Purpose On average, 56% of patients report a clinically relevant reduction in pain after lumbar spinal fusion (LSF). Preoperatively identifying which patient will benefit from LSF is paramount to improve clinical decision making, expectation management and treatment selection. Therefore, this multicentre study aimed to develop and validate a clinical prediction tool for a clinically relevant reduction in pain 1 to 2 years after elective LSF. Methods The outcomes were defined as a clinically relevant reduction in predominant (worst reported pain in back or legs) pain 1 to 2 years after LSF. Patient-reported outcome measures and patient characteristics from 202 patients were used to develop a prediction model by logistic regression. Data from 251 patients were used to validate the model. Results Nonsmokers (odds ratio = 0.41 [95% confidence interval = 0.19–0.87]), with lower Body Mass Index (0.93 [0.85–1.01]), shorter pain duration (0.49 [0.20–1.19]), lower American Society of Anaesthesiologists score (4.82 [1.35–17.25]), higher Visual Analogue Scale score for predominant pain (1.05 [1.02–1.08]), lower Oswestry Disability Index (0.96 [0.93–1.00]) and higher RAND-36 mental component score (1.03 [0.10–1.06]) preoperatively had a higher chance of a clinically relevant reduction in predominant pain. The area under the curve of the externally validated model yielded 0.68. A nomogram was developed to aid clinical decision making. Conclusions Using the developed nomogram surgeons can estimate the probability of achieving a clinically relevant pain reduction 1 to 2 years after LSF and consequently inform patients on expected outcomes when considering treatment.
a , on behalf of the Dutch Clinical Spine Research Group à Study Design. in the rest of the article written as patient-and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial. Objective. The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX 1 Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF). Summary of Background Data. Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited. Methods. This study included 100 nontraumatic adults who underwent a primary, single-or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX 1 Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX 1 Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI). Results. There were 49 males and 51 females with a mean age of 55.4 AE 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX 1 Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference ¼ 2.3%, 90% CI ¼ À9.1% to þ13.7%). Conclusion. The results of this noninferiority trial support the use of AttraX 1 Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.
Purpose Based on current scientific evidence and best practice, the first Dutch multidisciplinary practice guideline for occupational health professionals was developed to stimulate prevention and enhance work participation in patients with low back pain (LBP) and lumbosacral radicular syndrome (LRS). Methods A multidisciplinary working group with health care professionals, a patient representative and researchers developed the recommendations after systematic review of evidence about (1) Risk factors, (2) Prevention, (3) Prognostic factors and (4) Interventions. Certainty of the evidence was rated with GRADE and the Evidence to Decision (EtD) framework was used to formulate recommendations. High or moderate certainty resulted in a recommendation “to advise”, low to very low in a recommendation “to consider”, unless other factors in the framework decided differently. Results An inventory of risk factors should be considered and an assessment of prognostic factors is advised. For prevention, physical exercises and education are advised, besides application of the evidence-based practical guidelines “lifting” and “whole body vibration”. The stepped-care approach to enhance work participation starts with the advice to stay active, facilitated by informing the worker, reducing workload, an action plan and a time-contingent increase of work participation for a defined amount of hours and tasks. If work participation has not improved within 6 weeks, additional treatments should be considered based on the present risk and prognostic factors: (1) physiotherapy or exercise therapy; (2) an intensive workplace-oriented program; or (3) cognitive behavioural therapy. After 12 weeks, multi-disciplinary (occupational) rehabilitation therapy need to be considered. Conclusions Based on systematic reviews and expert consensus, the good practice recommendations in this guideline focus on enhancing work participation among workers with LBP and LRS using a stepped-care approach to complement existing guidelines focusing on recovery and daily functioning.
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Study Design. A multicenter, randomized, intrapatient controlled trial. Objective. This study investigated whether lumbar fusion patients blinded to the harvest site (A) can identify the iliac crest used for bone harvesting and (B) whether this iliac crest is more painful than the contralateral side. Summary of Background Data. Spinal fusion with iliac crest autograft is a frequently performed surgical procedure. A widely reported disadvantage of the harvesting procedure is potential donor site morbidity. This has driven the development of many bone graft substitutes. However, more recently the incidence and severity of donor site pain is debated, especially in lumbar fusion surgery. Methods. Ninety-two nontraumatic adult patients underwent a posterolateral (thoraco)lumbar fusion. Iliac crest bone graft was harvested unilaterally through the primary midline incision. At 6 weeks, 3 months, 6 months, and 1 year follow-up, patients were asked to identify the donor site and to rate pain in their back, left iliac crest and right iliac crest on a Visual Analogue Scale (VAS). Results. Ninety patients, 44 males and 46 females with a mean age of 54 years, were analyzed. The left/right distribution of the iliac crest donor site was 50/50 and 89% of the patients underwent a lumbar fusion below L3. Only 24% patients identified the harvest site correctly. Moreover, the VAS pain scores for the donor site and contralateral iliac crest did not differ and were at each timepoint lower than the scores for back pain. Conclusion. This study showed that, during the first year after lumbar fusion surgery via a single midline incision approach, patients could not reliably identify the iliac crest used for bone graft harvesting and this iliac crest was not more painful than the untouched contralateral iliac crest. Therefore, donor site pain should not be the main reason to use bone graft alternatives for lumbar spinal fusion. Level of Evidence: 2
Study Design: Retrospective cohort study. Objective: There is only limited data on the outcome of primary surgery of lumbar disk herniation (LDH) in Dutch patients. The objective of this study is to describe undesirable outcomes after primary LDH. Methods: The National Claims Database (Vektis) was searched for primary LDH operations performed from July 2015 until June 2016, for reoperations within 18 months, prescription of opioids between 6 to 12 months and nerve root block within 1 year. A combined outcome measure was also made. Group comparisons were analyzed with the Student’s t-test. Results: Primary LDH surgery was performed in 6895 patients in 70 hospitals. Weighted mean of reoperations was 7.3%, nerve root block 6.7% and opioid use 15.6%. In total, 23.0% of patients had one or more undesirable outcomes after surgery. The 95% CI interval exceeded the 50% incidence line for 14 out of 26 hospitals with less than 50 surgical interventions per year. Although the data suggested a volume effect on undesired outcomes, the t-tests between hospitals with volume thresholds of 100, 150 and 200 interventions per year did not support this ( P values 0.078, 0.129, 0.114). Conclusion: This unique nationwide claims-based study provides insight into patient-relevant undesirable outcomes such as reoperation, nerve root block and opioid use after LDH surgery. About a quarter of the patients had a serious complication in the first follow up year that prompted further medical treatment. There is a wide variation in complication rates between hospitals with a trend that supports concentration of LDH care.
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