伊洛前列素治疗：一项评估局部伊洛前列素治疗促进肱骨近端骨折愈合的安全性和可行性的I/IIa期随机对照试验——一项初步研究设计
ILOBONE: A phase I/IIa randomized controlled trial to assess the safety and feasibility of local iloprost therapy for enhancing proximal humerus fracture healing- a pilot study design.
作者信息
Elazaly Hisham, Dimitriou Ioanna Maria, Maleitzke Tazio, Dahne Michael, Jaecker Vera, Maerdian Sven, Tafelski Sascha, Diekhoff Torsten, Lindner Tobias, Akgün Doruk, Mielke Anna-Maria, Paksoy Alp, Amini Dominik Adl, Planatscher Elisa Marie, Leopold Vincent, González-Khatib Susana, Köhli Paul Christoph, Niemann Marcel, Hildebrandt Alexander, Oehme Stephan, Palmowski Yannick, Paraskevaidis Melissa, Schönnagel Lukas, Braun Sebastian Benedict, Pumberger Matthias, Hardt Sebastian, Stricker Sigmar, Akyüz Levent, Grütz Gerald, Schaller Stefan, Lauterbach Luis, Volcksdorff Maximilian, Mödl Lukas, Textor Martin, Ort Melanie, Reinke Simon, Stöckle Ulrich, Perka Carsten, Duda Georg N, Schmidt-Bleek Katharina, Geissler Sven, Winkler Tobias
机构信息
Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany.
出版信息
J Orthop Surg Res. 2025 May 22;20(1):498. doi: 10.1186/s13018-025-05865-2.
BACKGROUND
Proximal humerus fractures (PHFs) are the third most common fractures in elderly patients. Over 70% of PHFs in patients aged over 60 are displaced fractures, often necessitating surgical treatment. However, osteosynthesis is associated with a high rate of complications, highlighting the urgent need for additional therapeutic approaches to enhance bone healing and prevent osteonecrosis. This study evaluates the safety, feasibility and potential efficacy of local prostacyclin (iloprost) to improve bone healing in patients with PHFs.
METHODS
Thirty eligible patients will be randomized into one of three groups at a 1:1:1 ratio. All patients will receive angular stable locking plate fixation. Two treatment groups will receive an additional single dose of local iloprost through a 24-hour infusion postoperatively (group 1: low dose; group 2: high dose), while the control group will only receive the osteosynthesis. Patients will be monitored for 52 weeks. The primary endpoint is safety, with secondary endpoints including the preservation of the screw tip apex distance as an indicator of fracture healing, head shaft angle, necrosis rate, and patient-related outcome measures.
DISCUSSION
The Ilobone study aims to provide data on the potential for biological augmentation of osteosynthesis procedures in PHFs, prone to healing challenges and complications.
TRIAL REGISTRATION
The trial is registered with ClinicalTrial.gov (NCT04543682), registered 02 Sep. 2020, https://clinicaltrials.gov/show/NCT04543682 and the German Clinical Trials Registry (DRKS00027081), registered 10 Nov. 2021 https://drks.de/search/de/trial/DRKS00027081 .
背景
肱骨近端骨折（PHF）是老年患者中第三常见的骨折。60岁以上患者中超过70%的PHF为移位骨折，通常需要手术治疗。然而，骨合成与高并发症发生率相关，这凸显了迫切需要其他治疗方法来促进骨愈合和预防骨坏死。本研究评估局部前列环素（伊洛前列素）在改善PHF患者骨愈合方面的安全性、可行性和潜在疗效。
方法
30名符合条件的患者将按1:1:1的比例随机分为三组之一。所有患者均接受角稳定锁定钢板固定。两个治疗组将在术后通过24小时输注额外给予单剂量局部伊洛前列素（第1组：低剂量；第2组：高剂量），而对照组仅接受骨合成治疗。对患者进行52周的监测。主要终点是安全性，次要终点包括作为骨折愈合指标的螺钉尖顶距离的保留、头干角、坏死率以及与患者相关的结局指标。
讨论
伊洛骨研究旨在提供关于在易于出现愈合挑战和并发症的PHF中骨合成程序生物增强潜力的数据。
试验注册
该试验已在ClinicalTrial.gov（NCT04543682）注册，于2020年9月2日注册，网址为https://clinicaltrials.gov/show/NCT04543682 ，并在德国临床试验注册中心（DRKS00027081）注册，于2021年11月10日注册，网址为https://drks.de/search/de/trial/DRKS00027081 。
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