Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial

Abstract

IntroductionMultiple myeloma (MM) is a plasma cell cancer where about 1/3 of the patients present with pathological fractures at the time of diagnosis. Despite treatment, the majority of the patients will develop additional fractures. Because survival and prognosis has improved significantly over the last two decades for patients with MM, there is an increased need to focus on optimal fracture treatment. Traditionally, fracture pain is treated conservatively with opioids, bisphosphonates, bracing and radiation therapy. Vertebral augmentation has been used for the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for the efficacy is weak. We describe a trial assessing the impact of vertebroplasty on clinical outcome in the treatment of patients with MM with painful vertebral fractures.Methods100 patients with MM with painful vertebral fractures will be randomised in a prospective, single-blinded, multicentre, clinical trial where patients are randomised to either usual care or usual care supplemented with vertebroplasty with a possibility of crossover 4 weeks after randomisation. The primary outcome will be change in Oswestry Disability Index at 4 weeks.AnalysisPrimary and secondary outcomes are assessed at baseline and at 4, 8, 26 and 52 weeks. Categorical data will be presented by means of frequencies and related percentages; continuous data will be displayed by means of descriptive statistics.Ethics and disseminationThe study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20200075) and notified and approved by the Region of Southern Denmark and listed in the internal record, journal no. 20/22355. All participants provide consent. The protocol will follow the SPIRIT (Standard Protocol Items for Randomized Trials) statement. The Danish Myeloma Patient Organization supports the study. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences.Trial registration numberNCT04533217.

The Role of Vertebral Augmentation Procedures in the Management of Multiple Myeloma

“…Wickstroem et al are conducting a single-blinded, multi-center clinical trial of around 100 patients with MM who had painful vertebral fractures and were randomized to either standard conservative care or standard conservative care with VAP, with the possibility of cross-over within 4 weeks of randomization. 57 This will be the first nationwide randomized controlled study, and the outcomes will have an impact on the guidelines of patients with MM and painful VCFs.…”

“…It was concluded that adding RFA to PVP provided no extra mid-term pain benefit; however, it increased procedure cost and time 56. ONGOING STUDIESWickstroem et al are conducting a single-blinded, multicenter clinical trial of around 100 patients with MM who had painful vertebral fractures and were randomized to either standard conservative care or standard conservative care with VAP, with the possibility of cross-over within 4 weeks of randomization 57. This will be the first nationwide randomized controlled study, and the outcomes will have an impact on the guidelines of patients with MM and painful VCFs.CONCLUSIONSVAPs are minimally invasive, safe, and effective for the treatment of VCFs in patients with MM.…”

Novel Developments in the Treatment of Multiple Myeloma-Associated Bone Disease

“…However, the number of high-quality studies to uncover the full impact of the procedures is still low. Presently, a single-blinded, randomized clinical trial is being conducted to compare the outcomes of standard care alone versus standard care supplemented with vertebroplasty (clinicaltrials.gov: NCT04533217, accessed on 1 November 2023) [83]. Wedge osteotomy can be considered in cases where severe kyphotic deformity affects the patient's activi-ties of daily living.…”

Instrumental Evaluation of the Effects of Vertebral Consolidation Surgery on Trunk Muscle Activations and Co-Activations in Patients with Multiple Myeloma: Preliminary Results

“…MM’s clinical features and the effects they have on motor function necessitate thorough patient care regarding every day and occupational activities including getting out of a chair and lifting objects [ 4 , 6 ]. In the 7.8% of patients with MM who have vertebral collapses, vertebroplasty surgery can be performed to biomechanically stabilize the microfractures, relieve pain, and prevent the spine from experiencing further damage [ 1 , 2 , 4 , 7 ]. Among the main surgical procedures, percutaneous vertebroplasty offers patients significant and long-lasting pain alleviation [ 8 , 9 ].…”