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.

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.

[Percutaneous vertebroplasty for malignant and non-malignant vertebral spinal fractures].

This is a review of percutaneous vertebroplasty (PVP), which has been performed since the 1980s. Initially, PVP was for palliative treatment of malignant lesions in columna, and later it was for osteoporotic fractures. According to hundreds of studies, PVP has had great pain reductive effect com-pared to conservative treatment i.e. analgesics. Traditionally, the procedure has been offered to patients with persistent pain despite a period of conservative treatment. New re-search suggests, that PVP has the best effect if completed within six weeks of pain debut.

Danish national clinical guidelines for surgical and nonsurgical treatment of patients with lumbar spinal stenosis.

PURPOSE: To summarize the recommendations from the national clinical guideline published by the Danish Health Authority regarding surgical and nonsurgical interventions in treatment of lumbar spinal stenosis in patients above the age of 65 years. METHODS: A multidisciplinary working group formulated recommendations based on the GRADE approach. RESULTS: Seven of the recommendations were based on randomized controlled trials and three on professional consensus. The guideline recommends surgical decompression for symptomatic lumbar spinal stenosis. Supervised exercise and postsurgical supervised exercise are recommended due to the general beneficial effects of training on general health, even though there was no evidence on an effect on neurogenic pain. The guideline does not recommend manual therapy, paracetamol, NSAIDs, opioids, neurogenic pain medication, muscle relaxants, and decompression combined with instrumented fusion as there was no evidence of the beneficial effect. CONCLUSION: The recommendations are based on low to very low quality of evidence or professional consensus as well as patient preferences and positive or harmful effects of the intervention. The true treatment effect may therefore be different from the estimated effects, which is why the results should be interpreted with caution. The working group recommends intensified research in relation to all aspects of management of lumbar spinal stenosis. These slides can be retrieved under Electronic Supplementary Material.

Vertebroplasty or kyphoplasty as palliative treatment for cancer-related vertebral compression fractures: a systematic review.

BACKGROUND CONTEXT: Percutaneous vertebroplasty (PVP) and kyphoplasty (KP) are minimally invasive treatment options for vertebral compression fractures (VCFs) due to malignancy. PURPOSE: To perform a systematic review evaluating the effectiveness and safety of vertebral augmentation for malignant VCFs. STUDY DESIGN: Systematic review. STUDY SAMPLE: Studies on PVP or KP for VCFs in patients with malignant spinal lesions. OUTCOME MEASURES: Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), Karnofsky Performance Score (KPS), and complications were extracted from eligible studies. METHODS: Using Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, studies published between January 1, 2000 and January 3, 2018 were identified by combining the results of a report by Health Quality Ontario with an updated literature search. RESULTS: The review identified two randomized controlled trials, 16 prospective studies, 44 retrospective studies, and 25 case series for a patient sample size of 3,426. At the earliest follow-up, pain improved from 7.48 to 3.00 with PVP, and from 7.05 to 2.96 with KP. ODI improved from 74.68 to 17.73 with PVP, and from 66.02 to 34.73 with KP. KPS improved from 66.99 to 80.28. Cement leakage was seen in 37.9% and 13.6% of patients treated with PVP and KP, respectively. Symptomatic complications (N = 43) were rare. CONCLUSIONS: This review showed clinically relevant improvements in pain, ODI, and KPS in patients with VCFs due to malignancy treated with either PVP or KP. Cement leakage is common, but rarely symptomatic. Percutaneous vertebroplasty and KP are safe and effective palliative procedures for painful VCFs in patients with malignant spinal lesions.

Usefulness of the STarT Back Screening Tool to predict pain problems after lumbar spine surgery.

INTRODUCTION: The Subgroups for Targeted Treatment (STarT) Back Screening Tool is used in general practice to stratify patients with acute back pain into either a low, medium or a high risk of developing complex pain. This study determines if the STarT Back Screening Tool can identify patients who are at a high risk of developing complex pain after spine surgery. METHODS: The STarT Back Screening Tool was administered pre-operatively to a consecutive series of patients who had lumbar spine surgery between 29 October 2012 and 1 February 2013. A visual analogue scale (VAS, 0-100) for back and leg pain was determined pre-operatively and also on the first day after surgery, at discharge, at 4 to 12 weeks after surgery, and one year after surgery. Patients were stratified into those who underwent decompression only for lumbar disc herniation or stenosis and those who underwent decompression and fusion for spondylolisthesis. RESULTS: In the decompression group, high-risk patients had poorer pre-operative back and leg pain scores, but similar length of stay, improvements in back or leg pain at 4-12 week and at the one-year follow-up compared with the other groups. The high-risk group experienced a significantly greater improvement in leg pain on the first post-operative day and on the day of discharge. In the decompression and fusion group, high-risk patients had poorer pre-operative back and leg pain scores than the other groups. There were no significant differences in back or leg pain improvement among the three groups at any time point during follow-up. CONCLUSIONS: The results of this study show that the STarT Back Screening Tool may be useful for identifying patients who are at a high risk of developing complex pain after spine surgery. FUNDING: none. TRIAL REGISTRATION: not relevant.

Percutaneous vertebroplasty is safe and effective for cancer-related vertebral compression fractures.

INTRODUCTION: In cancer patients with painful vertebral fractures due to spinal metastasis, traditional pain-relieving therapies include analgesics, bed rest, steroids, radio-ther-apy, etc. These treatment modalities are often ineffective. Traditional spinal surgery in general anaesthesia is usually not an option in patients with advanced cancer and in a poor general condition. Percutaneous vertebroplasty (PVP) has been reported as a minimally invasive treatment option with apparent rapid pain relief compared with other conventional treatment options. The objective of this study was to assess the safety and efficacy of PVP in patients with malignant spinal lesions. METHODS: From the National Danish Surgical Spine Database, DaneSpine, 30 consecutive cancer patients with vertebral fractures who underwent PVP from 2013 to 2017 were identified. From DaneSpine, the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) and the Oswestry Disability Index (ODI) scores were collected pre- and post-operatively. Data on the incidence of complications and poly-methyl methacrylate leaks were obtained by review of medical records and plain post-operative X-rays. RESULTS: The mean improvement in EQ-5D scores from baseline was 0.30 (p < 0.01) after three months, and 0.25 (p = 0.01) after one year. The ODI improved from 44.1 to 23.3 (p < 0.01). Despite a cement leakage rate of 14.8%, no patients presented with any clinically significant symptoms. CONCLUSIONS: PVP is a safe procedure providing a statistically significant and clinically relevant improvement in quality of life and function of patients with cancer-related vertebral compression fractures. Our findings may provide useful information to healthcare professionals who are treating cancer. FUNDING: none. TRIAL REGISTRATION: not relevant.

No differences in post-operative rehabilitation across municipalities in patients with lumbar disc herniation.

INTRODUCTION: Following the municipal reform in Denmark in January 2007, the municipalities gained responsibility for post-operative rehabilitation. In the Region of Southern Denmark, this task was decentralised to 22 municipalities, which implied a possible risk for considerable variation. This study examined rehabilitation in the 22 municipalities of the Region of Southern Denmark for patients with lumbar disk herniation. METHODS: A total of 22 physiotherapists answered a questionnaire regarding their rehabilitation programmes. The municipalities of 789 patients who had undergone decompressive surgery for lumbar disc herniation were identified. Changes in Oswestry disability index (ODI), EuroQol-5D (EQ-5D) and duration of sick leave were compared among the municipalities. RESULTS: Patient-reported outcome measures showed no statistical difference in ODI, EQ-5D or sick leave at the one-year follow-up across the 22 municipalities. There was a correlation between sick leave and outcome as a longer sick leave was associated with less improvement in EQ-5D and ODI. Rehabilitation programmes across the region were comparable with respect to several factors. The questionnaire revealed a potential for enhanced cooperation between hospitals and rehabilitation centres. CONCLUSION: Rehabilitation was broadly similar, and patient outcome after one year did not differ significantly across the 22 municipalities or between the five largest samples. In general, all municipalities request enhanced cooperation between hospital and rehabilitation unit to ensure the best possible patient treatment. Further studies should focus on the effect of rehabilitation. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study.

STUDY DESIGN: Clinical randomized study. OBJECTIVE: Percutaneous vertebroplasty is compared to conservative treatment in patients with acute or subacute osteoporotic vertebral fractures with respect to pain, physical and mental outcomes. The risk of vertebral fractures adjacent to treated levels is assessed. SUMMARY OF BACKGROUND DATA: There are some disagreements of the benefits of PVP for the treatment of acute osteoporotic vertebral fractures, but the long-term clinical outcome of PVP compared to conservative treatment has not been evaluated in a randomized study. METHODS: The 3-months follow-up of this study has been published previously, and here we report the completed 12-months analysis. About 50 patients (41 females) were included from January 2001 until January 2008. Patients with vertebral fractures less than 8 weeks old were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale. Physical and mental outcomes were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 and 12 months. RESULTS: Pain score before and after the operation in the PVP group was 7.9 and 2.0, respectively. There was no difference between the groups concerning pain at the 3- and 12-months follow-up. Supplementary assessment of back pain 1 month after discharge from hospital showed a significant lower VAS score in the PVP group over the conservative group. In the study period, 2 adjacent fractures in the PVP group and no adjacent fractures in the conservative group were registered. CONCLUSION: PVP is a good treatment for some patients with acute/subacute painful osteoporotic vertebral fractures, but the majority of fractures will heal after 8 to 12 weeks of conservative treatment with subsequent decline in pain. The risk of new fractures needs further research.

[Percutaneous vertebroplasty with only few complications--a retrospective study]. / Perkutan vertebroplastik med kun få komplikationer--et retrospektivt studie.

INTRODUCTION: Percutaneous vertebroplasty (PVP) was introduced in 1984 and has proved to be valuable in the treatment of painful vertebral lesions such as haemangiomas, metastasis, and osteoporotic fractures. According to the literature, the operation provides pain relief with only few and harmless complications. The aim of this study was to evaluate our perioperative experiences with special reference to the safety of the procedure. MATERIAL AND METHODS: A total of 156 procedures were performed in 148 patients with osteoporotic fractures. Both acute and chronic fractures were treated. All patients had plain radiographs of the spine. Magnetic resonance imaging (MRI) or bone scans were performed in case of old fractures or more than one fracture in patients with acute back-pain. At follow-up after three and 12 months, plain radiographs were performed in conjunction with physical examinations and interviews. Data were collected retrospectively. RESULTS: We identified 40.4% cemental leaks (confidence interval (CI) 32.6; 48.5). None of these resulted in neurological symptoms. One patient experienced shortness of breath after the procedure, one had atrial fibrillation, and one patient had an iatrogenic pneumothorax. In all, the frequency of symptomatic complications was 1.9% (CI -0.4; 5.5). CONCLUSION: We believe that PVP is a safe procedure with only few symptomatic complications when performed under local anaesthesia and by a specialist in transpedicular approach.

Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study.

STUDY DESIGN: Clinical randomized study. OBJECTIVE: The aim of this study is to compare percutaneous vertebroplasty (PVP) to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomized study with respect to pain, physical and mental outcome, and to asses the risk of adjacent fractures. SUMMARY OF BACKGROUND DATA: PVP is a therapeutic procedure performed to reduce pain in vertebral lesions. Despite the lack of comparative randomized clinical trials PVP is generally seen as a safe and efficient procedure for painful osteoporotic fractures. METHODS: Fifty patients (41 females) were included from January 2001 until January 2008. Patients with acute (<2 weeks) and subacute (between 2 and 8 weeks) osteoporotic fractures were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale and physical and mental outcome were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 months. RESULTS: Reduction in pain from initial visit to 3-month follow-up was comparable in the 2 groups (P = 0.33) from approximate visual analogue scale 8.0 to visual analogue scale 2.0, intragroup difference was significant (P = 0.00). Reduction in pain in the PVP group was immediate 12 to 24 hours after the procedure (P = 0.00). There was no significant difference in the other parameters when comparing the results at inclusion and after 3 months within both groups and between the groups after 3 months with a few exceptions. We observed 2 adjacent fractures in the PVP group and non in the conservative group. CONCLUSION: The majority of patients with acute or subacute painful osteoporotic compression fractures in the spine will recover after a few months of conservative treatment. The risk of adjacent fractures needs further research. No major adverse events were observed.