treating these injuries. METHODS: We retrospectively reviewed 41 patients treated with reduction and casting (group A) and matched to 38 patients treated with closed reduction and percutaneous pining (CRPP, group B) for Gartland type 2 fractures between 2009 and 2013. At a mean follow-up of more than 6 years patients were analyzed by an accurate clinical exam and evaluation scales. Radiographic parameters at time of cast or pins removal were studied too. RESULTS: There were no statistically significant differences in clinical exam and evaluation scales between groups. Two patients in group A developed a cubitus varus deformity and one patient in group B had a superficial pin-tract infection. Baumann angle (BA) was out of normal range in two cases of conservative group and anterior humeral line (AHL) bisected capitellum in 42.1% of patients in group A and 73.2% in group B (p < .05). CONCLUSION: It is reasonable to expect satisfactory outcomes both after conservative and surgical treatment of type 2 fractures, if cornerstones of both treatments are applied. Parameters that should be focused are probably two: complications (2 cases of cubitus varus in group A versus one superificial pin-tract infections in group B) and the better trend in surgical group in regards to loss of flexion and hyperextension of the affected elbow, likely related to the other notable datum, that is the percentage of cases in which AHL bisects capitellum. We think that, in absence of vascolonervous lesions and important swelling, BA and AHL are the most important parameters that can help us choosing the optimal treatment, as clarified in the algorithm we developed. LEVEL OF EVIDENCE: Level III - retrospective comparative study.

Spine challenges in mucopolysaccharidosis.

PURPOSE: Mucopolysaccharidosis (MPS) are rare inherited metabolic diseases, causing lysosomal storage of mucopolysaccharides; clinical presentation involves skeletal system and particularly the spine. Anomalies include developing kyphosis at thoracolumbar junction, that can causes nervous symptoms, and dens hypoplasia with associated atlantoaxial subluxation that can cause myelopathy. We present our experience in the treatment of spine pathology in MPS. METHODS: Medical treatments of MPS seem to have little impact on spine disease: treatment of cervical instability often includes surgical decompression and stabilization, as in patient MPS1 that we present, while thoracic lumbar kyphosis is treated by bracing and, in severe cases, with surgery. Bracing is more effective in kyphosis under 40° Cobb. Our surgical cases with thoracic lumbar kyphosis over 40° Cobb, treatment include the first one ever described by only posterior approach with vertebrectomy in MPS and a case of lateral costo-transverse approach instrumented correction. RESULTS: Surgical patients had no major complications after surgery and CT scan at follow-up showed complete fusion without loss of correction, even if in a cervical case we used an adult rigid instrumentation in a four year-and-six month-old girl (11 years follow-up) and in thoracic lumbar kyphosis case treated by vertebrectomy due to diminutive anatomy we positioned interbody cage in suboptimal position. CONCLUSIONS: Bracing is a viable treatment strategy in thoracic lumbar kyphosis and can obtain good clinical results at medium terms follow-up even if kyphosis deformity remains in radiographs. Surgical treatment is effective in severe evolving cases both at cervical and thoracic lumbar level, main difficulties arose from unavailability of dedicated instrumentation in very young patient, as even smallest devices available are often too big.

Adolescent idiopathic scoliosis correction by instrumented vertebral arthrodesis with autologous bone graft from local harvesting without bone substitute use: results with mean 3 year follow-up.

PURPOSE: Bone substitutes' advantage is enhancing arthrodesis biologic support without further autologous bone graft harvested from other skeleton sites, as from posterior iliac crests; however, in our experience, bone substitutes' integration is often incomplete. METHODS: From 2012 to 2017, we operated 108 patients by posterior instrumented vertebral arthrodesis in adolescent idiopathic scoliosis (AIS) correction, mean main curve 80° Cobb, and mean age 12 years and 6 months, with all pedicle screws instrumentation in main curve/curves area and hooks at upper tip of implant; bone graft has been harvested only at vertebral level, without bone substitutes or autologous graft from other patient sites or allogenic bone graft. We matched this group with 98 patients previously operated in which we used calcium triphosphate. RESULTS: At 3 year mean follow-up, all patients in group treated with autologous bone graft only have complete and stable arthrodesis without loss of correction (mean curve 27° Cobb) or instrumentation failure. At 6 year mean follow-up in the group treated with autologous bone graft augmented by calcium triphosphate, 96 patients have stable arthrodesis without loss of correction (mean curve 24°), 1 case has implant break, and 1 case has 8° Cobb loss of correction. CONCLUSION: Bone substitutes are a further cost in arthrodesis surgery and suboptimal integration leaves foreign bodies on vertebras. Our experience shows that all pedicle screw instrumentation and bracing after surgery obtain stable correction showing in time a solid arthrodesis with autologous bone only, harvested at local site, without bone substitutes or further bone graft.

Posterior approach lumbar and thoracolumbar hemivertebra resection in congenital scoliosis in children under 10 years of age: results with 3 years mean follow up.

INTRODUCTION: The authors present 15 cases of congenital scoliosis with lumbar or thoracolumbar hemivertebra in children under 10 years of age (mean age at the time of surgery was 5.5 years). Patients were treated by posterior hemivertebra resection and pedicle screws two levels stabilization or three or more levels stabilization in the case of deformity above or under hemivertebra or for severe curve deformities. MATERIALS AND METHODS: All operated patients had worsening curves; mean follow up was 40 months. The mean scoliosis curve value was 44° Cobb, and reduced to a mean 11° Cobb after surgery. The mean segmental kyphosis value was 19.7° Cobb, and reduced to a mean -1.8° Cobb after surgery. We did not consider total dorsal kyphosis value as all hemivertebras treated were at lumbar or thoracic lumbar level. No major complications emerged (infections, instrumentation mobilization or failure, neurological or vascular impairment) and only one pedicle fracture occurred. RESULTS: Our findings show that the hemivertebra resection with posterior approach instrumentation is an effective procedure, which has led to significant advances in congenital deformity control, which include excellent frontal and sagittal correction, excellent stability, short segment arthrodesis, low neurological impairment risk, and no necessity for further anterior surgery. CONCLUSION: Surgery should be considered as soon as possible in order to avoid severe deformity and the use of long segment arthrodesis. The youngest patient we treated, with a completed dossier at the end the follow up was 24 months old at the time of surgery; the youngest patient treated by this procedure was 18 months old at the time of surgery.

Treatment of severe scoliosis with posterior-only approach arthrodesis and all-pedicle screw instrumentation.

PURPOSE: Posterior-only approach arthrodesis by all-pedicle screw instrumentation has a correction rate similar to correction obtained by traditional combined anterior/posterior approach surgery and avoids the complications associated with the thoracic approach. METHODS: We treated 25 patients, with a mean age 16.5 years, with severe adolescent idiopathic scoliosis by posterior-only approach using all-screw instrumentation arthrodesis. Mean scoliosis curve in Cobb degrees was 95° Cobb. All cases were treated by the same senior surgeon, by free hand technique, without intraoperative neurophysiologic monitoring and spine navigation aids. RESULTS: Mean scoliosis curve after surgery was 37° Cobb. Mean follow-up was 4 years. No perioperative complications, curve progression or arthrodesis malunion were reported at the follow-up. CONCLUSIONS: Posterior spinal fusion with pedicle screw-only instrumentation obtains a good and stable correction of severe scoliosis; compared to hybrid instrumentation, it allows a greater coronal correction of the deformity and less correction loss at the follow-up.

AIS and spondylolisthesis.

INTRODUCTION: The association of scoliosis and spondylolisthesis is well documented in literature; the nature and modalities of the relationship of the two pathologies are variable and not always clear. Also, etiologic particulars of scoliosis associated with spondylolisthesis are not well defined, even in cases where scoliosis is called idiopathic. In this paper, we review previous literature and discuss the different aspects of the mutual relationship of scoliosis and spondylolisthesis in the adolescent age. MATERIALS AND METHODS: It is a common notion that the highest occurrence of scoliosis associated with spondylolisthesis is at the lumbar level, both in adolescent and in adult patients. It is probable that the scoliosis that is more heavily determined by the presence of spondylolisthesis is at the lumbar level and presents curve angle lower than 15° Cobb and mild rotation. The scoliosis with curve value over 15° Cobb that is present at the lumbar level in association with spondylolisthesis probably is not prominently due to spondylolisthesis: in these cases, spondylolisthesis is probably only partially responsible for scoliosis progression with a spasm mechanism and/or due to rotation of slipping "olisthetic" vertebra. DISCUSSION: We think that the two pathologies should be treated separately, as stated by many other authors, but we would highlight the concept that, whatever be the scoliosis curve origin, spasm, olisthetic or mixed together, this origin has no influence on treatment. The curves should be considered, for all practical effects, as so-called idiopathic scoliosis. We think that generally patient care should be addressed to treat only spondylolisthesis or only scoliosis, if it is necessary on the basis of clinical findings and therapeutic indications of the isolated pathologies, completely separating the two diseases treatments. CONCLUSIONS: Scoliosis should be considered as an independent disease; only in the case of scoliosis curve progression over time, associated scoliosis must be treated, according to therapeutic principles of the care of any so-called idiopathic scoliosis of similar magnitude, and a similar approach must be applied in the case of spondylolisthesis progression or painful spondylolisthesis.

Free-hand pedicle screws insertion technique in the treatment of 120 consecutive scoliosis cases operated without use of intraoperative neurophysiological monitoring.

PURPOSE: We present 120 patients (37 males, 83 females) affected by thoracic lumbar scoliosis, treated by posterior instrumented arthrodesis with the insertion of pedicle screws by "free hand technique", without any image guided system, radioscopy use during insertion or intraoperative neurophysiological monitoring. METHODS: Seventy-two (60%) patients have been treated by hybrid instrumentation with lumbar and thoracic screws, hooks and wires at thoracic levels, while the remaining 48 (40%) patients have used only lumbar and thoracic pedicle screws. Mean Cobb grades value of the main scoliotic curve was 73° before surgery in patients treated by hybrid instrumentation, reduced to 37.5° after surgery. In patients treated only by screws, mean Cobb grades value of the main scoliotic curve was 65°, reduced to 16° after surgery. RESULTS: Minimum follow up has been 3 years; mean patient age at surgery was 15 years and 4 months. We placed a total number of 1,004 pedicle screws, 487 of which at thoracic level. In 12 patients (10%) a total number of 20 screws were misplaced at postoperatory exam, without any clinical complication for the patients or consequences on the arthrodesis or on maintaining the correction of the curve. CONCLUSIONS: In our experience pedicle screws is the method that leads to best correction and balance on vertebral bodies, with best results at distance concerning correction maintaining. Our experience shows that even at thoracic level, pedicle screws insertion by free-hand technique is safe and reliable.

Cervical fixation in the pediatric patient: our experience.

The surgical management of cervical instability in children is a challenging issue. Although the indications for internal fixation are similar to those for adults, accurate pre-surgery study and sharp surgical techniques are necessary because of the size of such patients' anatomy, their peculiar tissue biology and the wide spectrum of diseases requiring cervical fusion. Our case study is made up of 31 patients, 15 male and 16 female, with an average age of 7 years and 6 months (2 years and 6 months to 18 years) who underwent cervical fusion for instability. Their physical condition presented various different pathologies ranging from congenital deformity, systemic skeletal disease, tumors, trauma, post-surgery instability. We performed occipito-cervical fusion in 11 cases, 5 of which involved stabilization at the cranium-vertebral junction. We used instrumentation in 13 cases (3 sublaminar wiring, 10 rigid adult instrumentation). We used rigid adult instrumentation in three patients under 10 years of age, treated by rod, occipital screws and sublaminar hook instrumentation in steel C0-C2 (9-year-old male, affected by os odontoideum in Down's syndrome; male of 7 years and 10 months, affected by os odontoideum in Down's syndrome; female of 4 years and 6 months with occipito-cervical stenosis and C0-C2 instability in Hurler's syndrome). We operated on two patients under 3 years of age, using sublaminar wiring with bone precursors and allograft at level C0-C2 (one of these was a 30-month-old male with post-traumatic instability C0-C2, while the other was a 17-month-old male with C0-C2 instability in Larsen's syndrome). The average follow-up age was 7 years and 1 month (between 1 and 18 years). Cervical fusion was assessed by X-ray examinations at 4th and 12th weeks and at 6th and 12th months after surgery. Where implants could allow, RMN examination was performed at 1st month after surgery. In the other cases, in which implants do not allow RMN to be performed, CT scan and standard X-rays were carried out, and new X-rays were performed every other year. We experienced two cases of sublaminar wiring rupture without impairment of bone fusion. No patient suffered major complications (infection and osteomyelitis, rigid instrumentation mobilization, incomplete fusion with instability, neurologic impairment, insufficient cervical spine range of movement to cope with everyday life activities, cervical pain). Even though most authors still indicate that rigid instrumentation should be performed in cases over 10 years of age and sublaminar wiring in cases over 3 years of age, our findings demonstrate that this age limit can be lowered. We have treated children under 10 years of age by rigid adult instrumentation and under 36 months of age by wiring. The anatomic size of the patient is the most important factor in determining the use of instrument arthrodesis to treat pediatric cervical spine instability. Although not easy, it is possible and preferable in many cases to adapt fixation to child cervical spine even in very young patients.

Aneurysmal bone cysts: treatment with direct percutaneous Ethibloc injection: long-term results.

PURPOSE: To assess the efficacy and long-term results of Ethibloc treatment in aneurysmal bone cysts (ABC). METHODS: Thirteen patients with ABC were treated with direct percutaneous Ethibloc injection. Four patients had only one injection and the other nine patients from two to four injections. No severe complications were observed; in two patients a local leakage of Ethibloc from the cyst into the soft tissues occurred but it was temporary and the consequent inflammation self-healed without residua and sequelae. Imaging follow-up lasted from 6 to 67 months and included conventional radiology (CR) and magnetic resonance imaging (MRI), both used in the presurgical phase. RESULTS AND CONCLUSIONS: All images demonstrated a remarkable shrinkage of the cystic lesion and bone cortex thickening. In all patients, circumscribed areas of lucency persisted at radiography, corresponding to residual cystic areas without fluid-fluid levels at MRI. Pain, which was present in all the patients before treatment, was relieved within a month. According to our experience, direct percutaneous Ethibloc injection is effective in the treatment of ABC and can be recommended as the first-choice treatment. Due to its higher sensitivity MRI must be included either in the pretreatment phase to study the multilocular structure or in the imaging follow-up to evaluate the efficacy of Ethibloc in persistently non-responsive areas.