How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/follow up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Anchala PR, Irving WD, Hillen TJ et al (2014). Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: A multicenter retrospective study. Pain Physician; 17:317-327.

    Retrospective study

    N=92 patients with 128 spinal metastatic osseous lesions

    radiofrequency ablation (RFA) STAR tumour ablation system used (96 procedures were done). Cement augmentation was done when needed.

    Follow up 6 months

    RFA was successful in all. Significant (p< 0.01) decreases in the VAS scores noted at follow up. 54% patients experienced a decrease and 30% had no change in their pain medications.

    Study included in systematic review added to table 2.

    Angileri, SA, Granata G, Savoldi, AP et al. (2020) Cooled radiofrequency ablation technology for painful bone tumors

    Acta bio-medica : Atenei Parmensis; 91 (10s); e2020007

    Case report

    Osteocool RF Ablation System (Medtronic) on a patient with a painful bone metastasis localized in the 5th lumbar vertebra showed encouraging results. The radiofrequency ablation of bone metastases with palliative aim represents an excellent treatment option, as it is a minimally invasive and safe procedure, and can be repeated multiple times.

    Case report

    Bagla S, Sayed D, Smirniotopoulos J et al (2016). Multicenter prospective clinical series evaluating radiofrequency ablation in the treatment of painful spine metastases. Cardiovasc Intervent Radiol; 39:1289-1297.

    Prospective study

    N=50 patients with vertebral body metastases.

    Radiofrequency ablation (RFA) STAR tumour ablation system used (69 treatments).

    Cement augmentation was done in 96%.

    Follow up 3 months

    Significant improvement in scores for pain, disability, and cancer-specific health-related quality of life from baseline was seen. NRPS improved from 5.9 to 2.1 (p<0.0001). ODI improved from 52.9 to 37.0 (p<0.08). FACT-G7 improved from 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p<0.001). No complications related to the procedure were reported.

    Study included in systematic review added to table 2.

    Cazzato RL, GarnonJ, CaudrelierJ,Prabhakar RaoP,Koch G, Gangi, A.Low-power bipolar radiofrequency ablation and vertebral augmentation for the palliative treatment of spinal malignancies. Int. J. Hyperthermia. 2018, VOL. 34, NO. 8, 1282–1288. https://pubmed.ncbi.nlm.nih.gov/29347855/

    N=11 patients with painful spinal tumours treated with bipolar RFA and vertebral augmentation. 

    Low-power bipolar RFA performed with internally cooled electrodes and coupled to vertebral augmentation provides safe and effective early analgesia in patients affected by painful spinal malignancies.

    Larger studies added to the overview.

    David E, Kaduri S, Yee A, et al. Initial single center experience: radiofrequency ablation assisted vertebroplasty and osteoplasty using a bipolar device in the palliation of bone metastases. Ann Palliat Med. 2017;6(2):118-124. doi:10.21037/apm.2016.12.02.

    Retrospective study

    N=26 patients.

    bipolar-RFAsystem with standard (70 ◦C)targettemperature and vertebroplasty in 35 vertebral levels.

    RFA assisted VP and OP using a bipolar device is safe and allows for controlled injection of cement into a preformed thermal cavity with a significant decrease in venous and posterior cement leaks. Rate of cement leakage into the disc spaces was unaffected

    Larger studies included in the overview summary.

    Dupuy De, Hong R, Oliver B et al (2000). Radiofrequency ablation of spinal tumors: temperature distribution in the spinal canal. Technical Innovation. AJR:175, 1263-66.

    Review

    This innovative new approach provides not only pain palliation but also local tumour control, thus avoiding additional therapy such as radiation or surgery.

    Review

    Dabravolski D, Lahm A, Eser J, Merk H (2015). Tumours and metastases of the spine: Cavity/coblation surgery and vertebroplasty/kyphoplasty. Orthopade; 44:806-819.

    Retrospective study

    N=250 patients with spinal tumours or metastases

    Radiofrequency ablation done with CAVITY SpineWand followed by kyphoplasty.

    Follow up 60 months

    Significant pain reduction, satisfaction, early mobilization, and improvement in quality of life were demonstrated in all patients. Lower complication rates reported.

    Study included in systematic review added to table 2.

    Filippiadis D, Kelekis A (2021) Percutaneous bipolar radiofrequency ablation for spine metastatic lesions.

    European Journal of Orthopaedic Surgery and Traumatology https://doi.org/10.1007/s00590-021-02947-9

    Review on

    imaging guided percutaneous bipolar radiofrequency ablation.

    Percutaneous radiofrequency ablation of vertebral lesions is a reproducible, successful and safe procedure. Ablation should be combined with vertebral augmentation in all cases. In order to optimize maximum efficacy a patient and a lesion-tailored approach should both be offered focusing upon clinical and performance status along with life expectancy of the patient as well as upon lesion characteristics.

    Review

    Gazis AN, Beuing O, Franke J et al (2014). Bipolar radiofrequency ablation of spinal tumors: Predictability, safety, and outcome. Spine J; 14:604-608.

    Prospective study

    N=36 patients with advanced spine tumour (39 lesions) had radiofrequency ablation.

    CelonLab Power and Celon Aquaflow III

    Follow up not reported.

    The extent of the ablation zones was predictable to the millimetre because it did not cross planned dorsal and ventral boundaries. No complications were observed.

    Study included in systematic review added to table 2.

    Gazis A, Beuing O, Jollenbeck B et al (2012). Bipolar radiofrequency ablation of spinal neoplasms in late stage cancer disease. A report of three cases. SPINE 37, 1, pp E64–E68.

    Case series

    N=3 patients with metastases of the spine had bipolar radiofrequency ablation.

    Ablation of tumours adjacent to neural structures is feasible. Spinal cord damage can be avoided by planning.

    Larger studies with longer follow up included in table 2.

    Georgy BA, Wong W. Plasma-mediated radiofrequency ablation assisted percutaneous cement injection for treating advanced malignant vertebral compression fractures. AJNR Am J Neuroradiology 2007; 28:700-705.

    Prospective series

    N=15 patients with metastatic lesions epidural extension and/or cortical disruption had radiofrequency ablation and cement augmentation.

    Extraosseous extension of cement was observed in 4 cases but was clinically inconsequential. No thermal or neuronal insult was observed. 87% (13/15) of patients reported decreased pain.

    Larger studies with longer follow up included in table 2.

    Georgy BA. Bone cement deposition patterns with plasma-mediated radiofrequency ablation and cement augmentation for advanced metastatic spine lesions. AJNR Am J Neuroradiology 2009; 30:1197-1202.

    Retrospective study

    N=37 patients with advanced metastatic lesions (at 44 levels) had plasma mediated RFA and cement augmentation.

    Cavity SpineWand was used.

    Follow up 2-4 weeks

    Procedure allowed greater cement-deposition control, successfully stabilising the anterior two thirds of the vertebral body. This combined technique was useful in cases with posteriorly located lesions. The incidence of cement extravasation was high but clinically insignificant.

    Study included in systematic review added to table 2.

    Gronemeyer DH, Schirp S, Gevargez A. (2002). Image-guided radiofrequency ablation of spinal tumors: preliminary experience with an expandable array electrode. Cancer J 8:33–9.

    Case series

    N=10 (21 vertebral lesions) spine metastases were treated with radiofrequency ablation. Vertebroplasty done in 4 cases.

    Follow up average 5.8 months.

    90% of patients reported pain relief, disability reduced by 27%, neurological function preserved in 9, general health stabilised in 6 and improved in 3.

    Study included in systematic review added to table 2.

    Greenwood TJ, Wallace A, Friedman MV et al (2005). Combined ablation and radiation therapy of spinal metastases: a novel multimodality treatment approach. Pain Physician; 18:573-581

    Retrospective study

    N= 21 patients with 36 spine metastases were treated with radiotherapy and either RFA or cryoablation.

    Mean worst pain score (8.0) significantly decreased at both one week (4.3, p<.02) and 4 weeks (2.9, p<.0003). Radicular pain occurred in 1 patient. Post-procedural imaging at 6 months showed stable disease in 12/13 treatments at 3 months and 10/10 at 6 months.

    Combined treatment (RFA plus radiotherapy)

    Halpin RJ, Bendok BR, Sato K et al (2005). Combination treatment of vertebral metastases using image-guided percutaneous radiofrequency ablation and vertebroplasty: a case report. Surgical neurology. 63 (5), 469-474.

    Case report

    n-1 case of vertebral metastases treated with a combination of percutaneous radiofrequency ablation (RFA) and vertebroplasty.

    No complications. pain relief was immediate.

    Larger studies with longer follow up included in table 2.

    Hillen, Jennings et al., Radiology 2015

    Hillen TJ,  Anchala P,  Friedman MV et al. (2014) Treatment of metastatic posterior vertebral body osseous tumors by using a targeted bipolar radiofrequency ablation device: technical note. Radiology;273(1):261-7.

    Retrospective study

    N= 26 patients (47 tumours) with painful metastatic posterior vertebral body tumours some radiation therapy resistant had RFA

    Follow up 1 month.

    Targeted RFA with a newly developed articulating device is both feasible and safe for the treatment of painful posterior vertebral body metastatic tumours

    Larger studies with longer follow-up included in table 2.

    Holbert JA, Nguyen DA (2018). Percutaneous Radiofrequency Ablation for painful spinal metastases resulting in resolution of epidural disease: a case report. Cureus 10(5): e2579.

    Case report

    N=1 case of metastatic prostate cancer with epidural extension treated with percutaneous image-guided radiofrequency ablation and vertebral augmentation

    This case showed that epidural disease can be treated with radiofrequency ablation and vertebral augmentation.

    Larger studies with longer follow up included in table 2.

    Kai G, Chuan L and Fang L (2015). Minimally invasive treatments of spinal metastases: Vertebroplasty, radiofrequency ablation and radiation therapy. Chinese Journal of Tissue Engineering Research. DOI: 10.3969/j.issn.2095-4344.2015.16.029

    Review of 3 kinds of minimally invasive treatments for spinal metastases.

    Vertebral cement augmentation efficiency is 80-90%. Radiofrequency ablation and radiation can kill the tumour but cannot rebuild the vertebral stability. Therefore, the combination of different technologies can improve the therapeutic effect on spinal tumours. Above all, there is not a perfect minimally invasive treatment for spinal metastases

    Review

    Kam NM, Maingard JM, Kok HK et al (2017). Combined vertebral augmentation and radiofrequency ablation in the management of spinal metastases: an update. Curr. Treat. Options in Oncol. 18: 74.

    Radiofrequency ablation have shown success in reducing pain and improving function in patients with symptomatic spinal metastases. Both vertebral augmentation and RFA are recognised as excellent alternative in patients with spinal metastases.

    Opinion statement.

    Kastler A, Barbe D-A; Alemann G et al. (2021) Bipolar Radiofrequency Ablation of Painful Spinal Bone Metastases Performed under Local Anesthesia: Feasibility Regarding Patient's Experience and Pain Outcome. Medicina (Kaunas, Lithuania); 57 (9)

    N=25 patients with refractory painful vertebral metastases had 29 bipolar RFA procedures (16 combined with vertebroplasty) under local anaesthesia.

    Procedure tolerance was graded as either not painful or tolerable in 97% of cases. Follow up post-procedure mean VAS score decrease was 74% at day 1: 6.6 (p < 0.001), 79% at 1 month: 6.6 (p < 0.001), 79% at 3 months: 6.5 (p < 0.001), 77% at 6 months, and 79% at 12 months: 6.6 (p < 0.001).

    Results not reported separately for RFA alone and RFA combined with vertebroplasty.

    Kotecha R, Schiro BJ, Sporrer J et al. (2020) Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials; 21 (1); 964

    NCT04375891

    RCT protocol

    Patients with spine metastasis from T5-L5, randomized in a 2:1 ratio to either radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) and EBRT or EBRT alone.

    Primary objective is whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives are whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL.

    Combined treatment (radiotherapy plus RFA/PVA versus radiotherapy)

    Protocol only

    Krajnovic, B.; Sadat, S.; Cirovic, D.; Radiofrequency ablation and vertebral kyphoplasty for palliation of painful spinal metastatic lesions. European Spine Journal; 2019; vol. 28; 2726

    Retrospective review

    N=60 patients (75 painful spinal metastases: 46 in the lumbar spine and 29 in the thoracic region) treated with combined RFA and PKP for painful neoplastic bone lesions using OsteoCoolTM RF Ablation System.

    Follow up: postoperative

    The mean pre-procedure and post-procedure VAS was 7.2/10 and 2.7/10 respectively. Patients reported clinically significant decreased pain (p value of 0.0001). No neurological complication occurred related to RFA and no cement extravasation into spinal canal was observed. In 2 patients an asymptomatic leak into the needle track, in 2 patients into draining veins and in one patient into the disc space was detected.

    Studies with longer follow up included in the summary of evidence.

    Kurth A, Muller-Broich JD (2019) STAR RF-ablation for the management of painful vertebral bone metastases. Osteologie; 28 (1); 46

    Retrospective case series

    N=52 patients with painful vertebral bone metastases (from a wide variety of metastatic lesions).

    RFA followed by vertebral augmentation.

    Follow up 6 months

    RFA procedures were successfully performed in all. All patients reported pain relief. Average VAS improved from 7.8 pre to 4.4 one week post RFA (p < 0.05). and 3.0 after 6 months of the procedure (p < 0.05). No device related adverse events were reported.

    Larger studies included in summary of evidence.

    Li M, Zhang N and Zhang X et al (2020). Effects of surgery and radiofrequency ablation in the treatment of spinal metastases and analysis of the influencing factors of prognosis. Experimental and Therapeutic Medicine 19: 1072-1078.

    Retrospective comparative study

    N= 132 patients with spinal metastases

    (65 had surgery alone and 65 had RFA assisted surgery).

    Follow up 36 months

    Operation time and blood loss, rate of complications and 3-year recurrence rate in the RFA assisted surgery group was significantly lower than in surgery alone group (p<0.05). The VAS and KPS scores significantly improved in RFA surgery group compared with those in the control group (p<0.05). The 3-year survival rate was significantly higher than that in the surgery group (p<0.05).

    Combined treatment

    Surgery plus RFA

    Madaelil TP, Wallace AN, Jennings JW (2016). Radiofrequency ablation alone or in combination with cementoplasty for local control and pain palliation of sacral metastases: preliminary results in 11 patients. Skeletal Radiol; 45:1213-1219.

    Retrospective study

    N=11 RFA procedures done to treat 16 sacral metastases. Cementoplasty was done in 63% (7/11) cases.

    Follow up 4.7 months.

    The median pain score decreased from 8 at baseline to 3 at 1 month following RFA (p= 0.004). No acute or long-term complications were noted.

    Study included in systematic review added to table 2.

    Masala S, Roselli M, Massari M et al (2004). Radiofrequency heat ablation and vertebroplasty in the treatment of neoplastic vertebral body fractures. Anticancer Research 24: 3129-3134

    Case series

    N=3 patients with metastatic vertebral collapse.

    Procedure success 100%. swift pain relief and reduction in symptoms, associated with an evident augmentation in the weight-bearing resistance.

    Larger studies with longer follow up included in table 2.

    Mayer T, Cazzato RL, Marini P De et al (2020). Spinal metastases treated with bipolar radiofrequency ablation with increased (> 70 ◦C) target temperature: Pain management and local tumor control. Diagnostic and Interventional Imaging 102, 27–34

    Retrospective study

    N=31 patients with 37 metastases who were treated with b-RFA with mean temperature 88 C and vertebroplasty.

    Technical success was 100% (37/37). One major complication unrelated to b-RFA was reported. Pain management in 80% (16/20) at a mean follow up of 3.4 months or 100% (6/6) with

    oligometastatic/oligo-progressive disease at a mean follow up of 5 months. In patients receiving b-RFA to prevent complications, 60% (6/10) had favourable outcome at a mean follow up of 3 months.

    Larger studies included in table 2.

    Mehta TI, Heiberger C, Kazi S, et al (2020). Effectiveness of Radiofrequency Ablation in the Treatment of Painful Osseous Metastases: A Correlation Meta-Analysis with Machine Learning Cluster Identification. J Vasc Interv Radiol; 31:1753-62.

    Systematic review and meta-analysis

    N=14 studies (426 patients with recalcitrant pain).

    Median pain reduction after RF ablation was 67% over median follow up of 24 weeks (R2 ¼.66, 95% confidence interval -0.76 to -0.55, I2 = 71.24%, fail-safe N = 875) with 44% pain reduction within 1 week. A low-heterogeneity subgroup was identified with median pain reduction after RF ablation of 70% over 12 weeks (R2 = -.75, 95% confidence interval -0.80 to -0.70, I2 = 2.66%, fail-safe N = 910). Addition of cementoplasty after RF ablation did not significantly affect pain scores. Primary tumour type and tumour size did not significantly affect pain scores. A particular, positive association between pain after RF ablation and axial tumours was identified, implying possible increased palliative effects for RF ablation on axial over appendicular lesions.

    RFA for osseous metastases (not just spinal metastasis… only 4 studies related to spinal metastasis were included).

    Mehta T, Heiberger C, Kazi S et al. (2020) Radiofrequency ablation versus stereotactic body radiotherapy for painful osseous metastases: A comparative correlation metaanalysis of pain relief. Journal of Clinical Oncology; 38 (15)

    Systematic review

    Patients with painful osseous-metastases.

    SBRT (n=1100) versus RFA (n=557).

    Median follow up was 24 weeks for SBRT and 18 weeks for RFA

    No studies directly compared SBRT to RFA. Median pain reduction of 59% (SBRT

    R =0.83, 95%CI:0.80-0.87, I =58.63%) and 64% (RFA

    R =0.52, 95%CI:0.41-0.62, I =48.16%) was reported respectively. Pain reduction and durability post-SBRT or post-RFA are comparable.

    RFA for osseous metastases (not just spinal metastasis… only 4 studies related to spinal metastasis were included).

    Nakatsuka A, Yamakado K, Takaki H et al (2009). Percutaneous radiofrequency ablation of painful spinal tumors adjacent to the spinal cord with real-time monitoring of spinal canal temperature: A prospective study. Cardiovasc Intervent Radiol; 32:70-75.

    Prospective study

    N=10 patients with spinal tumours treated with cool-tip RF ablation system.

    Follow up 4.5 months

    Procedure success was 100%. Clinical success was achieved within 1 week in all patients (100).

    Study included in systematic review added to table 2.

    Neufeld N, Davis J, Elshihabi S. (2021) Radiofrequency Ablation and Vertebroplasty of Cervical Metastatic Lesion: A Novel Anterior Approach

     Neuromodulation; 24 (4); e219-e220

    Case report

    N=1 patient with lymphoma and an anterior C7 metastatic lesion

    RFA and cement vertebroplasty through an anterior approach.

    pain was completely resolved and rated as 0/10. complete resolution of the lesion was seen on CT scan.

    Larger studies included in evidence summary.

    Proschek D, Kurth A, Proschek P, et al. (2009). Prospective pilot study of combined bipolar radiofrequency ablation and application of bone cement in bone metastases. Anticancer Res 29:2787–92.

    Prospective study

    N=16 patients with painful spinal bone metastases treated with RFA alone (n=8) or RFA with bone cement (n=8).

    Celon prosurge & celon power RFA system was used

    Follow up 20.4 months

    In both groups (RFA alone and RFA with bone cement), pain was reduced significantly (mean reduction of pain 51.7%, p=0.0065). Quality of life was improved up to 61%. No side-effects and complications. Complete ablation of the bone tumour in all. No local tumour progression was seen.

    Study included in systematic review added to table 2.

    Pusceddu C, De Francesco D, Melis L et al. (2021) The Role of a navigational Radiofrequency Ablation Device and Concurrent Vertebral Augmentation for Treatment of Difficult-to-Reach Spinal Metastases.

    Current oncology. 28 (5); 4004-4015

    Case series

    N=35 patients with 41 vertebral spinal metastases had CT guided percutaneous targeted RFA, associated with vertebral augmentation.

    Median follow up of 19 months (4-46 months).

    mean VAS score dropped from 5.7 (95% CI 4.9-6.5) before targeted RFAand to 0.9 (95% CI 0.4-1.3) after RFA (p < 0.001). The mean decrease in VAS score between baseline and 1 week follow up was 4.8 (95% CI 4.2-5.4). VAS decrease over time between 1 week and 1 year was similar. No patients showed signs of local progression or recurrence.

    Similar studies included in the summary of evidence.

    Nakatsuka A, Yamakado K, Maeda M, et al. Radiofrequency ablation combined with bone cement injection for the treatment of bone malignancies. J Vasc Interv Radiol 2004; 15 : 707 – 12.

    Case series

    N=17 (23 bone tumours: spine (n = 17), iliac bone (n = 3), sacrum (n = 2), and ischial bone (n = 1).

    RFA followed by cement augmentation.

    Combined therapy feasible. Technical success 96%. Pain relief within 1 week 100%, significant decrease in the VAS score from 8.4 to 1.1 (P <.001). Neural damage occurred in 4 patients in whom the tumour had invaded the posterior cortex of the vertebral body and pedicle.

    Included in systematic review added to overview.

    Ragheb A, Vanood A, Fahim DK (2022) The Addition of Radiofrequency Tumor Ablation to Kyphoplasty May Reduce the Rate of Local Recurrence in Spinal Metastases Secondary to Breast Cancer. World neurosurgery; 161; e500-e507.

    Retrospective medical chart analysis

    N=23 breast cancer patients with metastatic spinal fractures (n = 50 vertebral levels) who underwent RFA and kyphoplasty

    6 months follow up.

    Significant reductions in pain levels were observed postoperatively, at discharge (3.5; P < 0.05), at 1-month follow up (2.8; P < 0.05), at 3-month follow up (1.1; P < 0.05), and at 6-month follow up (0.7 P < 0.05),

    Larger studies included in summary of evidence.

    Sandri A, Carbognin G, Regis D et al (2010). Combined radiofrequency and kyphoplasty in painful osteolytic metastases to vertebral bodies. Radiol med; 115:261–271

    Case series

    N=11 patients with painful osteolytic vertebral body metastases unresponsive to conservative treatments had combined radiofrequency ablation and kyphoplasty.

    No complication occurred but an asymptomatic cement leakage noted in 1. Pain significantly decreased: the mean VAS pain score before treatment was 8 vs. 1.8 and 1.9 at 72 h and 6 weeks. Analgesic reduction was achieved in all.

    Larger studies with longer follow up added to table 2.

    Schafer O, Lohrmann C, Markmiller M et al (2003). Combined treatment of a spinal metastasis with radiofrequency heat ablation and vertebroplasty. Technical Innovation. AJR; 180:1075–1077

    Case report

    N=1 case of spinal metastases treated with radiofrequency ablation and vertebroplasty.

    Follow up 3 months

    A stable vertebral body with no further tumour growth reported. The patient was pain-free and had no limitations in his activity.

    Larger studies with longer follow up added to table 2.

    Saravana-Bawan S, David E, Sahgal A et al. (2019) Palliation of bone metastases—exploring options beyond radiotherapy. Ann Palliat Med;8(2):168-177.

    Review

    This educational review discusses safety, technique and indications for emerging technology in the area of locoregional treatment of bone metastases in conjunction with vertebral augmentation including RFA.

    Review

    Sayed D, Jacobs D, Sowder T et al (2019). Spinal Radiofrequency Ablation Combined with Cement Augmentation for Painful Spinal Vertebral Metastasis: A Single-Center Prospective Study. Pain Physician; 22:E441-E449

    Prospective study

    N=30 patients undergoing RFA with cement vertebral augmentation for a painful thoracic or lumbar vertebral metastases.

    Average NRS-11 scores decreased from a baseline of 5.77 to 4.65 (3 days; p = 0.16), 3.33 (one week; p<0.01), 2.64 (one month; p<0.01), and 2.61 (3 months; p<0.01). FACT-G7 increased from a baseline average of 13.0 to 14.7 (3 days; p=0.13), 14.69 (one week; p=0.15), 14.04 (one month; p=0.35), and 15.11 (3 months; p=0.07). No major adverse events were reported.

    Larger studies included in table 2.

    Sagoo NS, Haider AS, Chen AL, Vannabouathong C, Larsen K, Sharma R, Palmisciano P, Bin Alamer O, Igbinigie M, Wells DB, Aoun SG, Passias PG, and Vira S. Radiofrequency ablation for spinal osteoid osteoma: A systematic review of safety and treatment outcomes. Surgical Oncology. 2022;42:101747

    Systematic review on radiofrequency ablation (RFA) for painful spinal osteoid osteoma (OO).

    14 studies (354 patients)

    The estimated pain reduction on the numerical rating scale was 6.85/10 (95% confidence intervals [95%CI] 4.67–9.04) at a 12 to 24-month follow up; and 7.29/ 10 (95% CI 6.67–7.91) at a >24-month follow up (range 24 to 55 months). Protective measures (e.g., epidural air insufflation or neuroprotective sterile water infusion) were used in 43/354 (12.1%) patients. Local tumour progression was seen in 23/354 (6.5%) patients who were then successfully re-treated with RFA or open surgical resection. Grade I-II complications such as temporary limb paraesthesia and wound dehiscence were reported in 4/354 (1.1%) patients. No Grade III-V complications were reported.

    Not spinal metastasis.

    Senol N, Oguzoglu AS, Goksel HM. (2022) Radiofrequency Ablation and Augmentation in the Management of Spinal Metastases: Clinical Experience in 41 Patients. World neurosurgery; 163; e420-e425

    Retrospective case series

    N=41

    combined radiofrequency ablation and vertebral augmentation in patients with metastatic spinal tumours.

    Follow up 6 months.

    No serious complications were seen. 2 patients had transient neurological motor deficits without cement leakage, and 1 patient had a pulmonary embolism with transient mild symptoms. Significant pain control and good functional state were reported at 6 months follow up.

    Larger studies were included in the summary of evidence.

    Shawky A, Ahmed EA, Krajnovic B et al. (2021) Radiofrequency ablation and balloon kyphoplasty for palliation of painful spinal metastases. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society; 30 (10); 2874-2880

    Retrospective case series

    N=60 patients with 77 spinal metastases had RFA and Balloon kyphoplasty.

    Mean pre-procedure and post-procedure VAS for back pain was 7.2/10 and 2.7/10, respectively (p value = 0.0001). No neurological complications related to RFA were found and no cement extravasation into the spinal canal was observed. In two patients, asymptomatic leaks into the needle track, in two patients into draining veins and in one patient into the disk space were detected.

    Similar studies included in the summary of evidence.

    Tomasian A, Hillen TJ, Chang RO et al (2018). Simultaneous bipedicular radiofrequency ablation combined with vertebral augmentation for local tumor control of spinal metastases. AJNR Am J Neuroradiology 39:1768 –73

    Retrospective study

    N=27 patients (33 tumours) with vertebral metastases treated with simultaneous bipedicular radiofrequency ablation combined with vertebral augmentation.

    Posterior vertebral body or pedicle involvement or both

    present in 94% (31/33) of cases.

    Local tumour control was achieved in 96% (25/26) of tumours median follow up of 16 weeks. No complications were reported, and no patients had clinical evidence of metastatic spinal cord compression at the treated levels.

    Larger studies included in table 2.

    Wallace AN, Greenwood TJ, Jennings JW (2015). Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases. J Neurooncol; 124:111-118.

    Retrospective study

    N=72 patient with 110 spinal metastases.

    RFA and vertebral augmentation in 95% (105/110) ablations.

    Star tumour ablation system was used.

    Follow up 1 month

    Patients reported clinically significant decreased pain scores at both 1-week (mean, 3.9 ± 3.0; p<0.0001) and 4-week (mean, 2.9 ± 3.0; p<0.0001) follow-up. No major complications related to RFA and no cement extravasation reported.

    Study included in systematic review added to table 2.

    Wallace AN, Tomasian A, Vaswani D et al (2016). Radiographic local control of spinal metastases with percutaneous radiofrequency ablation and vertebral augmentation. AJNR Am J Neuroradiology; 37:759-765.

    Retrospective review (sub-group analysis)

    N=55 tumours reporting rate of radiographic local control in patients with spinal metastases treated with RFA and vertebral augmentation.

    Star tumour ablation system was used.

    Follow up 1 year in 93% (51/55) patients. (median 34 weeks)

    Radiographic local tumour control rates were 89% (41/46) at 3 months, 74% (26/35) at 6 months, and 70% (21/30) at 1 year. No complications were reported, and no patients had metastatic spinal cord compression at treated levels.

    Subgroup analysis of above study (included in systematic review added to table 2).

    Wang, F., Gu, J., Xu, C. et al. (2022) The combination of radiofrequency ablation and vertebroplasty shows advantages over single vertebroplasty in treating vertebral neoplastic lesions. Skeletal Radiol 51, 565–571 https://doi.org/10.1007/s00256-021-03788-7

    Retrospective comparative case series

    N=35 patients with vertebral neoplastic lesions who had RFA combined with vertebroplasty (group A, 15 patients with 17 lesions) or single vertebroplasty (group B, 20 patients with 24 lesions)

    VAS scores in group A decreased rapidly after 1 week and remained stable at 6 months than in group B (P < 0.05). The cement injected in group A (5.95 ± 1.45 mL) was significantly more than that in group B (4.09 ± 0.55 mL) (P < 0.05). The ratio of vascular cement leakage in group A was significantly lower than that in group B (P < 0.05), while no statistical difference was found in the non-vascular cement leakage (P > 0.05).

    Similar studies included in summary of evidence.

    Yang PL, He XJ, Li HP, et al. (2017). Image-guided minimally invasive percutaneous treatment of spinal metastasis. Exp Ther Med 13:705–9.

    Retrospective case series

    N=25 (32 vertebral lesions)

    RFA plus cement augmentation

    Follow up mean 7.8 months.

    Biomechanical stability of the spine increased, pain within 6 weeks reduced, while the daily activities and quality of life improved. Mean progression-free survival of tumours was 330±54 days, and no complications occurred.

    Study included in systematic review added to table 2.

    Yuntong M, Wallace AN, Madaelil TP et al (2016). Treatment of osseous metastases using the Spinal Tumor Ablation with Radiofrequency (STAR) system. e: Expert review of medical devices. VOL. 13, NO. 12, 1137–1145

    Review of epidemiology, pathophysiology, natural history, and traditional management of metastatic bone disease and Spinal Tumour Ablation with Radiofrequency (STAR) System for treatment of osseous metastases.

    Although evidence supporting the efficacy of RFA for the treatment of bone metastases is limited to case series, it is a reasonable therapy when other options have been exhausted, especially given the safety and minimal morbidity of the procedure. The STAR Tumor Ablation System has expanded the anatomic scope of bone metastases that can be safely and effectively treated with percutaneous ablation.

    Review

    Yevich S, Chen S, Metwalli Z (2021) Radiofrequency ablation of spine metastases: A clinical and technical approach. Seminars in musculoskeletal radiology; 25 (6); 795-804

    Review

    Article reviews the indications, clinical work-up, and technical approach for RFA of spine metastases.

    Review