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
The effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy... Show moreThe effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy (including epidural injections) for patients with sciatica due to lumbar disc herniation. A comprehensive search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to October 2009. Randomised controlled trials of adults with lumbar radicular pain, which evaluated at least one clinically relevant outcome measure (pain, functional status, perceived recovery, lost days of work) were included. Two authors assessed risk of bias according to Cochrane criteria and extracted the data. In total, five studies were identified, two of which with a low risk of bias. One study compared early surgery with prolonged conservative care followed by surgery if needed; three studies compared surgery with usual conservative care, and one study compared surgery with epidural injections. Data were not pooled because of clinical heterogeneity and poor reporting of data. One large low-risk-of-bias trial demonstrated that early surgery in patients with 6-12 weeks of radicular pain leads to faster pain relief when compared with prolonged conservative treatment, but there were no differences after 1 and 2 years. Another large low-risk-of-bias trial between surgery and usual conservative care found no statistically significant differences on any of the primary outcome measures after 1 and 2 years. Future studies should evaluate who benefits more from surgery and who from conservative care. 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
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
Eerenbeemt, K.D. van den; Ostelo, R.W.; Royen, B.J. van; Peul, W.C.; Tulder, M.W. van 2010
The objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back... Show moreThe objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the "gold standard" of surgical treatment for DDD. Total disc replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the total disc replacement was compared with lumbar fusion techniques. The Charit, trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charit, artificial disc was non-inferior to the BAK(A (R)) Interbody Fusion System on a composite outcome of "clinical success" (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The Prodisc artificial disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of "clinical success" (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the total disc replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charit, is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectivenes and safety of TDR. Show less
Arts, M.P.; Brand, R.; Akker, E. van den; Koes, B.W.; Peul, W.C. 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
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... 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
The frequently diagnosed lumbar disc herniation can disappear by natural course, but still leads to high low back surgery rates. The optimal period of conservative care, before surgery is executed,... Show moreThe frequently diagnosed lumbar disc herniation can disappear by natural course, but still leads to high low back surgery rates. The optimal period of conservative care, before surgery is executed, was unknown. It is surprising that scientific evidence was lacking which justified “early” surgery. Surgery, after 6-12 weeks of sciatica, was compared to prolonged conservative care in 283 patients in a randomized study. Primary outcomes were perceived recovery, leg pain intensity and functioning. Early surgery resulted in a 2 times faster recovery rate, compared to prolonged conservative care. From the latter group 39 percent of patients could not evade surgery. Within one year, however, both groups presented similar recovery rates and outcome. The impossibility to sit, because of sciatica, seemed to be a good argument to decide for early surgery. Intense pain and disability were predictors for delayed surgery. Compared to men, females exhibited a 3 times higher odds to develop chronic pain. The higher medical costs of early surgery were fully compensated by quick resumption of working capacity. From a medical point of view one may favor a prolonged wait-and-see strategy but our western society urges patients to decide for early surgery to resume daily activities. Show less
Objective: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. Design: Cost utility analysis... Show moreObjective: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. Design: Cost utility analysis alongside a randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with sciatica for 6-12 weeks, caused by lumbar disc herniation. Interventions: Six months of prolonged conservative care compared with early surgery. Main outcome measures: Quality adjusted life years (QALYs) at one year and societal costs, estimated from patient reported utilities (UK and US EuroQol, SF-6D, and visual analogue scale) and diaries on costs (healthcare, patient's costs, and productivity). Results: Compared with prolonged conservative care, early surgery provided faster recovery, with a gain in QALYs according to the UK EuroQol of 0.044 (95% confidence interval 0.005 to 0.083), the US EuroQol of 0.032 (0.005 to 0.059), the SF-6D of 0.024 (0.003 to 0.046), and the visual analogue scale of 0.032 (-0.003 to 0.066). From the healthcare perspective, early surgery resulted in higher costs (difference euro1819 (pound1449; $2832), 95% confidence interval euro842 to euro2790), with a cost utility ratio per QALY of euro41 000 (euro14,000 to euro430 000). From the societal perspective, savings on productivity costs led to a negligible total difference in cost (euro-12, euro-4029 to euro4006). Conclusions: Faster recovery from sciatica makes early surgery likely to be cost effective compared with prolonged conservative care. The estimated difference in healthcare costs was acceptable and was compensated for by the difference in absenteeism from work. For a willingness to pay of euro40,000 or more per QALY, early surgery need not be withheld for economic reasons. Trial registration Current Controlled Trials ISRCTN 26872154. Show less
