Clinical decision making in spinal fusion for chronic low back pain. Results of a nationwide survey among spine surgeons

OBJECTIVES: To assess the use of prognostic patient factors and predictive tests in clinical decision making for spinal fusion in patients with chronic low back pain. DESIGN AND SETTING: Nationwide survey among spine surgeons. PARTICIPANTS: Surgeon members of the Dutch Spine Society were questioned on their treatment strategy for chronic low back pain. PRIMARY AND SECONDARY OUTCOME MEASURES: The surgeons’ opinion on the use of prognostic factors and tests for patient selection were addressed, and the degree of uniformity was assessed. In addition, the influence of surgeon specific factors, such as clinical experience and training, was determined. RESULTS: The comments from 62 surgeons (70% response rate) were analysed. Forty-four surgeons (71%) had extensive clinical experience. There was a statistically significant lack of uniformity of opinion in 7 of the 11 items on prognostic factors and 8 of the 11 items on predictive tests, respectively. Imaging was valued much higher than predictive tests, psychological screening, or patient preferences (all p<0.01). Apart from the use of discography and long multi-segment fusions, differences in training or clinical experience did not appear to be of significant influence on treatment strategy. CONCLUSIONS: The present survey showed a lack of consensus among spine surgeons on the use of predictive tests for patient selection. Prognostic patient factors were not consistently incorporated in their treatment strategy. Clinical decision making for spinal fusion to treat chronic low back pain does not have a uniform evidence base in practice. Future research should focus on identifying subgroups of patients for whom spinal fusion is an effective treatment. Only a reliable prediction of surgical outcome, combined with the implementation of individual patient factors, may enable the instalment of consensus guidelines in surgical decision making for chronic low back pain

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BackgroundThe most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events.Questions/purposes(1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture?MethodsBetween 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death.ResultsPatients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p &lt; 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention.ConclusionAdaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant.Level of EvidenceLevel III, therapeutic study.</p

The Dutch version of the Spinal Appearance Questionnaire for adolescents with idiopathic scoliosis:patient-based cross-cultural adaptation and measurement properties evaluation

Purpose: Adolescent idiopathic scoliosis (AIS) affects the appearance of spine and trunk. The Spinal Appearance Questionnaire (SAQ) assesses the perception of appearance in AIS patients. The aim of this study is to translate and culturally adapt the recommended short version of the SAQ into Dutch and to test its measurement properties. Methods: A Dutch SAQ (14-item; appearance and expectations domains) was developed following guidelines for translation and cross-cultural adaptation. The COSMIN Study Design checklist was used for measurement properties evaluation. In this multicenter study, the Dutch SAQ, SRS-22R and NPRS (back pain) were administered to 113 AIS patients (aged 15.4 years [SD 2.2], 21.2% male). Floor and ceiling effects were evaluated for content analysis. For reliability, internal consistency (Cronbach’s alpha) and test–retest reliability (ICC; n = 34) were evaluated. Predefined hypotheses of relationships with other questionnaires and between subgroups based on scoliosis severity (radiological and clinical) were tested for construct validity. Exploratory factor analysis (EFA) was performed to investigate the validity of the underlying structure of this 14-item questionnaire. Results: No floor and ceiling effects were found for domains and total scores. Cronbach’s alpha ranged from 0.84 to 0.89. ICCs varied from 0.76 to 0.77. For construct validity, 89% (8/9) of the predefined hypotheses were confirmed. Significant higher scores for the appearance domain were found for subgroups based on radiological (Cobb angle; &gt; 25.0°) and clinical outcomes. (Angle of Trunk Rotation; &gt; 9.0°). A two-factor structure was found (EV 5.13; 36.63% explained variance). Conclusion: The Dutch SAQ is an adequate, valid and reliable instrument to evaluate patients’ perception of appearance in AIS. Level of evidence: Level I—diagnostic studies.</p

Screening for adolescent idiopathic scoliosis: an information statement by the scoliosis research society international task force

Background: Routine screening of scoliosis is a controversial subject and screening efforts vary greatly around the world. METHODS: Consensus was sought among an international group of experts (seven spine surgeons and one clinical epidemiologist) using a modified Delphi approach. The consensus achieved was based on careful analysis of a recent critical review of the literature on scoliosis screening, performed using a conceptual framework of analysis focusing on five main dimensions: technical, clinical, program, cost and treatment effectiveness. FINDINGS: A consensus was obtained in all five dimensions of analysis, resulting in 10 statements and recommendations. In summary, there is scientific evidence to support the value of scoliosis screening with respect to technical efficacy, clinical, program and treatment effectiveness, but there insufficient evidence to make a statement with respect to cost effectiveness. Scoliosis screening should be aimed at identifying suspected cases of scoliosis that will be referred for diagnostic evaluation and confirmed, or ruled out, with a clinically significant scoliosis. The scoliometer is currently the best tool available for scoliosis screening and there is moderate evidence to recommend referral with values between 5 degrees and 7 degrees. There is moderate evidence that scoliosis screening allows for detection and referral of patients at an earlier stage of the clinical course, and there is low evidence suggesting that scoliosis patients detected by screening are less likely to need surgery than those who did not have screening. There is strong evidence to support treatment by bracing. INTERPRETATION: This information statement by an expert panel supports scoliosis screening in 4 of the 5 domains studied, using a framework of analysis which includes all of the World Health Organisation criteria for a valid screening procedure.IRSC (MOP864910

Lumbar spine segmentation in MR images: a dataset and a public benchmark

This paper presents a large publicly available multi-center lumbar spine magnetic resonance imaging (MRI) dataset with reference segmentations of vertebrae, intervertebral discs (IVDs), and spinal canal. The dataset includes 447 sagittal T1 and T2 MRI series from 218 patients with a history of low back pain. It was collected from four different hospitals and was divided into a training (179 patients) and validation (39 patients) set. An iterative data annotation approach was used by training a segmentation algorithm on a small part of the dataset, enabling semi-automatic segmentation of the remaining images. The algorithm provided an initial segmentation, which was subsequently reviewed, manually corrected, and added to the training data. We provide reference performance values for this baseline algorithm and nnU-Net, which performed comparably. We set up a continuous segmentation challenge to allow for a fair comparison of different segmentation algorithms. This study may encourage wider collaboration in the field of spine segmentation, and improve the diagnostic value of lumbar spine MRI

Bracing patients with idiopathic scoliosis: Design of the Dutch randomized controlled treatment trial

Background. The effectiveness of bracing patients with IS has not yet been convincingly established due to a lack of RCTs. Some authors suggest that their results confirm that bracing is effective; others conclude that the effectiveness of bracing is doubtful or recommend a RCT. The aim of this study was to establish whether bracing patients with idiopathic scoliosis (IS) in an early stage will result in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow-up. Methods. A randomized controlled trial was designed. Eligible patients are girls and boys in the age group 8-15 years whose diagnosis of IS has been established by an orthopedic surgeon, who have not yet been treated by bracing or surgery, and for whom further growth of physical height is still expected based on medical examination and maturation characteristics (Risser ? 2). The Cobb angle of the eligible patient should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees, or should be minimally 30 and maximally 35 degrees; established progression for the latter is not necessary. A total of 100 patients will be included in this trial. The intervention group will be treated with full-time Boston brace wear; the control group will not be braced. Every four months, each patient will have a physical and an X-ray examination. The main outcomes will be the Cobb angle two years after inclusion and health-related quality of life. Discussion. The results of this trial will be of great importance for the discussion on early treatment for scoliosis. Furthermore, the result will also be important for screening for scoliosis policies. Trial registration. Nederlands Trialregister ISRCTN36964733

The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study

STUDY DESIGN: Multicenter, international prospective study. OBJECTIVE: This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status. METHODS: As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID. RESULTS: The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29). CONCLUSIONS: The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively

Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management

Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen’s d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes

Data from: Clinical decision making in spinal fusion for chronic low back pain. Results of a nationwide survey among spine surgeons

OBJECTIVES: To assess the use of prognostic patient factors and predictive tests in clinical decision making for spinal fusion in patients with chronic low back pain. DESIGN AND SETTING: Nationwide survey among spine surgeons. PARTICIPANTS: Surgeon members of the Dutch Spine Society were questioned on their treatment strategy for chronic low back pain. PRIMARY AND SECONDARY OUTCOME MEASURES: The surgeons’ opinion on the use of prognostic factors and tests for patient selection were addressed, and the degree of uniformity was assessed. In addition, the influence of surgeon specific factors, such as clinical experience and training, was determined. RESULTS: The comments from 62 surgeons (70% response rate) were analysed. Forty-four surgeons (71%) had extensive clinical experience. There was a statistically significant lack of uniformity of opinion in 7 of the 11 items on prognostic factors and 8 of the 11 items on predictive tests, respectively. Imaging was valued much higher than predictive tests, psychological screening, or patient preferences (all p<0.01). Apart from the use of discography and long multi-segment fusions, differences in training or clinical experience did not appear to be of significant influence on treatment strategy. CONCLUSIONS: The present survey showed a lack of consensus among spine surgeons on the use of predictive tests for patient selection. Prognostic patient factors were not consistently incorporated in their treatment strategy. Clinical decision making for spinal fusion to treat chronic low back pain does not have a uniform evidence base in practice. Future research should focus on identifying subgroups of patients for whom spinal fusion is an effective treatment. Only a reliable prediction of surgical outcome, combined with the implementation of individual patient factors, may enable the instalment of consensus guidelines in surgical decision making for chronic low back pain