骨瘤冷冻消融术后市场研究（OPuS One）是一项前瞻性、多国家和单臂研究，旨在调查射频消融（RFA）对于治疗疼痛性溶骨转移的安全性和有效性，随访为12个月。RFA已经在小规模的临床研究中证明对于骨转移起到了有效的缓解作用，但是缺乏较为牢固的研究数据来进行长期评估。前瞻性的评估在基线、术后3天、1周、1、3、6和12个月分别进行，使用疼痛简短问卷、欧洲生命质量-5维和欧洲研究和治疗癌症组织关心疗护质量问卷对疼痛和生命质量进行评估。收集了放疗、化疗和阿片使用情况和相关不良事件。OPuS One在15个机构中共治疗了206名受试者。从术后3天开始的最糟糕疼痛、平均疼痛、疼痛干扰和生命质量都显著改善，并持续到12个月（P ＜ 0.0001）。后续分析发现，全身化疗和局部放疗不影响消融术对于最糟糕疼痛、平均疼痛或者疼痛干扰的缓解。六名受试者出现了设备/手术相关的不良事件。RFA治疗溶骨转移提供了快速（3天内）和统计学显著的疼痛和生命质量的改善，可以持续到12个月，并且具有很高的安全性，与放疗无关。（2B、前瞻性、非随机、后市场研究：本杂志要求作者为每篇文章分配一个证据水平。有关这些基于证据的医学评估的详细说明，请参阅目录或在线作者说明www.springer.com/00266. © 2023.作者）

The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12 months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking.Prospective assessments were conducted at Baseline, 3 days, 1 week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life-5 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected.206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3 days post-RFA and sustained to 12 months (P < 0.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device/procedure-related adverse events.RFA for lytic metastases provides rapid (within 3 days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12 months and a high degree of safety, independent of radiation.2B, PROSPECTIVE, NON-RANDOMIZED, POST-MARKET STUDY: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .© 2023. The Author(s).