Evidence map›Paper›PMID 40405317›Full record

ArticleJournal of orthopaedic surgery and research2025

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.

Hisham Elazaly, Ioanna Maria Dimitriou, Tazio Maleitzke, Michael Dahne, Vera Jaecker, Sven Maerdian, Sascha Tafelski, Torsten Diekhoff, Tobias Lindner, Doruk Akgün and 32 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of orthopaedic surgery and research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04543682 (A Phase I/IIa, Prospective, Mono-center, Randomized, Open Labeled, Controlled Study to Assess the Safety and Efficacy of Applying Iloprost Locally in the Fracture Site to Promote Bone Healing in Patients With Proximal Humeral Fracture), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04543682 phase1 / phase2unknown statusnot on this map

A Phase I/IIa, Prospective, Mono-center, Randomized, Open Labeled, Controlled Study to Assess the Safety and Efficacy of Applying Iloprost Locally in the Fracture Site to Promote Bone Healing in Patients With Proximal Humeral Fracture

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2022 to 2024Enrolled30ConditionsProximal Humeral FractureArms0.125 ng/kg/min Iloprost, 0.25 ng/kg/min Iloprost, open reduction and internal fixation with an angular stable plate (PHILOS)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Hisham ElazalyCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Ioanna Maria DimitriouBerlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany.
Tazio MaleitzkeCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Michael DahneCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Vera JaeckerCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sven MaerdianCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sascha TafelskiCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Torsten DiekhoffDepartment of Radiology, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Tobias LindnerEmergency Department, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Doruk AkgünCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Anna-Maria MielkeCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Alp PaksoyCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Dominik Adl AminiCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Elisa Marie PlanatscherCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Vincent LeopoldCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Susana González-KhatibCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Paul Christoph KöhliCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Marcel NiemannCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Alexander HildebrandtCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Stephan OehmeCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Yannick PalmowskiCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Melissa ParaskevaidisCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Lukas SchönnagelCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sebastian Benedict BraunCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Matthias PumbergerCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sebastian HardtCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sigmar StrickerDepartment of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany.
Levent AkyüzBerlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany.
Gerald GrützBerlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany.
Stefan SchallerCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Luis LauterbachCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Maximilian VolcksdorffCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Lukas MödlInstitute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Martin TextorCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Melanie OrtCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Simon ReinkeCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Ulrich StöckleCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Carsten PerkaCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Georg N DudaCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Katharina Schmidt-BleekCenter for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Sven Geissler *Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Tobias Winkler *Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. tobias.winkler@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProximal 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.

methodsThirty 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 registrationThe 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 .

Indexed as

Fracture Fixation, InternalFracture HealingIloprostShoulder FracturesAgedClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFeasibility StudiesFemaleHumansMaleMiddle AgedPilot ProjectsRandomized Controlled Trials as TopicIloprostBone healingFracture repairIlomedinIloprostPHILOSProximal humerus fracture

Identifiers

PMID40405317
PMCPMC12096472

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Registered trials

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