Indications à la laminectomie : adéquation et nécessité

[Table des matières] I. Objectifs du projet. II. Méthode. III. Résultats et réalisations. IV. Evaluation. V. Utilisations possibles et mise en garde. VI. Conclusions et recommendations. VII. Membres du panel d'experts. VIII. Revue de la littérature médicale sur efficacité de l'opération pour hernie discale. IX. Définitions utilisées pour les scénarios cliniques. X. Notes sur la lecture des tableaux d'adéquation "appropriateness". XI. Tableaux des scénarios d'adéquation, évalués par les experts. XII. Tableaux des scénarios de nécessité, évalués par les experts. XIII. Résumé du projet d'étude soumis au Fonds national (Dr F. Porchet). XIV. Résumé du projet d'étude soumis au Fonds national (Dr J.P. Vader). XV. Evaluation du processus par les experts. XVI. Extraits de pages du site WWW "Aide à la décision médicale"

Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain

Purpose: To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines. Methods: Seventy outpatients with chronic low back pain were recruited from six spine centres in Switzerland and France. They completed the newly translated COMI, and the Roland Morris disability (RMQ), Dallas Pain (DPQ), adjectival pain rating scale, WHO Quality of Life, and EuroQoL-5D questionnaires. After ~14days RMQ and COMI were completed again to assess reproducibility; a transition question (7-point Likert scale; "very much worse” through "no change” to "very much better”) indicated any change in status since the first questionnaire. Results: COMI whole scores displayed no floor effects and just 1.5% ceiling effects. The scores for the individual COMI items correlated with their corresponding full-length reference questionnaire with varying strengths of correlation (0.33-0.84, P<0.05). COMI whole scores showed a very good correlation with the "multidimensional” DPQ global score (Rho=0.71). 55 patients (79%) returned a second questionnaire with no/minimal change in their back status. The reproducibility of individual COMI 5-point items was good, with test-retest differences within one grade ranging from 89% for ‘social/work disability' to 98% for ‘symptom-specific well-being'. The intraclass correlation coefficient for the COMI whole score was 0.85 (95% CI 0.76-0.91). Conclusions: In conclusion, the French version of this short, multidimensional questionnaire showed good psychometric properties, comparable to those reported for German and Spanish versions. The French COMI represents a valuable tool for future multicentre clinical studies and surgical registries (e.g. SSE Spine Tango) in French-speaking countrie

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

Monoclonal antibodies (mAbs) play an increasing important role in the therapeutic armamentarium against multiple sclerosis (MS), an inflammatory and degenerative disorder of the central nervous system. Most of the mAbs currently developed for MS are immunomodulators blocking the inflammatory immune process. In contrast with mAbs targeting immune function, GNbAC1, a humanized IgG4 mAb, targets the multiple sclerosis associated retrovirus envelope (MSRVEnv) protein, an upstream factor in the pathophysiology of MS. MSRV-Env protein is of endogenous retroviral origin, expressed in MS brain lesions, and it is pro-inflammatory and toxic to the remyelination process, by preventing the differentiation of oligodendrocyte precursor cells. We present the preclinical and early clinical development results of GNbAC1. The specificity of GNbAC1 for its endogenous retroviral target is described. Efficacy of different mAb versions of GNbAC1 were assessed in MSRV-Env induced experimental allergic encephalitis (EAE), an animal model of MS. Because the target MSRV-Env is not expressed in animals, no relevant animal model exists for a proper in vivo toxicological program. An off-target 2-week toxicity study in mice was thus performed, and it showed an absence of safety risk. Additional in vitro analyses showed an absence of complement or antibody-dependent cytotoxicity as well as a low level of cross-reactivity to human tissues. The first-in-man clinical study in 33 healthy subjects and a long-term clinical study in 10 MS patients showed that GNbAC1 is well tolerated in humans without induction of immunogenicity and that it induces a pharmacodynamic response on MSRV biomarkers. These initial results suggest that the mAb GNbAC1 could be a safe long-term treatment for patients with MS with a unique therapeutic mechanism of action.GeNeuro SA, Geneva, Switzerlandhttp://www.tandfonline.com/loi/kmab202016-01-31hb201

LumbSten: The lumbar spinal stenosis outcome study

BACKGROUND: Lumbar spinal stenosis is the most frequent reason for spinal surgery in elderly people. For patients with moderate or severe symptoms different conservative and surgical treatment modalities are recommended, but knowledge about the effectiveness, in particular of the conservative treatments, is scarce. There is some evidence that surgery improves outcome in about two thirds of the patients. The aims of this study are to derive and validate a prognostic prediction aid to estimate the probability of clinically relevant improvement after surgery and to gain more knowledge about the future course of patients treated by conservative treatment modalities. METHODS/DESIGN: This is a prospective, multi-centre cohort study within four hospitals of Zurich, Switzerland. We will enroll patients with neurogenic claudication and lumbar spinal stenosis verified by Computer Tomography or Magnetic Resonance Imaging. Participating in the study will have no influence on treatment modality. Clinical data, including relevant prognostic data, will be collected at baseline and the Swiss Spinal Stenosis Questionnaire will be used to quantify severity of symptoms, physical function characteristics, and patient's satisfaction after treatment (primary outcome). Data on outcome will be collected 6 weeks, and 6, 12, 24 and 36 months after inclusion in the study. Applying multivariable statistical methods, a prediction rule to estimate the course after surgery will be derived. DISCUSSION: The ultimate goal of the study is to facilitate optimal, knowledge based and individualized treatment recommendations for patients with symptomatic lumbar spinal stenosis

Incidence of Revision Surgery After Decompression With vs Without Fusion Among Patients With Degenerative Lumbar Spinal Stenosis.

Importance Only limited data derived from large prospective cohort studies exist on the incidence of revision surgery among patients who undergo operations for degenerative lumbar spinal stenosis (DLSS). Objective To assess the cumulative incidence of revision surgery after 2 types of index operations-decompression alone or decompression with fusion-among patients with DLSS. Design, Setting, and Participants This cohort study analyzed data from a multicenter, prospective cohort study, the Lumbar Stenosis Outcome Study, which included patients aged 50 years or older with DLSS at 8 spine surgery and rheumatology units in Switzerland between December 2010 and December 2015. The follow-up period was 3 years. Data for this study were analyzed between October and November 2021. Exposures All patients underwent either decompression surgery alone or decompression with fusion surgery for DLSS. Main Outcomes and Measures The primary outcome was the cumulative incidence of revision operations. Secondary outcomes included changes in the following patient-reported outcome measures: Spinal Stenosis Measure (SSM) symptom severity (higher scores indicate more pain) and physical function (higher scores indicate more disability) subscale scores and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire (EQ-5D-3L) summary index score (lower scores indicate worse quality of life). Results A total of 328 patients (165 [50.3%] men; median age, 73.0 years [IQR, 66.0-78.0 years]) were included in the analysis. Of these, 256 (78.0%) underwent decompression alone and 72 (22.0%) underwent decompression with fusion. The cumulative incidence of revisions after 3 years of follow-up was 11.3% (95% CI, 7.4%-15.1%) for the decompression alone group and 13.9% (95% CI, 5.5%-21.5%) for the fusion group (log-rank P = .60). There was no significant difference in the need for revision between the 2 groups over time (unadjusted absolute risk difference, 2.6% [95% CI, -6.3% to 11.4%]; adjusted absolute risk difference, 3.9% [95% CI, -5.2% to 17.0%]; adjusted hazard ratio, 1.40 [95% CI, 0.63-3.13]). The number of revisions was significantly associated with higher SSM symptom severity scores (β, 0.171; 95% CI, 0.047-0.295; P = .007) and lower EQ-5D-3L summary index scores (β, -0.061; 95% CI, -0.105 to -0.017; P = .007) but not with higher SSM physical function scores (β, 0.068; 95% CI, -0.036 to 0.172; P = .20). The type of index operation was not significantly associated with the corresponding outcomes. Conclusions and Relevance This cohort study showed no significant association between the type of index operation for DLSS-decompression alone or fusion-and the need for revision surgery or the outcomes of pain, disability, and quality of life among patients after 3 years. Number of revision operations was associated with more pain and worse quality of life

Five-year results of cervical disc prostheses in the SWISSspine registry

Background: The Swiss Federal Office of Public Health demanded a nationwide HTA-registry for cervical total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of cervical TDA. Materials and methods: Three hundred thirty-two cases treated between 3.2005 and 6.2006 who were eligible for 5years follow-ups were included in the study. Follow-up rates for 3-6months, 1, 2 and 5years were 84.6, 74.4, 50.6 and 64.8%, respectively. Outcome measures were neck and arm pain, medication, quality of life, intraoperative and postoperative complication and revision rates. In addition, segmental mobility, ossification, adjacent and distant segment degeneration were analyzed at the 5-year follow-up. Results: There was significant, clinically relevant and lasting reduction of neck (preop/postop 60/21 VAS points) and arm pain (preop/postop VAS 67/17) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.39/0.82 EQ-5D points) until the 5-year follow-up. The rates for intraoperative and early postoperative complications were 0.6 and 7.2%, respectively. In 0.6% an early and in 3.9% a late revision surgery was performed. At the 5-year follow-up, the average range of motion of the mobile segments (88.2%) was 10.2°. In 40.7% of the patients osteophytes at least potentially affecting range of motion were seen. Conclusions: Cervical TDA appeared as safe and efficient in long-term pain alleviation, consequent reduction of pain killer consumption and in improvement of quality of life. The improvement is stable over the 5years postoperative period. The vast majority of treated segments remained mobile after 5years, although 40.7% of patients showed osteophyte

Five-year results of lumbar disc prostheses in the SWISSspine registry

Purpose: The Swiss Federal Office of Public Health demanded a nationwide HTA registry for lumbar total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISS spine registry is to generate evidence about the safety and efficiency of lumbar TDA. Methods: Two hundred forty-eight cases treated between 3-2005 and 6-2006, who were eligible for the 5-year follow-up were included in the study. Follow-up rates for 3-6months, 1, 2 and 5years were 85.9, 77.0, 44.0 and 51.2%, respectively. Outcome measures were back and leg pain, medication consumption, quality of life, intraoperative and postoperative complication and revision rates. Additionally, segmental mobility, ossification, adjacent and distant segment degeneration were analysed at the 5-year follow-up. Results: There was a significant, clinically relevant and lasting reduction of back (preop/postop 73/29 VAS points) and leg pain (preop/postop VAS 55/22) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.30/0.76 EQ-5D score points) until 5years after surgery. The rates for intraoperative and early postoperative complications were 4.4 and 3.2%, respectively. The overall complication rate during five postoperative years was 23.4%, and the adjacent segment degeneration rate was 10.7%. In 4.4 % of patients, a revision surgery was performed. Cumulative survivorship probability for a revision/re-intervention-free 5-year postoperative course was 90.4%. At the 5-year follow-up, the average range of motion of the mobile segments (86.8%) was 9.7°. In 43.9% of patients, osteophytes at least potentially affecting the range of motion were seen. Conclusions: Lumbar TDA appeared as efficient in long-term pain alleviation, consequent reduction of pain medication consumption and improvement of quality of life. The procedure also appeared sufficiently safe, but surgeons have to be aware of a list of potential adverse events. The outcome is stable over the 5-year postoperative period. The vast majority of treated segments remained mobile after 5years, although almost half of patients showed osteophytes

Creatine and guanidinoacetate reference values in a French population

Creatine and guanidinoacetate are biomarkers of creatine metabolism. Their assays in body fluids may be used for detecting patients with primary creatine deficiency disorders (PCDD), a class of inherited diseases. Their laboratory values in blood and urine may vary with age, requiring that reference normal values are given within the age range. Despite the long known role of creatine for muscle physiology, muscle signs are not necessarily the major complaint expressed by PCDD patients. These disorders drastically affect brain function inducing, in patients, intellectual disability, autistic behavior and other neurological signs (delays in speech and language, epilepsy, ataxia, dystonia and choreoathetosis), being a common feature the drop in brain creatine content. For this reason, screening of PCDD patients has been repeatedly carried out in populations with neurological signs. This report is aimed at providing reference laboratory values and related age ranges found for a large scale population of patients with neurological signs (more than 6 thousand patients) previously serving as a background population for screening French patients with PCDD. These reference laboratory values and age ranges compare rather favorably with literature values for healthy populations. Some differences are also observed, and female participants are discriminated from male participants as regards to urine but not blood values including creatine on creatinine ratio and guanidinoacetate on creatinine ratio values. Such gender differences were previously observed in healthy populations; they might be explained by literature differential effects of testosterone and estrogen in adolescents and adults, and by estrogen effects in prepubertal age on SLC6A8 function. Finally, though they were acquired on a population with neurological signs, the present data might reasonably serve as reference laboratory values in any future medical study exploring abnormalities of creatine metabolism and transport

Prognosis or "curabo effect?": physician prediction and patient outcome of surgery for low back pain and sciatica

STUDY DESIGN: Prospective study with patient and physician questionnaires, clinical records, and imaging. OBJECTIVE: To compare physician expectations of surgery for sciatica and patient outcome. SUMMARY OF BACKGROUND DATA: Physician accuracy in identifying individual patient prognosis is important for therapeutic decisions. METHODS: A total of 197 consecutive patients with low back pain and/or sciatica who underwent low back surgery in the University Hospital of Lausanne, Switzerland. RESULTS: Physicians predicted "a great improvement" of quality of life after surgery for 79% and "moderate improvement" for 20% (1% others); 39% of patients had no "minimal clinically important difference" in back pain after surgery, despite physician prediction of "great improvement." Correlations between physician expectation and various dimensions of patient outcome were not significant, and agreement with patient global judgment of 1-year outcome was poor (kappa = 0.03). However, in a subgroup where the indication for treatment was not considered appropriate, physician prediction of "great improvement" was followed by greater improvement outcome on SF-36 mental component score (P = 0.05), mental health (0.02), and general health (0.03) compared with patients where the physician did not predict "great improvement." CONCLUSION: Despite clear average improvement, surgeons tended to give overly optimistic predictions that were not correlated with patient outcome. For patients receiving a treatment not meeting explicit criteria of appropriateness, more optimistic physician expectation was associated with better improvement of psychological dimensions. Besides prognostic ability, the influence of physician expectation on patient outcome is discussed and the concept of "curabo effect" (differentiated from "placebo effect") proposed