Measuring quality of recovery (QoR-15) after degenerative spinal surgery: A prospective observational study.

Introduction: The Quality of Recovery (QoR-15) score evaluates patient's recovery after surgery and anesthesia. There is a lack of studies focusing on the patients' quality of recovery in the early post-discharge phase after elective lumbar spine surgery. Research question: We aimed to identify the QoR-15 score in patients who underwent surgery for degenerative low back conditions. Furthermore, we aimed to identify the individual items of the QoR-15 that are crucial for the patients' quality of recovery. Material and methods: The study was conducted at a spine center in Denmark from December 2021 to September 2022. Data were collected, using a mobile health application, preoperatively and at 3 time points after hospital discharge. Descriptive analysis followed by within-subjects longitudinal repeated measures was conducted. The individual items of the QoR-15 score were explored using a heatmap. Results: Data from 46 patients were analysed. The mean QoR-15 sum score at baseline was 105.4 ± 18.3. The mean QoR-15 sum scores were 108.1 ± 19.2 on post-discharge day 1, 118.5 ± 17.4 on day 7, and 120.7 ± 20.9 on day 14. The mean QoR-15 score from day 1 to day 7 improved significantly. Eight of the 15 items influenced the overall QoR-15 score. Discussion and conclusion: This study applied the QoR-15 score in lumbar spine surgery patients. We identified specific items from the QoR-15 scale that are crucial to improving patients' recovery after hospital discharge. Further research is needed to identify specific needs in the post-discharge period in this group of patients.

Rate of Unexpected Malignancy in Patients Undergoing Percutaneous Vertebroplasty after Implementing a New Scanning Protocol.

STUDY DESIGN: Retrospective quality improvement study. OBJECTIVE: To investigate if the rate of unsuspected malignancy in biopsies in patients with VCF who underwent PVP at the same orthopedic department has changed after implementation of a new MRI scanning protocol. SUMMARY OF BACKGROUND DATA: Discrimination between benign and malign vertebral compression fracture (VCF) can be difficult. However, early diagnosis of malignant VCF is crucial to further treatment and prognosis. An earlier study at an orthopedic department reported a rate of unsuspected malignancy of 4.9% in patients with VCF who underwent percutaneous vertebroplasty (PVP) when biopsies were obtained during the procedure. MRI scanning protocol was changed in this period. METHODS: Retrospective on 427 patients with vertebral compression fracture undergoing PVP from 28th of April 2017 to 28th of April 2022, identifying operated patients from the Danish national DaneSpine registry. Subsequently, individual clinical information was collected in journal records. RESULTS: The rate of unsuspected malignancy was 0.9% (4/427) and the overestimation of malignant VCF was 50% (16/32). CONCLUSION: During the last 5 years, the rate of unsuspected malignancy in patients with VCF undergoing PVP has improved considerably from 4.9% to 0.9%. Furthermore, MRI is over-diagnosing malignancies. Thus, the new scanning procedure is effective in differentiating between benign and malign VCFs. LEVEL OF EVIDENCE: 3.

Performance of the streamlined quality outcomes database web-based calculator: internal and external validation.

BACKGROUND CONTEXT: With an increasing number of web-based calculators designed to provide the probabilities of an individual achieving improvement after lumbar spine surgery, there is a need to determine the accuracy of these models. PURPOSE: To perform an internal and external validation study of the reduced Quality Outcomes Database web-based Calculator (QOD-Calc). STUDY DESIGN: Observational longitudinal cohort. PATIENT SAMPLE: Patients enrolled study-wide in Quality Outcomes Database (QOD) and patients enrolled in DaneSpine at a single institution who had elective lumbar spine surgery with baseline data to complete QOD-Calc and 12-month postoperative data. OUTCOME MEASURES: Oswestry Disability Index (ODI), Numeric Rating Scales (NRS) for back and leg pain, EuroQOL-5D (EQ-5D). METHODS: Baseline data elements were entered into QOD-Calc to determine the probability for each patient having Any Improvement and 30% Improvement in NRS leg pain, back pain, EQ-5D and ODI. These probabilities were compared with the actual 12-month postop data for each of the QOD and DaneSpine cases. Receiver-operating characteristics analyses were performed and calibration plots created to assess model performance. RESULTS: 24,755 QOD cases and 8,105 DaneSpine lumbar cases were included in the analysis. QOD-Calc had acceptable to outstanding ability (AUC: 0.694-0.874) to predict Any Improvement in the QOD cohort and moderate to acceptable ability (AUC: 0.658-0.747) to predict 30% Improvement. QOD-Calc had acceptable to exceptional ability (AUC: 0.669-0.734) to predict Any improvement and moderate to exceptional ability (AUC: 0.619-0.862) to predict 30% Improvement in the DaneSpine cohort. AUCs for the DaneSpine cohort was consistently lower that the AUCs for the QOD validation cohort. CONCLUSION: QOD-Calc performs well in predicting outcomes in a patient population that is similar to the patients that was used to develop it. Although still acceptable, model performance was slightly worse in a distinct population, despite the fact that the sample was more homogenous. Model performance may also be attributed to the low discrimination threshold, with close to 90% of cases reporting Any Improvement in outcome. Prediction models may need to be developed that are highly specific to the characteristics of the population.

Stand-alone ALIF versus TLIF in patients with low back pain - A propensity-matched cohort study with two-year follow-up.

Introduction: Instrumented lumbar fusion by either the anterior or transforaminal approach has different advantages and disadvantages. Few studies have compared PatientReported Outcomes Measures (PROMs) between stand-alone anterior lumbar interbody fusion (SA-ALIF) and transforaminal lumbar interbody fusion (TLIF). Research question: This is a register-based dual-center study on patients with severe disc degeneration (DD) and low back pain (LBP) undergoing single-level SA-ALIF or TLIF. Comparing PROMs, including disability, quality of life, back- and leg-pain and patient satisfaction two years after SA-ALIF or TLIF, respectively. Material and methods: Data were collected preoperatively and at one and two-year follow-up. The primary outcome was Oswestry Disability Index (ODI). The secondary outcomes were patient satisfaction, walking ability, visual analog scale (VAS) scores for back and leg pain, and quality of life (QoL) measured by the European Quality of Life-5 Dimensions (EQ-5D) index score. To reduce baseline differences between groups, propensity-score matching was employed in a 1:1 fashion. Results: 92 patients were matched, 46 S A-ALIF and 46 TLIF. They were comparable preoperatively, with no significant difference in demographic data or PROMs (P > 0.10). Both groups obtained statistically significant improvement in the ODI, QoL and VAS-score (P < 0.01), but no significant difference was observed (P = 0.14). No statistically significant differences in EQ-5D index scores (P = 0.25), VAS score for leg pain (P = 0.88) and back pain (P = 0.37) at two years follow-up. Conclusion: Significant improvements in ODI, VAS-scores for back and leg pain, and EQ-5D index score were registered after two-year follow-up with both SA-ALIF and TLIF. No significant differences in improvement.

Impact of Preoperative Duration of Symptoms on Patient Satisfaction, Outcomes and Complications After Lumbar Discectomy: A Propensity-matched Comparison.

STUDY DESIGN: Observational study. OBJECTIVE: To identify associations between preoperative symptom duration and postoperative patient satisfaction. SUMMARY OF BACKGROUND DATA: Sciatica due to lumbar disk herniation (LDH) is a cause of disability and reduced quality life. Patients with severe pain and disability or were recovery is unacceptably slow, surgical intervention can be advised. For these patients, evidence-based recommendations on the timing of the surgical intervention needs to be established. METHODS: All patients who underwent discectomy at a Spine Centre, due to radicular pain from June 2010 to May 2019 were included. Pre- and postoperative data including demographic data, smoking, consumption of pain medication, comorbidity, back and leg-pain, health-related quality of life as measured by EQ-5D, ODI, previous spine surgery, sick leave, and duration of back and leg-pain before surgery were utilized. The patients were divided into four groups based on their self-reported duration of leg-pain before surgery. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on all reported preoperative factors. RESULTS: Of 1607 patients undergoing lumbar discectomy, four matched cohorts based on their self-reported duration of leg-pain before surgery were created. Each cohort consisted of 150 patients well balanced on preoperative factors. Overall 62.7% of the patients were satisfied with the surgical result ranging from 74.0% in the <3 months group to 48.7% in the >24 months group ( P <0.000). The portion of patients achieving a minimum clinically important difference for EQ-5D decreased from 77.4% with early intervention to 55.6% in the late group ( P <0.000). The number of surgical complications were not affected by the duration of preoperative leg-pain. CONCLUSION: We found significant difference in patient satisfaction and health-related quality of life in patients related to the duration of preoperative leg-pain due to symptomatic LDH. LEVEL OF EVIDENCE: 3.

Radiological Definitions of Sagittal Plane Segmental Instability in the Degenerative Lumbar Spine - A Systematic Review.

STUDY DESIGN: Systematic Review. OBJECTIVE: To collect and group definitions of segmental instability, reported in surgical studies of patients with lumbar spinal stenosis (LSS) and/or lumbar degenerative spondylolisthesis (LDS). To report the frequencies of these definitions. To report on imaging measurement thresholds for instability in patients and compare these to those reported in biomechanical studies and studies of spine healthy individuals.To report on studies that include a reliability study. METHODS: This review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Studies eligible for inclusion were clinical and biomechanical studies on adult patients with LDS and/or LSS who underwent surgical treatment and had data on diagnostic imaging. A systematic literature search was conducted in relevant literature databases. Full text screening inclusion criteria was definition of segmental instability or any synonym. Two reviewers independently screened articles in a two-step process. Data synthesis presented by tabulate form and narrative synthesis. RESULTS: We included 118 studies for data extraction, 69% were surgical studies with decompression or fusion as interventions, 31% non-interventional studies. Grouping the definitions of segmental instability according similarities showed that 24% defined instability by dynamic sagittal translation, 26% dynamic translation and dynamic angulation, 8% used a narrative definition. Comparison showed that non-interventional studies with a healthy population more often had a narrative definition. CONCLUSION: Despite a reputation of non-consensus, segmental instability in the degenerative lumbar spine can radiologically be defined as > 3 mm dynamic sagittal translation.

The Clinical Significance of the Modic Changes Grading Score.

STUDY DESIGN: Cross-sectional retrospective observational study. OBJECTIVE: To evaluate the reliability and clinical utility of the Modic changes (MC) grading score. METHOD: Patients from the Danish national spine registry, DaneSpine, scheduled for lumbar discectomy were identified. MRI of patients with MC were graded based on vertical height involvement: Grade A (<25%), Grade B (25%-50%), and Grade C (>50%). All MRIs were reviewed by 2 physicians to evaluate the reliability of the MC grade. RESULTS: Of 213 patients included, 142 patients had MC, 71 with MC-1 and 71 with MC-2; 34% were Grade A, 45% were Grade B, and 21% were Grade C. MC grade demonstrated substantial intra-rater (κ = .68) and inter-rater (κ = .61) reliability. A significantly higher proportion (n = 40, 57%) of patients with MC-1 had a severe MC grade compared to patients with MC-2 (n = 30, 43%, P < .001). Severe MC grade was associated with the presence of severe lumbar disc degeneration (DD) (Pfirrmann grade = V, P = .024), worse preoperative ODI (52.49 vs 44.17, P = .021) and EQ-5D scores (.26 vs .46, P = .053). MC alone including type was not associated with a significant difference in patient-reported outcomes (P > .05). CONCLUSION: The MC grade score was demonstrated to have substantial intra- and inter-observer reliability. Severe MC grade was associated with both severe DD and MC type, being more prevalent in patients with MC-1. The MC grade was also significantly associated with worse disability and reduced health-related quality of life. Results from the study suggest that MC grade is more clinically important than MC type.

Predictive Factors of Successful Return to Work Following Discectomy.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: To identify modifiable factors associated with successful return to work 12 weeks following discectomy. Lumbar disc herniation is a common cause of sciatica and sick leave. This presents an economic burden to the individual and the society. METHODS: Data from DaneSpine on a consecutive cohort of patients operated due to lumbar disc herniation during a 3-year period was identified and merged with data from the Ministry of Employment's register on public welfare payments. Data on welfare payments 2 years prior to the date of operation and 1 year postoperative was included. Patients were considered to be on sick leave if they received welfare payments for the week. Patients are considered to have returned to work if they did not receive public welfare payments for a 4-week period. RESULTS: Of 1134 patients meeting inclusion criteria, 98.5% had complete preoperative surgical data available. Postoperatively, 79.1% of the patients returned to the work within 12 weeks. Physically demanding jobs, low preoperative EQ5D score, and long duration of sick leave prior to surgery were associated negatively with return to work at 12 weeks. CONCLUSION: The results of this study indicate that patients who have a longer duration of sick leave have a physically demanding job and are in a poor health are more likely not to return to work by 12 weeks after surgery for lumbar disc herniation. Future studies are needed to determine if earlier referral to a surgeon leads to an earlier return to work.

Clinical and Patient-reported Outcomes After Posterior Versus Transforaminal Lumbar Interbody Fusion-A Propensity Score-matched Cohort Study on 422 Patients with 2-year Follow-up.

STUDY DESIGN: This was a dual-center study over an eight-year period on patients undergoing single level fusion surgery with either posterior- (PLIF) or transforaminal lumbar interbody fusion (TLIF). We analyzed prospectively collected pre- and postoperative data from the national Danish surgical spine database (DaneSpine). OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcome (PRO) 2 years after TLIF or PLIF in patients with symptomatic lumbar mechanical disc degeneration. SUMMARY OF BACKGROUND DATA: PLIF and TLIF are well-described techniques for treating lumbar mechanical disc degeneration but whether the theoretical differences between the two techniques translate to different clinical outcomes is unknown. METHODS: The primary outcome was Oswestry Disability Index (ODI) score at 2-year follow-up. Secondary outcome measures were scores on the European Quality of Life-5 Dimensions (EQ-5D) and visual analog scale (VAS) and the rate of intraoperative complications. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on preoperative factors including age, sex, back and leg pain, ODI, EQ-5D, and previous spine surgery. RESULT: The matched cohort included 211 patients in each cohort. There was no significant difference between the groups in the mean score on the ODI at two years (PLIF: 33 ±â€Š20 vs. TLIF: 35 ±â€Š20, P = 0.328). We found no statistically significant differences in EQ-5D score (0.54 ±â€Š0.35 vs. 0.51 ±â€Š0.34, P = 0.327), VAS score for back pain (47 ±â€Š32 vs. 48 ±â€Š29, P = 0.570) or leg pain (42 ±â€Š33 vs. 41 ±â€Š32, P = 0.936) between the PLIF and TLIF groups, respectively, at 2-year follow-up. Dural tears occurred in 9.5% in the PLIF group and 1.9% in the TLIF group (P = 0.002) corresponding to a relative risk of 5.0 (95% CI 1.7-14.4). CONCLUSION: We found no significant difference in PRO at 2-year follow-up between PLIF and TLIF for the treatment of lumbar disc degeneration. PLIF is associated with a five times higher risk of dural tears.Level of Evidence: 3.

Coccydynia-The Efficacy of Available Treatment Options: A Systematic Review.

STUDY DESIGN: Systematic Review. OBJECTIVE: To evaluate the efficacy of available treatment options for patients with persistent coccydynia through a systematic review. METHODS: Original peer-reviewed publications on treatment for coccydynia were identified using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines by performing a literature search of relevant databases, from their inception to January 17, 2020, combined with other sources. Data on extracted treatment outcome was pooled based on treatment categories to allow for meta-analysis. All outcomes relevant to the treatment efficacy of coccydynia were extracted. No single measure of outcome was consistently present among the included studies. Numeric Rating Scale, (NRS, 0-10) for pain was used as the primary outcome measure. Studies with treatment outcome on adult patients with chronic primary coccydynia were considered eligible. RESULTS: A total of 1980 patients across 64 studies were identified: five randomized controlled trials, one experimental study, one quasi-experimental study, 11 prospective observational studies, 45 retrospective studies and unpublished data from the DaneSpine registry. The greatest improvement in pain was achieved by patients who underwent radiofrequency therapy (RFT, mean Visual Analog Scale (VAS) decreased by 5.11 cm). A similar mean improvement was achieved from Extracorporeal Shockwave Therapy (ESWT, 5.06), Coccygectomy (4.86) and Injection (4.22). Although improved, the mean change was less for those who received Ganglion block (2.98), Stretching/Manipulation (2.19) and Conservative/Usual Care (1.69). CONCLUSION: This study highlights the progressive nature of treatment for coccydynia, starting with noninvasive methods before considering coccygectomy. Non-surgical management provides pain relief for many patients. Coccygectomy is by far the most thoroughly investigated treatment option and may be beneficial for refractory cases. Future randomized controlled trials should be conducted with an aim to compare the efficacy of interventional therapies amongst each other and to coccygectomy.

Phenotypic heterogeneity and mosaicism in Xia-Gibbs syndrome: Five Danish patients with novel variants in AHDC1.

Xia-Gibbs syndrome (XGS) is a neurodevelopmental disorder characterized by intellectual disability, developmental delay, seizures, hypotonia, obstructive sleep apnoea and mild facial dysmorphism. Heterozygosity for loss-of-function variants in AHDC1, encoding the AT-hook DNA binding motif containing protein 1, were discovered in 2014 as the likely genetic cause of Xia-Gibbs syndrome. We present five patients with Xia-Gibbs syndrome caused by previously unreported variants in AHDC1. Two of the patients share a frameshift variant: c.2849del (p.(Pro950Argfs*192)) in AHDC1. Despite sharing this variant, the two patients show remarkable phenotypic differences underscoring the clinical heterogeneity of Xia-Gibbs syndrome. In addition, we present a case of Xia-Gibbs syndrome caused by mosaicism for an AHDC1 variant.

The efficacy of coccygectomy in patients with persistent coccydynia.

AIMS: The aim of this study was to investigate the efficacy of coccygectomy in patients with persistent coccydynia and coccygeal instability. METHODS: The Danish National Spine Registry, DaneSpine, was used to identify 134 consecutive patients who underwent surgery, performed by a single surgeon between 2011 and 2019. Routine demographic data, surgical variables, and patient-reported outcomes, including a visual analogue scale (VAS) (0 to 100) for pain, Oswestry Disability Index (ODI), EuroQol five-dimension questionnaire (EQ-5D), and the Physical Component Score (PCS) and Mental Component Score (MCS) of the 36-Item Short-Form Health Survey questionnaire (SF-36) were collected at baseline and one-year postoperatively. RESULTS: A total of 112 (84%) patients with a minimum follow-up of one year had data available for analysis. Their mean age was 41.9 years, and 15 (13%) were males. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for the mean VAS for pain (70.99 to 35.34), EQ-5D (0.52 to 0.75), ODI (31.84 to 18.00), and SF-36 PCS (38.17 to 44.74). A total of 78 patients (70%) were satisfied with the outcome of treatment. CONCLUSION: Patients with persistent coccydynia and coccygeal instability resistant to nonoperative treatment may benefit from coccygectomy. Cite this article: Bone Joint J 2021;103-B(3):542-546.

The heritability of coronal and sagittal phenotype in idiopathic scoliosis: a report of 12 monozygotic twin pairs.

PURPOSE: One of the pathways through which genetics may act in the causation of idiopathic scoliosis is inheritance of a specific sagittal profile that predisposes for its development. In this study, coronal and sagittal parameters were compared in an international collection of monozygotic twins with idiopathic scoliosis. METHODS: Twelve monozygotic twin pairs who underwent biplanar radiography for idiopathic scoliosis were systematically identified in existing scoliosis databases in The Netherlands, Sweden, and Denmark. On the first available radiographs, the coronal and sagittal curve parameters (Roussouly and Abelin types, thoracic kyphosis, lumbar lordosis and length of the posteriorly inclined segment) were determined. RESULTS: In all 12 monozygotic twin pairs, both twins were affected by AIS. Four (33%) twin pairs had similar coronal and sagittal spinal phenotype, whereas two (17%) had different coronal phenotype and similar sagittal profiles, and six (50%) pairs had different coronal as well as sagittal phenotype. CONCLUSIONS: Analysis of biplanar curve characteristics in monozygotic twins showed that all twin pairs were affected by idiopathic scoliosis. However, only 33% of the pairs had similar coronal and sagittal spinal phenotypes. Based on this limited dataset, the hypothesis can be formulated that besides genetic pre-disposition, the individual (inherited) sagittal profile plays a role in the development of different coronal curve type.

Is the Hospital Anxiety and Depression Scale Associated With Outcomes After Lumbar Spine Surgery?

STUDY DESIGN: Longitudinal cohort. OBJECTIVES: The Hospital Anxiety and Depression Scale (HADS) was developed to provide clinicians a reliable, valid, and practical tool to identify and quantify the anxiety and depression in medical patients. Several studies have shown that patients with chronic low back pain may have subclinical depression and impairments in mental health and that these in turn may lead to less than optimal results after lumbar spine surgery. The purpose of this study is to determine if there are associations between preoperative HADS and differences in pre- and postoperative health-related quality-of-life (HRQOLs) scores after spine surgery. METHODS: From a single center, a consecutive series of patients completed the HADS, Oswestry Disability Index (ODI), Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and Visual Analog Scale (VAS) for back and leg pain. Except for HADS, the patients completed the same HRQOLs 1 year after surgery. RESULTS: Of 308 eligible cases, 208 (68%) had follow-up data available and were included in the analysis. Patients in the HADS-Anxiety (HADS-A) Abnormal category had the worst preoperative HRQOLs but had the greatest improvement in 1-year postoperative scores. Except for VAS Leg Pain, preoperative HRQOLs were better in patients in the HADS-Depressed (HADS-D) Normal category. Patients in the HADS-D Abnormal category had statistically significantly greater improvement in 1-year postoperative EQ-5D and ODI scores when compared with the other cohorts. CONCLUSION: Worse HADS-A and HADS-D scores are associated with worse preoperative HRQOL scores in patients with lumbar degenerative disorders scheduled for spine surgery. However, similar improvements in HRQOLs can be expected 1 year postoperative regardless of the patients' HADS scores.

Percutaneous vertebroplasty as treatment of malignant vertebral lesions: a systematic review and GRADE evaluation resulting in a Danish national clinical guideline.

PURPOSE: To summarize the recommendations from the national clinical guideline published by the Danish Health Authority, regarding cemental augmentation as treatment for painful vertebral lesions, in patients with malignant disease. METHODS: A multidisciplinary working group formulated recommendations based on the GRADE approach. RESULTS: Two of the questions were based on randomized studies and one on professional consensus. The guideline recommends cemental augmentation for painful vertebral lesions in patients with malignant diagnosis, either hematological or non-hematological. Fracture of the posterior wall is not a contradiction to cemental augmentation, but care should always be taken while injecting the cement, to decrease the risk of cemental leaks into the spinal canal. CONCLUSION: The recommendations are based on low-to-moderate quality of evidence or professional consensus as well as patient preferences and positive and harmful effects of the intervention. The working group recommends more randomized studies on patients with different malignant diseases and painful vertebral lesions comparing percutaneous vertebroplasty/kyphoplasty and conservative treatment to confirm the conclusion in this guideline. These slides can be retrieved under Electronic Supplementary Material.

Fusion and Healing Prediction in Posterolateral Spinal Fusion Using 18F-Sodium Fluoride-PET/CT.

This study measures the total graft of 18F-sodium fluoride (NaF) uptake in non-instrumented posterolateral lumbar fusion (niPLF) patients one month after surgery and correlates it with the difference in the clinical findings between the baseline and one year after surgery. The walking distance (WLK-D), visual analog scale of back pain (VAS-B), VAS score of leg pain (VAS-L), tandem test (TAN), Oswestry Disability Index questionnaire (ODI), and European Quality of Life-5 Dimensions questionnaire (EQ-5D) were assessed before surgery and one year after. The graft NaF uptake was analyzed quantitatively with a fixed threshold algorithm resulting in the total graft uptake (SUVtotal) and partial volume corrected SUVtotal (cSUVtotal). Only 4 out of 18 patients experienced fusion; they had an insignificantly lower median total graft uptakes, i.e., 1178 SUVtotal vs. 1224 SUVtotal (p = 0.73) and 1282 cSUVtotal vs. 1231 cSUVtotal (p = 0.35), respectively. Similarly, fused patients experienced insignificantly larger pain decreases, i.e., median VAS-B 4.3 vs. 3.8 (p = 0.92) and VAS-L -6.4 vs. -4.4 (p = 0.2). We found an insignificant trend for a lower NaF uptake and less pain in fused patients. The NaF uptake did not correlate with the chronological change in the clinical parameters.

Percutaneous vertebroplasty as treatment of malignant vertebral lesions: a systematic review and GRADE evaluation resulting in a Danish national clinical guideline

To summarize the recommendations from the national clinical guideline published by the Danish Health Authority, regarding cemental augmentation as treatment for painful vertebral lesions, in patients with malignant disease. A multidisciplinary working group formulated recommendations based on the GRADE approach. Two of the questions were based on randomized studies and one on professional consensus. The guideline recommends cemental augmentation for painful vertebral lesions in patients with malignant diagnosis, either hematological or non-hematological. Fracture of the posterior wall is not a contradiction to cemental augmentation, but care should always be taken while injecting the cement, to decrease the risk of cemental leaks into the spinal canal. The recommendations are based on low-to-moderate quality of evidence or professional consensus as well as patient preferences and positive and harmful effects of the intervention. The working group recommends more randomized studies on patients with different malignant diseases and painful vertebral lesions comparing percutaneous vertebroplasty/kyphoplasty and conservative treatment to confirm the conclusion in this guideline. These slides can be retrieved under Electronic Supplementary Material.

Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery.

BACKGROUND CONTEXT: Due to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery. PURPOSE: To evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft. STUDY DESIGN: Double-blind randomized clinical trial. PATIENT SAMPLE: Patients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion. OUTCOME MEASURES: Visual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D. METHODS: One hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as "fusion" or "no fusion." RESULTS: There were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups. CONCLUSIONS: Patients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.

Cost-effectiveness of postoperative rehabilitation after surgery for lumbar disc herniation: an analysis based on a randomized controlled trial.

OBJECTIVE: The aim of this study was to examine whether routine referral to municipal postoperative rehabilitation is cost-effective in comparison to no referral after surgery for lumbar disc herniation (LDH). METHODS: One hundred forty-six patients scheduled for primary discectomy due to LDH were included. This secondary analysis, based on data from a previous randomized controlled trial, compared costs and quality-adjusted life years (QALYs) between two groups of patients recovering from LDH surgery: one group of patients received a referral for municipal physical rehabilitation (REHAB) and the other group was sent home without a referral to any postoperative rehabilitation (HOME). Primary outcomes were QALYs calculated from the EQ-5D utility score, societal costs, and incremental cost-effectiveness ratios (ICERs). The main cost-effectiveness analysis used intention-to-treat data, whereas sensitivity analyses included as-treated data. Questionnaires were collected after 1, 3, 6, 12, and 24 months postoperatively. RESULTS: The main cost-effectiveness analysis showed a small, insignificant incremental QALY of 0.021 and an incremental cost of €211.8 for the REHAB group compared to the HOME group, resulting in an ICER of €10,085. In the as-treated sensitivity analysis, the REHAB group had poorer outcomes and higher costs compared to the HOME group. CONCLUSIONS: Routine referral to municipal physical rehabilitation in patients recovering from LDH surgery was not cost-effective compared to no referral.Clinical trial registration no.: NCT03505918 (clinicaltrials.gov).