Department of Orthopedics and Traumatology of Luzerner Kantonsspital, Lucerne, Switzerland.
Faculty of Health Science and Medicine of University of Lucerne, Lucerne, Switzerland.
Trials. 2024 Jul 30;25(1):513. doi: 10.1186/s13063-024-08350-z.
The incidence of fragility fractures of the pelvis is rising. Whereas the treatment for FFP type I, III, and IV is clear, the optimal treatment for FFP type II remains a topic of discussion. Traditionally these fractures have been treated conservatively. However, there is a shift toward early surgical stabilization with percutaneous screw fixation to reduce pain and promote mobility in an already frail patient population. High-quality evidence, however, is lacking. Therefore, a randomized clinical trial was designed to compare conservative management to early percutaneous screw fixation in patients with type II fragility fractures.
This is a monocenter randomized controlled trial. All patients with a FFP type II are screened for inclusion. After obtaining informed consent, patients are randomized between conservative management and surgical stabilization. Conservative management consists of early mobilization under guidance of physiotherapy and analgesics. Patients randomized for surgical treatment are operated on within 72 h using percutaneous screw fixation. The primary endpoint is mobility measured by the DEMMI score. Secondary endpoints are other dimensions of mobility, pain levels, quality of life, mortality, and morbidity. The total follow-up is 1 year. The required sample size is 68.
The present study aims to give certainty on the potential benefit of surgical treatment. Current literature on this topic remains unclear. According to the volume of FFP at the study hospital, we assume that the number of patients needed for this study is gathered within 2 years.
ClinicalTrials.gov NCT04744350. Registered on February 8, 2021.
骨盆脆性骨折的发病率正在上升。虽然 FFP 型 I、III 和 IV 的治疗方法明确，但 FFP 型 II 的最佳治疗方法仍存在争议。传统上，这些骨折采用保守治疗。然而，现在有一种趋势是早期采用经皮螺钉固定的手术稳定化治疗，以减轻疼痛并促进已经脆弱的患者群体的活动能力。然而，缺乏高质量的证据。因此，设计了一项随机临床试验，旨在比较保守治疗与早期经皮螺钉固定治疗 II 型脆性骨折患者的效果。
这是一项单中心随机对照试验。所有 FFP 型 II 患者都进行了筛选以纳入研究。获得知情同意后，患者在保守治疗和手术稳定化之间进行随机分组。保守治疗包括在物理治疗和镇痛的指导下早期活动。随机接受手术治疗的患者在 72 小时内进行经皮螺钉固定手术。主要终点是通过 DEMMI 评分测量的活动能力。次要终点是其他活动能力维度、疼痛水平、生活质量、死亡率和发病率。总随访时间为 1 年。所需的样本量为 68 例。
本研究旨在确定手术治疗的潜在益处。目前关于这个主题的文献仍然不清楚。根据研究医院的 FFP 量，我们假设这项研究需要的患者数量可以在 2 年内收集到。
ClinicalTrials.gov NCT04744350. 注册于 2021 年 2 月 8 日。
