Design of the PROCON trial: a prospective, randomized multi – center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN4168184

Evidence for surgery in degenerative lumbar spine disorders

We aimed to evaluate the available evidence on the effectiveness of surgical interventions for a number of conditions resulting in low back pain (LBP) or spine-related irradiating leg pain. We searched the Cochrane databases and PubMed up to June 2013. We included systematic reviews and randomised controlled trials (RCTs) on degenerative disc disease (DDD), herniated disc, spondylolisthesis and spinal stenosis due to degenerative osteoarthritis. We included comparisons between surgery and conservative care and between different techniques. The quality of the systematic reviews was evaluated using assessment of multiple systematic reviews (AMSTAR). Twenty systematic reviews were included which covered the following diagnoses: disc herniation (n = 9), spondylolisthesis (n = 2), spinal stenosis (n = 3), DDD (n = 4) and combinations (n = 2). For most of the comparisons, no significant and/or clinically relevant differences between interventions were identified. In general, surgery is only indicated for relief of leg pain in clear indications such as disc herniation, spondylolisthesis or spinal stenosis. (C) 2013 Published by Elsevier Ltd

Recovery of motor deficit accompanying sciatica-subgroup analysis of a randomized controlled trial

BACKGROUND CONTEXT: In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit. PURPOSE: The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment. STUDY DESIGN: Subgroup analysis of a randomized controlled trial. PATIENT SAMPLE: This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit. OUTCOME MEASURES: Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale. METHODS: In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague. RESULTS: Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p = .01), but the difference was no longer significant at 26 (p = .21) or 52 weeks (p = .92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing >= 25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year. CONCLUSIONS: Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year. (C) 2014 Elsevier Inc. All rights reserved

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomised controlled trial

STUDY QUESTION Is interspinous process device implantation more effective in the short term (eight weeks) than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis? SUMMARY ANSWER The use of interspinous implants did not result in a better outcome than conventional decompression, but the reoperation rate was significantly higher. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Bony decompression and treatment with interspinous process devices are superior to conservative and non-surgical treatment for intermittent neurogenic claudication due to lumbar spinal stenosis. Interspinous implants surgery is not superior to bony decompression, and the reoperation rate is significantly higher

IPD without bony decompression versus conventional surgical decompression for lumbar spinal stenosis: 2-year results of a double-blind randomized controlled trial

Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden-The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57-78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48-71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p < 0.01). Furthermore, long-term VAS back pain was significantly higher [36 mm on a 100 mm scale (95 % CI 24-48)] in the IPD group compared to the bony decompression group [28 mm (95 % CI 23-34) p value 0.04]. This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional 'simple' decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm