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Background <p>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.</p> Methods <p>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.</p> Discussion <p>The Ilobone study aims to provide data on the potential for biological augmentation of osteosynthesis procedures in PHFs, prone to healing challenges and complications.</p> Trial registration <p>The trial is registered with ClinicalTrial.gov (NCT04543682), registered 02 Sep. 2020, <a href="https://clinicaltrials.gov/show/NCT04543682">https://clinicaltrials.gov/show/NCT04543682</a> and the German Clinical Trials Registry (DRKS00027081), registered 10 Nov. 2021 <a href="https://drks.de/search/de/trial/DRKS00027081">https://drks.de/search/de/trial/DRKS00027081</a>.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月22日

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  • Hisham Elazaly,
  • Ioanna Maria Dimitriou,
  • Tazio Maleitzke,
  • Michael Dahne,
  • Vera Jaecker,
  • Sven Maerdian,
  • Sascha Tafelski,
  • Torsten Diekhoff,
  • Tobias Lindner,
  • Doruk Akgün,
  • Anna-Maria Mielke,
  • Alp Paksoy,
  • Dominik Adl Amini,
  • Elisa Marie Planatscher,
  • Vincent Leopold,
  • Susana González-Khatib,
  • Paul Christoph Köhli,
  • Marcel Niemann,
  • Alexander Hildebrandt,
  • Stephan Oehme,
  • Yannick Palmowski,
  • Melissa Paraskevaidis,
  • Lukas Schönnagel,
  • Sebastian Benedict Braun,
  • Matthias Pumberger,
  • Sebastian Hardt,
  • Sigmar Stricker,
  • Levent Akyüz,
  • Gerald Grütz,
  • Stefan Schaller,
  • Luis Lauterbach,
  • Maximilian Volcksdorff,
  • Lukas Mödl,
  • Martin Textor,
  • Melanie Ort,
  • Simon Reinke,
  • Ulrich Stöckle,
  • Carsten Perka,
  • Georg N. Duda,
  • Katharina Schmidt-Bleek,
  • Sven Geissler,
  • Tobias Winkler

摘要

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.