BACKGROUND: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica caused by lumbar disk herniation. Transmuscular tubular diskectomy has been introduced... Show moreBACKGROUND: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica caused by lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence of its efficacy is lacking. OBJECTIVE: To determine whether a favorable cost-effectiveness for tubular diskectomy compared with conventional microdiskectomy is attained. METHODS: Cost utility analysis was performed alongside a double-blind randomized controlled trial conducted among 325 patients with lumbar disk related sciatica lasting >6 to 8 weeks at 7 Dutch hospitals comparing tubular diskectomy with conventional microdiskectomy. Main outcome measures were quality-adjusted life-years at 1 year and societal costs, estimated from patient reported utilities (US and Netherlands EuroQol, Short Form Health Survey-6D, and Visual Analog Scale) and diaries on costs (health care, patient costs, and productivity). RESULTS: Quality-adjusted life-years during all 4 quarters and according to all utility measures were not statistically different between tubular diskectomy and conventional microdiskectomy (difference for US EuroQol, -0.012; 95% confidence interval, -0.046 to 0.021). From the healthcare perspective, tubular diskectomy resulted in nonsignificantly higher costs (difference US $460; 95% confidence interval, -243 to 1163). From the societal perspective, a nonsignificant difference of US $1491 (95% confidence interval, -1335 to 4318) in favor of conventional microdiskectomy was found. The nonsignificant differences in costs and quality-adjusted life-years in favor of conventional microdiskectomy result in a low probability that tubular diskectomy is more cost-effective than conventional microdiskectomy. CONCLUSION: Tubular diskectomy is unlikely to be cost-effective compared with conventional microdiskectomy. Show less
BACKGROUND: Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking. OBJECTIVE: To evaluate the 2-year results of tubular diskectomy... Show moreBACKGROUND: Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking. OBJECTIVE: To evaluate the 2-year results of tubular diskectomy compared with conventional microdiskectomy. METHODS: Three hundred twenty-eight patients with persistent leg pain caused by lumbar disk herniation were randomly assigned to undergo tubular diskectomy (167 patients) or conventional microdiskectomy (161 patients). Main outcome measures were scores from Roland-Morris Disability Questionnaire for Sciatica, Visual Analog Scale for leg pain and low-back pain, and Likert self-rating scale of global perceived recovery. RESULTS: On the basis of intention-to-treat analysis, there was no significant difference between tubular diskectomy and conventional microdiskectomy in Roland-Morris Disability Questionnaire for Sciatica scores during 2 years after surgery (between-group mean difference [Delta] = 0.6; 95% confidence interval [CI], 20.3-1.6). Patients treated with tubular diskectomy reported more leg pain (Delta = 3.3 mm; 95% CI, 0.2-6.2) and more low-back pain (Delta = 3.0 mm; 95% CI, 20.2-6.3) than those patients treated with conventional microdiskectomy. At 2 years, 71% of patients assigned to tubular diskectomy documented a good recovery vs 77% of patients assigned to conventional microdiskectomy (odds ratio, 0.76; 95% CI, 0.45-1.28; P = .35). Repeated surgery rates within 2 years after tubular diskectomy and conventional microdiskectomy were 15% and 10%, respectively (P = .22). CONCLUSION: Tubular diskectomy and conventional microdiskectomy resulted in similar functional and clinical outcomes. Patients treated with tubular diskectomy reported more leg pain and low-back pain, although the differences were small and not clinically relevant. Show less
Witte, P.B. de; Brand, R.; Vermeer, H.G.W.; Heide, H.J.L. van der; Barnaart, A.F.W. 2011
Background: Except for those reported by the designers, there are no published mid-term results of the use of the Cement Less Spotorno (CLS) Total Hip Arthroplasty system. We present the results of... Show moreBackground: Except for those reported by the designers, there are no published mid-term results of the use of the Cement Less Spotorno (CLS) Total Hip Arthroplasty system. We present the results of (1) a ten to seventeen-year follow-up prospective cohort study of this system, and (2) retrospective analyses of factors influencing clinical and radiographic outcomes. Methods: We studied a series of 102 consecutive CLS arthroplasties with a minimal duration of follow-up of ten years. Indications for the procedures were osteoarthritis (n = 90), rheumatoid arthritis (n = 8), and femoral head osteonecrosis (n = 4). The Merle d'Aubigne-Postel score, polyethylene wear, and radiographic status were recorded at regular intervals. Survival analyses, repeated-measures analysis of variance, and a nested case-control study (with the cases having early revision due to aseptic cup loosening within ten years after the index procedure and the controls having no early cup revision) were used for evaluation. Results: There were fourteen revisions, including nine due to aseptic cup loosening. The ten-year Kaplan-Meier survival rate was 92.2% (95% confidence interval [CI] = 86.9 to 97.5) with revision for any reason as the end point. The fifteen-year survival rate was 78.4% (95% CI = 63.9 to 92.9) with revision for any reason as the end point, 81.6% (95% CI = 6.7 to 96.5) with revision due to aseptic cup loosening as the end point, and 99.0% (95% CI = 97.0 to 100.0) with revision due to aseptic stem loosening as the end point. The average amount of polyethylene wear at the time of final follow-tip was 1.92 mm (range, 0.6 to 4.3 mm). The wear rate in the cases was significantly higher than that in the controls (0.31 vs. 0.16 mm/yr, p < 0.001). Factors with a significant effect on polyethylene wear were age at surgery (a 0.3-mm increase per every ten years younger, p = 0.001) and a larger head component (an effect of 0.53 mm for the 32 vs. the 28-mm component; p < 0.0001). Male sex had an effect of -0.66 point (p = 0.07) on the final Merle d'Aubigne-Postel score. Conclusions: The results of this CLS system, particularly with regard to the femoral stem, are comparable with those with other reliable cementless systems. Nevertheless, the prevalence of aseptic acetabular cup loosening in the second decade after the operation demonstrates a potentially substantial problem with regard to long-term survival. A high polyethylene wear rate, male sex, a younger age at the time of surgery, and a 32-mm head component size are related to inferior clinical outcomes and a higher risk of implant revision. Show less
Background: Ingestion of high doses of casein hydrolysate stimulates insulin secretion in healthy subjects and patients with type 2 diabetes. The effects of low doses have not been studied. The aim... Show moreBackground: Ingestion of high doses of casein hydrolysate stimulates insulin secretion in healthy subjects and patients with type 2 diabetes. The effects of low doses have not been studied. The aim of this study was to assess the effect of lower doses of a casein hydrolysate on the glucose and insulin responses to an oral glucose tolerance test in patients with type 2 diabetes. Methods: In this randomized, placebo-controlled, double-blind study, thirteen patients with type 2 diabetes (age: 58 +/- 1 years) were studied. Glucose, insulin and C-peptide responses were determined after the oral administration of 0 (control), 6 or 12 g protein hydrolysate in combination with 50 g carbohydrate. Results: Twelve grams of casein hydrolysate, but not 6 g, elevated insulin levels and decreased glucose levels post-challenge. These changes over time were not large enough to also affect the total area under the curve of glucose and insulin. C-peptide levels did not change after both treatments. Conclusion: Ingestion of six grams of casein hydrolysate did not affect glucose or insulin responses. Intake of 12 g of casein hydrolysate has a small positive effect on post-challenge insulin and glucose levels in patients with type 2 diabetes. (C) 2011 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved. Show less
Purpose A comprehensive quality management system called JACIE (Joint Accreditation Committee International Society for Cellular Therapy and the European Group for Blood and Marrow Transplantation)... Show morePurpose A comprehensive quality management system called JACIE (Joint Accreditation Committee International Society for Cellular Therapy and the European Group for Blood and Marrow Transplantation), was introduced to improve quality of care in hematopoietic stem-cell transplantation (HSCT). We therefore tested the hypothesis that the introduction of JACIE improved patient survival. Patients and Methods Data on 41,623 allogeneic (39%) and 66,281 autologous (61%) HSCTs for an acquired hematologic disorder performed between 1999 and 2007 by 421 teams in Europe were used to assess the outcomes of patients who received a transplantation at baseline (> 3 years before application or no application), during preparation (3 years before application), during application (time from application to accreditation), and after JACIE accreditation. The analysis was clustered by team and stratified for year of HSCT, donor type, disease, conditioning, and gross national income per capita of the respective country. Patient's risks were adjusted for by their European Group for Blood and Marrow Transplantation score. Results Patient outcome was systematically better when the transplantation center was at a more advanced phase of JACIE accreditation, independent of year of transplantation and other risk factors. Improvement was robust as quantified for relapse-free survival after allogeneic HSCT compared with baseline by a hazard ratio (HR) of 0.96 (95% CI, 0.90 to 1.03; P = .22) for preparation, 0.95 (95% CI, 0.88 to 1.03; P = .20) for application, and 0.86 (95% CI, 0.78 to 0.95; P = .01) for the accreditation (test for trend P = .01). Improvement from baseline was similar after autologous HSCT (HR for accreditation, 0.83; 95% CI, 0.74 to 0.93; P < .01). Conclusion Even with all the limitations of an observational study, these findings support the hypothesis that introduction of a comprehensive clinical quality management system is associated with improved outcome of patients after HSCT. J Clin Oncol 29:1980-1986. (C) 2011 by American Society of Clinical Oncology Show less
Background: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However... Show moreBackground: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis. Methods/Design: The aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting to the neurologist or neurosurgeon with at least 3 months complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion. Participants are randomly allocated to either prolonged conservative treatment, receiving further treatment from their general practitioner and physical therapist, or allocated to surgery and operated within 4 weeks. Primary outcome measure is the functional assessment of the patient as measured by the Zurich Claudication Questionnaire at 24 months of follow-up. Data is analyzed according to the intention to treat principle. Discussion: With a cost-effectiveness analysis the trade off between the costs of prolonged conservative treatment and delayed surgery in a smaller number of patients are compared with the current policy of surgical management. As surgery is expected to be inevitable in certain subgroups of patients, the distinction of and classification by predictive patient characteristics is most relevant to clinical practice. Show less
BACKGROUND:: Transmuscular tubular discectomy has been introduced to increase the rate of recovery, although evidence is lacking. OBJECTIVE:: To evaluate the 2-year results of tubular discectomy... Show moreBACKGROUND:: Transmuscular tubular discectomy has been introduced to increase the rate of recovery, although evidence is lacking. OBJECTIVE:: To evaluate the 2-year results of tubular discectomy compared with conventional microdiscectomy. METHODS:: 328 patients with persistent leg pain due to lumbar disc herniation were randomly assigned to undergo tubular discectomy (167 patients) or conventional microdiscectomy (161 patients). Main outcome measures were scores from Roland-Morris Disability Questionnaire for Sciatica (RDQ), visual analogue scale (VAS) for leg pain and low-back pain, and Likert self-rating scale of global perceived recovery. RESULTS:: Based on intention-to-treat analysis, there was no significant difference between tubular discectomy and conventional microdiscectomy in RDQ scores during 2 years after surgery (between-group mean difference (Δ) = 0.6; 95% CI, -0.3 to 1.6). Patients treated with tubular discectomy reported more leg pain (Δ = 3.3 mm; 95% CI, 0.2 to 6.2 mm) and more low-back pain (Δ = 3.0 mm; 95% CI, -0.2 to 6.3 mm) than those patients treated with conventional microdiscectomy. At 2 years, 71% of patients assigned to tubular discectomy documented a good recovery versus 77% of patients assigned to conventional microdiscectomy (odds ratio 0.76; 95% CI, 0.45 to 1.28; P=0.35). Repeated surgery rate within 2 years after tubular discectomy and conventional microdiscectomy was 15% and 10%, respectively (P=0.22). CONCLUSION:: Tubular discectomy and conventional microdiscectomy resulted in similar functional and clinical outcome. Patients treated with tubular discectomy reported more leg pain and low-back pain, although the differences were small and not clinically relevant. Show less
Arts, M.; Brand, R.; Kallen, B. van der; Nijeholt, G.L.A.; Peul, W. 2011
The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA)... Show moreThe concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury. We present the results of a double-blind randomized trial on patients with lumbar disc herniation, in which tubular discectomy and conventional microdiscectomy were compared. In 216 patients, CPK was measured before surgery and at day 1 after surgery. In 140 patients, the CSA of the multifidus muscle was measured at the affected disc level before surgery and at 1 year after surgery. The ratios (i.e. post surgery/pre surgery) of CPK and CSA were used as outcome measures. The multifidus atrophy was classified into three grades ranging from 0 (normal) to 3 (severe atrophy), and the difference between post and pre surgery was used as an outcome. Patients' low-back pain scores on the visual analogue scale (VAS) were documented before surgery and at various moments during follow-up. Tubular discectomy compared with conventional microdiscectomy resulted in a nonsignificant difference in CPK ratio, although the CSA ratio was significantly lower in tubular discectomy. At 1 year, there was no difference in atrophy grade between both groups nor in the percentage of patients showing an increased atrophy grade (14% tubular vs. 18% conventional). The postoperative low-back pain scores on the VAS improved in both groups, although the 1-year between-group mean difference of improvement was 3.5 mm (95% CI; 1.4-5.7 mm) in favour of conventional microdiscectomy. In conclusion, tubular discectomy compared with conventional microdiscectomy did not result in reduced muscle injury. Postoperative evaluation of CPK and the multifidus muscle showed similar results in both groups, although patients who underwent tubular discectomy reported more low-back pain during the first year after surgery. Show less
BACKGROUND Lower limb joint replacement surgery provides a considerable improvement in quality of life (QoL), but is associated with peroperative blood loss and with anemia in the direct... Show moreBACKGROUND Lower limb joint replacement surgery provides a considerable improvement in quality of life (QoL), but is associated with peroperative blood loss and with anemia in the direct postoperative period. General acceptance of low transfusion thresholds and shorter postoperative hospital stays will result in patients leaving hospital with low hemoglobin (Hb) levels. To evaluate the role of QoL scores as a possible alternative for Hb values to serve as a further indicator for red blood cell transfusion, we performed a secondary analysis of a previously conducted randomized clinical trial to compare QoL and fatigue scores with simultaneously measured pre- and postoperative Hb levels, in total hip and knee arthroplasty patients. STUDY DESIGN AND METHODS QoL measurement was measured preoperatively and twice up to 14 days postoperatively using the Functional Status Index (FSI), the Visual Analogue Score (VAS)-Fatigue score, and the Functional Assessment of Cancer Therapy Anemia (FACT-Anemia) subscale. Pearson correlation coefficients between (change in) FSI, VAS-Fatigue, and FACT-Anemia subscale scores and (change in) Hb levels were calculated. Additionally, partial correlations were calculated and linear regression analysis was performed, correcting for possible confounding variables. RESULTS A total of 603 patients were evaluated. All patients scored worse postoperatively, but none of the scores correlated with Hb values, neither after correcting for confounding factors. Even more, the changes between preoperative and postoperative Hb levels were not correlated with changes in fatigue scores. CONCLUSION In hip and knee prosthesis surgery no correlation existed between postoperative Hb levels or acute postoperative decline in Hb values and QoL scores (FSI, VAS-Fatigue, or FACT-Anemia). Show less
Objective In elective orthopaedic hip- and knee replacement surgery patients, we studied the effect of implementation of a uniform transfusion policy on RBC usage. Study Design and Methods A... Show moreObjective In elective orthopaedic hip- and knee replacement surgery patients, we studied the effect of implementation of a uniform transfusion policy on RBC usage. Study Design and Methods A randomized, controlled study. A new uniform, restrictive transfusion policy was compared with standard care, which varied among the three participating hospitals. Only prestorage leucocyte-depleted RBC(s) were used. Primary end-point was RBC usage, related to length of hospital stay. Secondary end-points were Hb levels, mobilization delay and postoperative complications. Results Six hundred and three patients were evaluated. Adherence to the protocol was over 95%. Overall mean RBC usage was 0 center dot 78 U/patient in the new policy group and 0 center dot 86 U/patient in the standard care policy group (mean difference 0 center dot 08;95% CI [-0 center dot 3; 0 center dot 2]; P = 0 center dot 53). In two hospitals, the new transfusion policy resulted in a RBC reduction of 30% (0 center dot 58U RBC/patient) (P = 0 center dot 17) and 41% (0 center dot 29 U RBC/patient) (P = 0 center dot 05) respectively. In the third hospital, however, RBC usage increased by 39% (0 center dot 31 U RBC/patient) (P = 0 center dot 02) with the new policy, due to a more restrictive standard care policy in that hospital. Length of hospital stay was not influenced by either policy. Conclusions Implementation of a uniform transfusion protocol for elective lower joint arthroplasty patients is feasible, but does not always lead to a RBC reduction. Length of hospital stay was not affected. Show less
Background Tubular discectomy compared with conventional microdiscectomy has been introduced to speed up the rate of recovery in patients with lumbar disc related sciatica, although similar results... Show moreBackground Tubular discectomy compared with conventional microdiscectomy has been introduced to speed up the rate of recovery in patients with lumbar disc related sciatica, although similar results have been shown. The authors performed a subgroup analysis to investigate whether certain patients might benefit more from either two surgical treatments. Methods A double-blinded randomised trial was performed to compare the rate of recovery and outcome at 1 year between tubular discectomy and conventional microdiscectomy. Complete and nearly complete recovery, documented on the patient's global perceived recovery, were defined as a good outcome. The effect modification of the allocated treatment strategy by predefined variables on the rate of recovery and outcome at 1 year was analysed by Cox proportional hazard analyses and logistic regression analyses, respectively. Results With respect to the outcome rate of recovery, interaction with treatment effect was present for the variable gender and type of disc herniation. Patients with a contained disc herniation (HR 0.73; 95% CI 0.49 to 1.09) and women (HR 0.75; 95% CI 0.54 to 1.06) had slower rates of recovery when treated with tubular discectomy. Variables correlated with good outcome at 1 year were the level of education and Slump test. Higher educated patients (OR 0.18; 95% CI 0.06 to 0.59) and patients with a negative Slump (OR 0.24; 95% CI 0.06 to 0.92) fared worse at 1 year when they underwent tubular discectomy. Conclusions Superiority of tubular discectomy compared with conventional microdiscectomy was not demonstrated. Subgroup analyses identified only a few variables that were associated with more or less benefit from one of the allocated treatments. Show less
Michallet, M.; Sobh, M.; Milligan, D.; Morisset, S.; Niederwieser, D.; Koza, V.; ... ; Chronic Leukemia Working Party EBM 2010
We analyzed 368 chronic lymphocytic leukemia patients who underwent allogeneic hematopoietic stem cell transplantation reported to the EBMT registry between 1995 and 2007. There were 198 human... Show moreWe analyzed 368 chronic lymphocytic leukemia patients who underwent allogeneic hematopoietic stem cell transplantation reported to the EBMT registry between 1995 and 2007. There were 198 human leukocyte antigen (HLA)-identical siblings; among unrelated transplants, 31 were well matched in high resolution ('well matched' unrelated donor, WMUD), and 139 were mismatched (MM), including 30 matched in low resolution; 266 patients (72%) received reduced-intensity conditioning and 102 (28%) received standard. According to the EBMT risk score, 11% were in scores 1-3, 23% in score 4, 40% in score 5, 22% in score 6 and 4% in score 7. There was no difference in overall survival (OS) at 5 years between HLA-identical siblings (55% (48-64)) and WMUD (59% (41-84)), P = 0.82. In contrast, OS was significantly worse for MM (37% (29-48) P = 0.005) due to a significant excess of transplant-related mortality. Also OS worsened significantly when EBMT risk score increased. HLA matching had no significant impact on relapse (siblings: 24% (21-27); WMUD: 35% (26-44), P = 0.11 and MM: 21% (18-24), P = 0.81); alemtuzumab T-cell depletion and stem cell source (peripheral blood) were associated with an increased risk. Our findings support the use of WMUD as equivalent alternative to HLA-matched sibling donors for allogeneic HSCT in CLL, and justify the application of EBMT risk score in this disease. Leukemia (2010) 24, 1725-1731; doi:10.1038/leu.2010.165; published online 12 August 2010 Show less
Background Non-HLA gene polymorphisms have been shown to influence outcome after allogeneic hematopoietic stem cell transplantation. Results were derived from heterogeneous, small populations and... Show moreBackground Non-HLA gene polymorphisms have been shown to influence outcome after allogeneic hematopoietic stem cell transplantation. Results were derived from heterogeneous, small populations and their value remains a matter of debate. Design and Methods In this study, we assessed the effect of single nucleotide polymorphisms in genes for interleukin 1 receptor antagonist (IL1RAI), interleukin 4 (IL4), interleukin 6 (IL6), interleukin 10 (IL10), interferon (IFNG), tumor necrosis factor (TNF) and the cell surface receptors tumor necrosis factor receptor II (TNFRSFIB), vitamin D receptor (VDR) and estrogen receptor alpha (ESR1) in a homogeneous cohort of 228 HLA identical sibling transplants for chronic myeloid leukemia. Three good predictors of overall survival, identified via statistical methods including Cox regression analysis, were investigated for their effects on transplant-related mortality and relapse. Predictive power was assessed after integration into the established European Group for Blood and Marrow Transplantation (EBMT) risk score. Results Absence of patient TNFRSFIB 196R, absence of donor IL10 ATA/ACC and presence of donor IL1RN allele 2 genotypes were associated with increased transplantation-related mortality and decreased survival. Application of prediction error and concordance index statistics gave evidence that integration improved the EBMT risk score. Conclusions Non-HLA genotypes were associated with survival after allogeneic hematopoietic stem cell transplantation. When three genetic polymorphisms were added into the EBMT risk model they improved the goodness of fit. Non-HLA genotyping could, therefore, be used to improve donor selection algorithms and risk assessment prior to allogeneic hematopoietic stem cell transplantation. Show less
Michallet, M.; Dreger, P.; Sutton, L.; Brand, R.; Richards, S.; Biezen, A. van; ... ; Milligan, D. 2010
Background: Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard... Show moreBackground: Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. Methods/Design: Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. Discussion: Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial. Show less
Background: Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as... Show moreBackground: Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis. Methods/Design: Patients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year. Discussion: Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial. Show less
