Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial.

INTRODUCTION Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER NCT02763956. PROTOCOL VERSION 7.1, 18 November 2020

The effect of perioperative psychological interventions on persistent pain, disability, and quality of life in patients undergoing spinal fusion: a systematic review

PURPOSE: Patients undergoing spinal fusion are prone to develop persisting spinal pain that may be related to pre-existent psychological factors. The aim of this review was to summarize the existing evidence about perioperative psychological interventions and to analyze their effect on postoperative pain, disability, and quality of life in adult patients undergoing complex surgery for spinal disorders. Studies investigating any kind of psychological intervention explicitly targeting patients undergoing a surgical fusion on the spine were included. METHODS: We included articles that analyzed the effects of perioperative psychological interventions on either pain, disability, and/or quality of life in adult patients with a primary diagnosis of degenerative or neoplastic spinal disease, undergoing surgical fusion of the spine. We focused on interventions that had a clearly defined psychological component. Two independent reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) to perform a systematic review on different databases. Risk of bias was evaluated using the Downs and Black checklist. Given study differences in outcome measures and interventions administered, a meta-analysis was not performed. Instead, a qualitative synthesis of main results of included papers was obtained. RESULTS: Thirteen studies, conducted between 2004 and 2017, were included. The majority were randomized-controlled trials (85%) and most patients underwent lumbar fusion (92%). Cognitive behavioral therapy (CBT) was used in nine studies (69%). CBT in the perioperative period may lead to a postoperative reduction in pain and disability in the short-term follow-up compared to care as usual. There was less evidence for an additional effect of CBT at intermediate and long-term follow-up. CONCLUSION: The existing evidence suggests that a reduction in pain and disability in the short-term, starting from immediately after surgery to 3 months, is likely to be obtained when a CBT approach is used. However, there is inconclusive evidence regarding the long-term effect of a perioperative psychological intervention after spinal fusion surgery. Further research is necessary to better define the frequency, intensity, and timing of such an approach in relation to the surgical intervention, to be able to maximize its effect and be beneficial to patients

Vertebral body stent augmentation to reconstruct the anterior column in neoplastic extreme osteolysis.

BACKGROUND Extensive lytic lesions of the vertebral body (VB) increase risk of fracture and instability and require stabilization of the anterior column. Vertebral augmentation is an accepted treatment option, but when osteolysis has extensively destroyed the VB cortical boundaries (a condition herein defined as 'extreme osteolysis'), the risk of cement leakage and/or insufficient filling is high. Vertebral body stents (VBSs) might allow partial restoration of VB height, cement containment, and reinforcement, but their use in extreme osteolysis has not been investigated. OBJECTIVE To assess retrospectively the feasibility and safety of VBS augmentation in patients with 'extreme osteolysis' of the VB. METHODS We retrospectively analyzed 41 treated vertebrae (from T1 to L5). VB reconstruction was assessed on postprocedure CT images and rated on a qualitative 4-point scale (poor-fair-good-excellent). Clinical and radiological follow-up was performed at 1 month and thereafter at intervals in accordance with oncological protocols. RESULTS VBS augmentation was performed at 12 lumbar and 29 thoracic levels, with bilateral VBS in 23/41. VB reconstruction was judged satisfactory (good or excellent) in 37/41 (90%) of levels. Bilateral VBS received higher scores than unilateral (p=0.057, Pearson's X). We observed no periprocedural complications. Cement leaks (epidural or foraminal) occurred at 5/41 levels (12.2%) without clinical consequences. Follow-up data were available for 27/29 patients, extending beyond 6 months for 20 patients (7-28 months, mean 15.3 months). VBS implant stability was observed in 40/41 cases (97.5%). CONCLUSIONS Our results support the use of VBS as a minimally invasive, safe and effective option for reconstructing the anterior column in prominent VB osteolysis

Stent screw–assisted internal fixation (SAIF): clinical report of a novel approach to stabilizing and internally fixating vertebrae destroyed by malignancy

OBJECTIVESevere lytic cancerous lesions of the spine are associated with significant morbidity and treatment challenges. Stabilization and restoration of the axial load capability of the vertebral body (VB) are important to prevent or arrest vertebral collapse. Percutaneous stent screw–assisted internal fixation (SAIF), which anchors a VB stent/cement complex with pedicular screws to the posterior vertebral elements, is a minimally invasive, image-guided, 360° internal fixation technique that can be utilized in this patient cohort. The purpose of this study was to assess the feasibility, safety, and stabilization efficacy of VB reconstruction via the SAIF technique in a cohort of patients with extensive lytic vertebral lesions, who were considered to have an unstable or potentially unstable spine according to the Spinal Instability Neoplastic Score (SINS).METHODSThis study was a retrospective assessment of a prospectively maintained database of a consecutive series of patients with neoplastic extensive extracompartmental osteolysis (Tomita type 4–6) of the VB treated with the SAIF technique. VB reconstruction was assessed on postprocedure plain radiographs and CT by two independent raters. Technical and clinical complications were recorded. Clinical and imaging follow-ups were assessed.RESULTSThirty-five patients with extensive osteolytic metastatic lesions of the VB underwent 36 SAIF procedures. SAIF was performed as a stand-alone procedure in 31/36 cases and was associated with posterior surgical fixation in 5/36 (4/5 with decompressive laminectomy). In 1 case an epidural cement leak required surgical decompression. VB reconstruction was categorized as satisfactory (excellent or good rating) by the two raters in 34/36 cases (94.5%) with an interrater reliability of 94.4% (Cohen's kappa of 0.8). Follow-up, ranging from 1 to 30 months, was available for 30/36 levels. Long-term follow-up (6–30 months, mean 11.5 months) was available for 16/36 levels. Stability during follow-up was noted in 29/30 cases.CONCLUSIONSSAIF provides 360° nonfusion internal fixation that stabilizes the VB in patients with extensive lytic lesions that would otherwise be challenging to treat

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial

INTRODUCTION: Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS: This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER: NCT02763956. PROTOCOL VERSION: 7.1, 18 November 2020