Search

High efficacy in terms of protection from severe COVID-19 has been demonstrated for several SARS-CoV-2 vaccines. However, patients with compromised immune status develop a weaker and less stable immune response to vaccination. Strong immune response may not always translate into clinical benefit, therefore it is important to synthesise evidence on modified schemes and types of vaccination in these population subgroups for guiding health decisions. As the literature on COVID-19 vaccines continues to expand, we aimed to scope the literature on multiple subgroups to subsequently decide on the most relevant research questions to be answered by systematic reviews.To provide an overview of the availability of existing literature on immune response and long-term clinical outcomes after COVID-19 vaccination, and to map this evidence according to the examined populations, specific vaccines, immunity parameters, and their way of determining relevant long-term outcomes and the availability of mapping between immune reactivity and relevant outcomes.We searched the Cochrane COVID-19 Study Register, the Web of Science Core Collection, and the World Health Organization COVID-19 Global literature on coronavirus disease on 6 December 2021. SELECTION CRITERIA: We included studies that published results on immunity outcomes after vaccination with BNT162b2, mRNA-1273, AZD1222, Ad26.COV2.S, Sputnik V or Sputnik Light, BBIBP-CorV, or CoronaVac on predefined vulnerable subgroups such as people with malignancies, transplant recipients, people undergoing renal replacement therapy, and people with immune disorders, as well as pregnant and breastfeeding women, and children. We included studies if they had at least 100 participants (not considering healthy control groups); we excluded case studies and case series.We extracted data independently and in duplicate onto an online data extraction form. Data were represented as tables and as online maps to show the frequency of studies for each item. We mapped the data according to study design, country of participant origin, patient comorbidity subgroup, intervention, outcome domains (clinical, safety, immunogenicity), and outcomes. MAIN RESULTS: Out of 25,452 identified records, 318 studies with a total of more than 5 million participants met our eligibility criteria and were included in the review. Participants were recruited mainly from high-income countries between January 2020 and 31 October 2021 (282/318); the majority of studies included adult participants (297/318). Haematological malignancies were the most commonly examined comorbidity group (N = 54), followed by solid tumours (N = 47), dialysis (N = 48), kidney transplant (N = 43), and rheumatic diseases (N = 28, 17, and 15 for mixed diseases, multiple sclerosis, and inflammatory bowel disease, respectively). Thirty-one studies included pregnant or breastfeeding women. The most commonly administered vaccine was BNT162b2 (N = 283), followed by mRNA-1273 (N = 153), AZD1222 (N = 66), Ad26.COV2.S (N = 42), BBIBP-CorV (N = 15), CoronaVac (N = 14), and Sputnik V (N = 5; no studies were identified for Sputnik Light). Most studies reported outcomes after regular vaccination scheme. The majority of studies focused on immunogenicity outcomes, especially seroconversion based on binding antibody measurements and immunoglobulin G (IgG) titres (N = 179 and 175, respectively). Adverse events and serious adverse events were reported in 126 and 54 studies, whilst SARS-CoV-2 infection irrespective of severity was reported in 80 studies. Mortality due to SARS-CoV-2 infection was reported in 36 studies. Please refer to our evidence gap maps for more detailed information.Up to 6 December 2021, the majority of studies examined data on mRNA vaccines administered as standard vaccination schemes (two doses approximately four to eight weeks apart) that report on immunogenicity parameters or adverse events. Clinical outcomes were less commonly reported, and if so, were often reported as a secondary outcome observed in seroconversion or immunoglobulin titre studies. As informed by this scoping review, two effectiveness reviews (on haematological malignancies and kidney transplant recipients) are currently being conducted.

Background Monoclonal antibodies (mAbs) are laboratory‐produced molecules derived from the B cells of an infected host. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID‐19). Objectives To assess the effectiveness and safety of SARS‐CoV‐2‐neutralising mAbs for treating patients with COVID‐19, compared to an active comparator, placebo, or no intervention. To maintain the currency of the evidence, we will use a living systematic review approach. A secondary objective is to track newly developed SARS‐CoV‐2‐targeting mAbs from first tests in humans onwards. Search methods We searched MEDLINE, Embase, the Cochrane COVID‐19 Study Register, and three other databases on 17 June 2021. We also checked references, searched citations, and contacted study authors to identify additional studies. Between submission and publication, we conducted a shortened randomised controlled trial (RCT)‐only search on 30 July 2021. Selection criteria We included studies that evaluated SARS‐CoV‐2‐neutralising mAbs, alone or combined, compared to an active comparator, placebo, or no intervention, to treat people with COVID‐19. We excluded studies on prophylactic use of SARS‐CoV‐2‐neutralising mAbs. Data collection and analysis Two authors independently assessed search results, extracted data, and assessed risk of bias using the Cochrane risk of bias tool (RoB2). Prioritised outcomes were all‐cause mortality by days 30 and 60, clinical progression, quality of life, admission to hospital, adverse events (AEs), and serious adverse events (SAEs). We rated the certainty of evidence using GRADE. Main results We identified six RCTs that provided results from 17,495 participants with planned completion dates between July 2021 and December 2031. Target sample sizes varied from 1020 to 10,000 participants. Average age was 42 to 53 years across four studies of non‐hospitalised participants, and 61 years in two studies of hospitalised participants. Non‐hospitalised individuals with COVID‐19 Four studies evaluated single agents bamlanivimab (N = 465), sotrovimab (N = 868), regdanvimab (N = 307), and combinations of bamlanivimab/etesevimab (N = 1035), and casirivimab/imdevimab (N = 799). We did not identify data for mortality at 60 days or quality of life. Our certainty of the evidence is low for all outcomes due to too few events (very serious imprecision). Bamlanivimab compared to placebo No deaths occurred in the study by day 29. There were nine people admitted to hospital by day 29 out of 156 in the placebo group compared with one out of 101 in the group treated with 0.7 g bamlanivimab (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.02 to 1.33), 2 from 107 in the group treated with 2.8 g (RR 0.32, 95% CI 0.07 to 1.47) and 2 from 101 in the group treated with 7.0 g (RR 0.34, 95% CI 0.08 to 1.56). Treatment with 0.7 g, 2.8 g and 7.0 g bamlanivimab may have similar rates of AEs as placebo (RR 0.99, 95% CI 0.66 to 1.50; RR 0.90, 95% CI 0.59 to 1.38; RR 0.81, 95% CI 0.52 to 1.27). The effect on SAEs is uncertain. Clinical progression/improvement of symptoms or development of severe symptoms were not reported. Bamlanivimab/etesevimab compared to placebo There were 10 deaths in the placebo group and none in bamlanivimab/etesevimab group by day 30 (RR 0.05, 95% CI 0.00 to 0.81). Bamlanivimab/etesevimab may decrease hospital admission by day 29 (RR 0.30, 95% CI 0.16 to 0.59), may result in a slight increase in any grade AEs (RR 1.15, 95% CI 0.83 to 1.59) and may increase SAEs (RR 1.40, 95% CI 0.45 to 4.37). Clinical progression/improvement of symptoms or development of severe symptoms were not reported. Casirivimab/imdevimab compared to placebo Casirivimab/imdevimab may reduce hospital admissions or death (2.4 g: RR 0.43, 95% CI 0.08 to 2.19; 8.0 g: RR 0.21, 95% CI 0.02 to 1.79). We are uncertain of the effect on grades 3‐4 AEs (2.4 g: RR 0.76, 95% CI 0.17 to 3.37; 8.0 g: RR 0.50, 95% CI 0.09 to 2.73) and SAEs (2.4 g: RR 0.68, 95% CI 0.19 to 2.37; 8.0 g: RR 0.34, 95% CI 0.07 to 1.65). Mortality by day 30 and clinical progression/improvement of symptoms or development of severe symptoms were not reported. Sotrovimab compared to placebo We are uncertain whether sotrovimab has an effect on mortality (RR 0.33, 95% CI 0.01 to 8.18) and invasive mechanical ventilation (IMV) requirement or death (RR 0.14, 95% CI 0.01 to 2.76). Treatment with sotrovimab may reduce the number of participants with oxygen requirement (RR 0.11, 95 % CI 0.02 to 0.45), hospital admission or death by day 30 (RR 0.14, 95% CI 0.04 to 0.48), grades 3‐4 AEs (RR 0.26, 95% CI 0.12 to 0.60), SAEs (RR 0.27, 95% CI 0.12 to 0.63) and may have little or no effect on any grade AEs (RR 0.87, 95% CI 0.66 to 1.16). Regdanvimab compared to placebo Treatment with either dose (40 or 80 mg/kg) compared with placebo may decrease hospital admissions or death (RR 0.45, 95% CI 0.14 to 1.42; RR 0.56, 95% CI 0.19 to 1.60, 206 participants), but may increase grades 3‐4 AEs (RR 2.62, 95% CI 0.52 to 13.12; RR 2.00, 95% CI 0.37 to 10.70). 80 mg/kg may reduce any grade AEs (RR 0.79, 95% CI 0.52 to 1.22) but 40 mg/kg may have little to no effect (RR 0.96, 95% CI 0.64 to 1.43). There were too few events to allow meaningful judgment for the outcomes mortality by 30 days, IMV requirement, and SAEs. Hospitalised individuals with COVID‐19 Two studies evaluating bamlanivimab as a single agent (N = 314) and casirivimab/imdevimab as a combination therapy (N = 9785) were included. Bamlanivimab compared to placebo We are uncertain whether bamlanivimab has an effect on mortality by day 30 (RR 1.39, 95% CI 0.40 to 4.83) and SAEs by day 28 (RR 0.93, 95% CI 0.27 to 3.14). Bamlanivimab may have little to no effect on time to hospital discharge (HR 0.97, 95% CI 0.78 to 1.20) and mortality by day 90 (HR 1.09, 95% CI 0.49 to 2.43). The effect of bamlanivimab on the development of severe symptoms at day 5 (RR 1.17, 95% CI 0.75 to 1.85) is uncertain. Bamlanivimab may increase grades 3‐4 AEs at day 28 (RR 1.27, 95% CI 0.81 to 1.98). We assessed the evidence as low certainty for all outcomes due to serious imprecision, and very low certainty for severe symptoms because of additional concerns about indirectness. Casirivimab/imdevimab with usual care compared to usual care alone Treatment with casirivimab/imdevimab compared to usual care probably has little or no effect on mortality by day 30 (RR 0.94, 95% CI 0.87 to 1.02), IMV requirement or death (RR 0.96, 95% CI 0.90 to 1.04), nor alive at hospital discharge by day 30 (RR 1.01, 95% CI 0.98 to 1.04). We assessed the evidence as moderate certainty due to study limitations (lack of blinding). AEs and SAEs were not reported. Authors' conclusions The evidence for each comparison is based on single studies. None of these measured quality of life. Our certainty in the evidence for all non‐hospitalised individuals is low, and for hospitalised individuals is very low to moderate. We consider the current evidence insufficient to draw meaningful conclusions regarding treatment with SARS‐CoV‐2‐neutralising mAbs. Further studies and long‐term data from the existing studies are needed to confirm or refute these initial findings, and to understand how the emergence of SARS‐CoV‐2 variants may impact the effectiveness of SARS‐CoV‐2‐neutralising mAbs. Publication of the 36 ongoing studies may resolve uncertainties about the effectiveness and safety of SARS‐CoV‐2‐neutralising mAbs for the treatment of COVID‐19 and possible subgroup differences.

BACKGROUND: Monoclonal antibodies (mAbs) are laboratory‐produced molecules derived from the B cells of an infected host. They are being investigated as potential prophylaxis to prevent coronavirus disease 2019 (COVID‐19). OBJECTIVES: To assess the effects of SARS‐CoV‐2‐neutralising mAbs, including mAb fragments, to prevent infection with SARS‐CoV‐2 causing COVID‐19; and to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS: We searched the Cochrane COVID‐19 Study Register, MEDLINE, Embase, and three other databases on 27 April 2022. We checked references, searched citations, and contacted study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated SARS‐CoV‐2‐neutralising mAbs, including mAb fragments, alone or combined, versus an active comparator, placebo, or no intervention, for pre‐exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) of COVID‐19. We excluded studies of SARS‐CoV‐2‐neutralising mAbs to treat COVID‐19, as these are part of another review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed search results, extracted data, and assessed risk of bias using Cochrane RoB 2. Prioritised outcomes were infection with SARS‐CoV‐2, development of clinical COVID‐19 symptoms, all‐cause mortality, admission to hospital, quality of life, adverse events (AEs), and serious adverse events (SAEs). We rated the certainty of evidence using GRADE. MAIN RESULTS: We included four RCTs of 9749 participants who were previously uninfected and unvaccinated at baseline. Median age was 42 to 76 years. Around 20% to 77.5% of participants in the PrEP studies and 35% to 100% in the PEP studies had at least one risk factor for severe COVID‐19. At baseline, 72.8% to 82.2% were SARS‐CoV‐2 antibody seronegative. We identified four ongoing studies, and two studies awaiting classification. Pre‐exposure prophylaxis Tixagevimab/cilgavimab versus placebo One study evaluated tixagevimab/cilgavimab versus placebo in participants exposed to SARS‐CoV‐2 wild‐type, Alpha, Beta, and Delta variant. About 39.3% of participants were censored for efficacy due to unblinding and 13.8% due to vaccination. Within six months, tixagevimab/cilgavimab probably decreases infection with SARS‐CoV‐2 (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.29 to 0.70; 4685 participants; moderate‐certainty evidence), decreases development of clinical COVID‐19 symptoms (RR 0.18, 95% CI 0.09 to 0.35; 5172 participants; high‐certainty evidence), and may decrease admission to hospital (RR 0.03, 95% CI 0 to 0.59; 5197 participants; low‐certainty evidence). Tixagevimab/cilgavimab may result in little to no difference on mortality within six months, all‐grade AEs, and SAEs (low‐certainty evidence). Quality of life was not reported. Casirivimab/imdevimab versus placebo One study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS‐CoV‐2 wild‐type, Alpha, and Delta variant. About 36.5% of participants opted for SARS‐CoV‐2 vaccination and had a mean of 66.1 days between last dose of intervention and vaccination. Within six months, casirivimab/imdevimab may decrease infection with SARS‐CoV‐2 (RR 0.01, 95% CI 0 to 0.14; 825 seronegative participants; low‐certainty evidence) and may decrease development of clinical COVID‐19 symptoms (RR 0.02, 95% CI 0 to 0.27; 969 participants; low‐certainty evidence). We are uncertain whether casirivimab/imdevimab affects mortality regardless of the SARS‐CoV‐2 antibody serostatus. Casirivimab/imdevimab may increase all‐grade AEs slightly (RR 1.14, 95% CI 0.98 to 1.31; 969 participants; low‐certainty evidence). The evidence is very uncertain about the effects on grade 3 to 4 AEs and SAEs within six months. Admission to hospital and quality of life were not reported. Postexposure prophylaxis Bamlanivimab versus placebo One study evaluated bamlanivimab versus placebo in participants who may have been exposed to SARS‐CoV‐2 wild‐type. Bamlanivimab probably decreases infection with SARS‐CoV‐2 versus placebo by day 29 (RR 0.76, 95% CI 0.59 to 0.98; 966 participants; moderate‐certainty evidence), may result in little to no difference on all‐cause mortality by day 60 (R 0.83, 95% CI 0.25 to 2.70; 966 participants; low‐certainty evidence), may increase all‐grade AEs by week eight (RR 1.12, 95% CI 0.86 to 1.46; 966 participants; low‐certainty evidence), and may increase slightly SAEs (RR 1.46, 95% CI 0.73 to 2.91; 966 participants; low‐certainty evidence). Development of clinical COVID‐19 symptoms, admission to hospital within 30 days, and quality of life were not reported. Casirivimab/imdevimab versus placebo One study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS‐CoV‐2 wild‐type, Alpha, and potentially, but less likely to Delta variant. Within 30 days, casirivimab/imdevimab decreases infection with SARS‐CoV‐2 (RR 0.34, 95% CI 0.23 to 0.48; 1505 participants; high‐certainty evidence), development of clinical COVID‐19 symptoms (broad‐term definition) (RR 0.19, 95% CI 0.10 to 0.35; 1505 participants; high‐certainty evidence), may result in little to no difference on mortality (RR 3.00, 95% CI 0.12 to 73.43; 1505 participants; low‐certainty evidence), and may result in little to no difference in admission to hospital. Casirivimab/imdevimab may slightly decrease grade 3 to 4 AEs (RR 0.50, 95% CI 0.24 to 1.02; 2617 participants; low‐certainty evidence), decreases all‐grade AEs (RR 0.70, 95% CI 0.61 to 0.80; 2617 participants; high‐certainty evidence), and may result in little to no difference on SAEs in participants regardless of SARS‐CoV‐2 antibody serostatus. Quality of life was not reported. AUTHORS' CONCLUSIONS: For PrEP, there is a decrease in development of clinical COVID‐19 symptoms (high certainty), infection with SARS‐CoV‐2 (moderate certainty), and admission to hospital (low certainty) with tixagevimab/cilgavimab. There is low certainty of a decrease in infection with SARS‐CoV‐2, and development of clinical COVID‐19 symptoms; and a higher rate for all‐grade AEs with casirivimab/imdevimab. For PEP, there is moderate certainty of a decrease in infection with SARS‐CoV‐2 and low certainty for a higher rate for all‐grade AEs with bamlanivimab. There is high certainty of a decrease in infection with SARS‐CoV‐2, development of clinical COVID‐19 symptoms, and a higher rate for all‐grade AEs with casirivimab/imdevimab. Although there is high‐to‐moderate certainty evidence for some outcomes, it is insufficient to draw meaningful conclusions. These findings only apply to people unvaccinated against COVID‐19. They are only applicable to the variants prevailing during the study and not other variants (e.g. Omicron). In vitro, tixagevimab/cilgavimab is effective against Omicron, but there are no clinical data. Bamlanivimab and casirivimab/imdevimab are ineffective against Omicron in vitro. Further studies are needed and publication of four ongoing studies may resolve the uncertainties.

This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: To evaluate the duration of natural antibody‐related immunity after SARS‐CoV‐2 infection, measured as IgG, using a living systematic review approach. INVESTIGATION OF SOURCES OF HETEROGENEITY BETWEEN STUDIES: IgG measurements may be dependent on the respective test used; therefore we will completely separate serological assays from neutralisation assays. We will investigate whether studies that differ regarding the specific type of test, disease severity, age, gender, comorbidities, or virus mutation have varying IgG outcomes.

The purpose of this chapter is to describe the cervical approach from C2 to T1 and the surgical technique to perform a safe corporectomy and fusion.

Resume Introduction Le traitement de la stenose lombaire represente aujourd’hui un enjeu de sante publique. Les dispositifs inter epineux mis en place par voie mini-invasive representeraient une alternative therapeutique a la technique classique de decompression ± arthrodese intervertebrale. En raison d’un manque de donnees biomecaniques et cliniques, leurs indications de pose ne sont pas clairement etablies. Le but de ce travail est de caracteriser l’effet d’implants inter epineux disposes a l’etage L4-L5 sur la surface des foramens intervertebraux a l’etage implante et aux etages adjacents en flexion et en extension. Materiel et methode L’etude a necessite la preparation de 6 colonnes lombaires humaines fraiches (L2-sacrum). Chaque colonne etait testee en flexion et en extension de 0 a 10 N/m apres preparation et marquage des trois foramens d’interets. Une acquisition stereoscopique 3D etait realisee a vide puis apres implantation de chaque dispositif en L4-L5. La surface foraminale etait calculee en L4-L5 ainsi qu’aux etages adjacents. Resultats En L4-L5, deux categories d’implants se distinguent : les implants possedant une fixation epineuse (Wallis® et Diam®) ouvrent le foramen en extension. Les implants qui ne possedent pas de fixation epineuse (Xstop® et In-Space®) ouvrent le foramen au repos, en flexion et en extension. La mise en place des implants en L4-L5 n’avait aucune consequence sur la taille du foramen a l’etage L3-L4. Xstop® et Diam® entrainaient une fermeture du foramen L5-S1 vers l’extension. Conclusion Ce travail montre que les implants inter epineux ont bien un effet sur la surface des foramens inter epineux in vitro. Des etudes cliniques sont necessaires pour preciser leurs indications. Niveau de preuve Niveau IV. Examen d’un dispositif orthopedique.

Background Lumbar spinal stenosis is a major public health issue. Interspinous devices implanted using minimally invasive techniques may constitute an alternative to the reference standard of bony decompression with or without intervertebral fusion. However, their indications remain unclear, due to a paucity of clinical and biomechanical data. Our objective was to evaluate the effects of four interspinous process devices implanted at L4–L5 on the intervertebral foramen surface areas at the treated and adjacent levels, in flexion and in extension. Materials and method Six fresh frozen human cadaver lumbar spines (L2–sacrum) were tested on a dedicated spinal loading frame, in flexion and extension, from 0 to 10 N·m, after preparation and marking of the L3–L4, L4–L5, and L5–S1 foramina. Stereoscopic 3D images were acquired at baseline then after implantation at L4–L5 of each of the four devices (Inspace ® , Synthes; X-Stop ® , Medtronic; Wallis ® , Zimmer; and Diam ® , Medtronic). The surface areas of the three foramina of interest were computed. Results All four devices significantly opened the L4–L5 foramen in extension. The effects in flexion separated the devices into two categories. With the two devices characterized by fixation in the spinous processes (Wallis ® and Diam ® ), the L4–L5 foramen opened only in extension; whereas with the other two devices (X-Stop ® and Inspace ® ), the L4–L5 foramen opened not only in extension, but also in flexion and in the neutral position. None of the devices implanted at L4–L5 modified the size of the L3–L4 foramen. X-Stop ® and Diam ® closed the L5–S1 foramen in extension, whereas the other two devices had no effect at this level. Conclusion Our results demonstrate that interspinous process devices modify the surface area of the interspinous foramina in vitro. Clinical studies are needed to clarify patient selection criteria for interspinous process device implantation. Level of evidence Level IV. Investigating an orthopaedic device.

Resume Introduction Les liens sous-lamaires sont utilises dans des montages hybrides pour la correction des scolioses idiopathiques de l’adolescent depuis 2003. Aucune complication secondaire au passage des liens en sous-lamaire n’a ete rapportee a ce jour. Pourtant, certains chirurgiens restent reticents a leur utilisation en raison des complications secondaires a la technique de Luque. L’utilisation des liens en sous-transversaire pourrait donc constituer une alternative. Cette etude compare l’utilisation des liens sous-lamaires et sous-transversaires dans la correction des scolioses idiopathiques de l’adolescent. Materiel et methode Deux cohortes de patients presentant une scoliose idiopathique de l’adolescent ont ete revues de maniere retrospective avec un recul moyen de deux ans. Dans tous les cas, la correction a ete realisee par un montage hybride et une translation posteromediale. Dans le groupe 1 (20 patients), les liens ont ete utilises en sous-lamaires. Dans le groupe 2 (20 patients), les liens ont ete passes sous les apophyses transverses. L’angle de Cobb a ete mesure pour chaque courbure, de meme que la cyphose thoracique et la rotation de la vertebre apicale. Resultats La duree moyenne d’intervention etait similaire dans les deux groupes (235 ± 35 et 240 ± 30 minutes). La correction obtenue pour la courbure principale etait similaire dans les deux groupes, 62,5 % ± 17,4 % pour le groupe 1 et 54,1 ± 19,4 % pour le groupe 2. La correction obtenue dans le plan sagittal etait egalement similaire dans les deux groupes avec une cyphose thoracique moyenne mesuree a 30,9° ± 9,7° dans le groupe 1 et 27,8° ± 6,8° dans le groupe 2. Il n’y avait pas de difference significative pour la correction de la rotation de la vertebre apicale entre les deux groupes, 65,8 % ± 29,1 dans le groupe 1 et 54,4 % ± 42,7 % pour le groupe 2. Aucune fracture d’apophyse transverse ou de lame n’a ete constatee. Conclusion L’utilisation des liens sous les apophyses transverses est une technique fiable et efficace pour la correction du plan frontal et du plan sagittal dans les scolioses idiopathiques de l’adolescent et constitue une alternative a leur utilisation en sous-lamaire. Niveau de preuve IV.

The assessment of spinal flexibility is essential for the planning of adolescent idiopathic scoliosis (AIS) surgery. Various radiographic methods have been used but none of them has shown any superiority. The new low-dose stereography system EOS (EOS imaging, Paris, France) captures whole body images in a single scan without vertical distortion. EOS is now used in routine clinical use for AIS follow-up. The aim of this study was to prospectively evaluate the feasibility and the reproducibility of a new suspension test during the EOS imaging for the assessment of spinal flexibility in AIS. Fifty AIS patients scheduled for surgery were prospectively included. For each patient, a standard EOS radiograph was obtained, then a suspension test in the EOS and a classic traction test on the cotrel frame were performed. The examinations were compared in terms of radiation exposure, tolerance, mean traction force, and Cobb angle reduction for each curve. Axial and sagittal reductions during suspension were analyzed on three-dimensional EOS reconstructions. The tolerance of the suspension test was lower than the traction test but it was less operator dependent. Radiation exposure was 7 times lower during the suspension test. Cobb angle reductions achieved in the proximal and main curves by the two tests were similar. The traction test achieved greater reduction of the distal curve. Flexibility in the axial plane and in the sagittal plane was analyzed with the suspension test. The reduction in apical rotation was not correlated with the reduction in Cobb angle. The EOS suspension test can be used for the assessment of spinal flexibility in AIS. It gives a global vision of the deformity with new flexibility indices in the axial and sagittal planes.

Measuring foraminal stenosis is generally determined by an area calculation. It is difficult to know exactly where it is most appropriate to measure. No precise data are available on a method for calculating the foraminal volume using a CT. To develop a new method for measuring lumbar foraminal volume, we analyzed repeatability and reliability for measuring methods for foraminal volume using CT.The measurements were performed using a CT scan from ten healthy patients, with a mean age of 26.3 years. L3-L4, L4-L5 and L5-S1 foramen were studied, to obtain 60 foraminal measurements. Inter- and intra-observer reproducibility was calculated. Each series was analyzed using the VitreaCore® reconstruction software for volume calculation.Average volume measurements of 60 foramina and 20 L4-L5 foramina were, respectively, 1.17 and 1.25 mm(3) for observer 1 and 1.21 and 1.29 for observer 2. The intra-observer correlation coefficients for observer 1 when measuring all foramina and L4-L5 foramina were 0.98 and 0.99, respectively. For observer 2, coefficients were 0.90 and 0.92, respectively. The inter-observer correlation coefficients for observer 1 when measuring all foramina and L4-L5 foramina were 0.78 and 0.83, respectively. For observer 2, coefficients were 0.77 and 0.8, respectively. The average differences in intra- and inter-observer measurements regardless of the evaluator group were less than 0.2 mm(3).This is the first study measuring lumbar foraminal volume using CT. The excellent reproducibility of this simple measure can supplement a range of foramen measurement tools.

STUDY DESIGN: This is a biomechanical study. OBJECTIVE: Measuring changes in foraminal size after L4-L5 interspinous devices implantation. SUMMARY OF BACKGROUND DATA: Low-back pain aetiologies include foraminal stenoses. A niche is developing for interspinal implants that are minimally invasive with few harmful side effects. At present, we do not have sufficient understanding about their impact on the foraminal opening. METHODS: Six fresh L2-S1 columns were prepared with preservation of the capsuloligamentary and discal structures. The L4-L5 foramen was particularly carefully prepared. A 2-dimensional photographic analysis measured the length and width of the foramen and the extraforaminal surface, both before and after the implantation of a supple interspinal device that preserves the supraspinal ligaments. Photographic calibration and the use of precise and identical photographic landmarks (pixels) permitted the calculation of the foraminal deformity. A Wilcoxon test was performed for statistical analysis with P

BACKGROUND The Universal Clamp (UC) is a novel vertebral anchor consisting of a sublaminar polyester band connected to fusion rods by a titanium jaw locked with a screw. The authors prospectively studied patients treated for thoracic or lumbar burst fractures with short pedicle screw constructs reinforced with UCs to prevent screw pullout. METHODS Eleven patients below 18 years of age underwent 2-stage circumferential fusion for complete burst fractures (Magerl A 3.3). Two pedicle screws reinforced by 2 UCs were inserted in the vertebra proximal to the fracture and 2 pedicle screws reinforced by 2 UCs were inserted in the vertebra distal to the fracture. Within 7 days, cages filled with cancellous bone graft were added for anterior column support. T12 was fractured in 3 patients, L1 in 4, L3 in 2, and L4 in 2 patients. Preoperatively, 10 patients were neurologically intact (Frankel E) and 1 patient had an incomplete spinal cord injury (Frankel C). RESULTS Mean operative duration for the posterior and anterior procedures was 110±24 and 120±35 minutes, respectively. Average intraoperative blood loss was 355±60 mL. Mean hospital stay was 11±2 days and follow-up averaged 36.1±5 months. Mean kyphotic deformity was corrected from 25±9 to 5.3±4.5 degrees postoperatively (79%), without subsequent loss of correction (P=0.17). Regional kyphosis improved by 20±8 degrees postoperatively, without subsequent loss of correction (P=0.09). No intraoperative complication was observed. There was no neurological deterioration. The patient who had a Frankel C lesion recovered 1 Frankel level (Frankel D) at final follow-up. None of the patients exhibited significant correction loss during follow-up, and there was no pseudarthrosis. CONCLUSIONS Thoracic and lumbar complete burst fractures in skeletally immature patients can be treated using anterior bone graft cages and posterior instrumented fusion augmented with UCs to prevent pedicle screw pullout. With these constructs, which are short to preserve mobile intervertebral segments, kyphosis was corrected, fusion achieved, and correction maintained in all subjects without neurological worsening. LEVEL OF EVIDENCE Level IV.

Purpose Sublaminar polyester bands have been used in hybrid construct to achieve correction of adolescent idiopathic scoliosis since 2003. Despite the reported safety of the bands, some surgeons remain reluctant at the idea of approaching the canal because of the potential neurological complications reported with the Luque wiring. Sub transverse bands might be an alternative. The present study is the first to compare sublaminar polyester band fixation to fixation of polyester bands around the transverse processes in hybrid constructs used to treat AIS. Methods Two cohorts of consecutive patients treated for thoracic AIS were retrospectively reviewed, with a minimum 2-year follow-up. Posteromedial translation was used for main curve correction in all cases. Sublaminar polyester bands were used in group 1 (20 patients). In group 2 (20 patients), the same implant was used, but the bands were passed around the transverse process instead of the lamina. Radiographic analysis included frontal Cobb angle measurements for each curve, thoracic kyphosis and rotation of the apical vertebra (RVA). Results Mean operative time was similar in groups 1 and 2 (235 ± 35 and 240 ± 30 minutes, respectively). Mean frontal correction achieved for the main curve was similar in both groups, 62.5 ± 17.4% in group 1 and 54.1 ± 19.4% in group 2. Sagittal correction was similar, with a final mean thoracic kyphosis of 30.9° ± 9.7° and 27.8°± 6.8° in group 1 and 2, respectively. Correction of RVA was similar in both groups postoperatively, 65.8% (± 29.1) and 54.4% (± 42.7) in group 1 and 2 respectively. No transverse process or lamina fracture was observed during insertion of the bands or curve correction in any of the groups. Conclusion This study confirms that anchorage of Universal clamps (UCs) around transverse processes is a safe and efficacious technique in both the frontal and sagittal planes, providing a useful alternative for the correction of moderate AIS. UCs attached to transverse processes can achieve correction of moderate AIS similar to that obtained with sublaminar UCs while further reducing risks of vertebral canal complications. Level of evidence Level IV.