A Phase 2 interventional study of Ilomedin and Normal saline placebo in Nonunion Bone Fracture, Fractures Ununited and Fractures, sponsored by Charite University, Berlin, Germany. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Charite University, Berlin, Germany · Phase 2, Interventional, and Treatment
What is this study about? When a bone breaks, it usually heals within a few months. In some people, however, the bone does not heal properly (a "non-union"), which can mean ongoing pain, more surgery, and a longer time off work.
This study tests whether a single, local treatment with a medicine called iloprost, given right at the fracture site, can help bones heal better in people who are more likely to have healing problems.
Who can take part? Patients who need surgery to fix a broken bone and who are at higher risk of poor healing. A blood test before surgery measures a certain type of immune cell (CD8+ TEMRA cells). A high level (38% or more) indicates a higher risk. About 533 people will be tested to find 60 participants.
What happens during the study:
Surgery: Everyone receives the standard operation to fix the bone. During surgery, a thin, soft tube (catheter) is placed near the fracture, similar to those routinely used to deliver pain medication to wounds.
Groups: Participants are assigned by chance (like a coin toss) to one of two equal groups:
Group 1: iloprost through the tube for 24 hours Group 2: a harmless salt-water solution (placebo) for 24 hours Timing: In both groups, salt water runs for the first 24 hours after surgery. The next 24 hours bring either iloprost or placebo. Treatment lasts 48 hours in total.
Blinding: Participants, doctors, nurses, and the people who assess the results do not know who receives which treatment. Only the pharmacy staff who prepare the infusions know, and they are not involved in patient care. This keeps the results fair and unbiased.
What happens afterwards?
Participants are followed for about one year (52 weeks), with clinic visits at weeks 6, 18, and 36 and a phone call at week 52.
How will we know if it worked? The main question is whether the bone has healed by week 18, as seen on a CT scan. The study also looks at bone healing at week 36, pain, physical function, quality of life, return to work, and changes in immune cells and blood markers, which help explain how the treatment works.
How is safety monitored? All side effects are recorded and compared between the two groups to see how safe and well tolerated the treatment is.
Why does this matter? Currently, there are few ways to prevent healing problems before they occur. If the treatment works, it could help patients heal faster and avoid further operations. This is an early-stage (phase II) study at a single center. It can show whether the treatment is promising, but it cannot yet prove that it should become standard care.
Musculoskeletal injuries represent a major global health burden, with bone fractures accounting for a substantial proportion of trauma-related morbidity. Approximately 160-190 million fractures occur annually worldwide. Studies have estimated that up to 25% of the population in USA may experience a musculoskeletal injury within a year. The fracture incidence in Germany has increased by 14% over the past decade, reaching an incidence of 1,014 fractures per 100,000 persons per year in 2019. Although bone has a remarkable endogenous capacity for regeneration, fracture healing remains impaired in a clinically relevant proportion of patients. Despite advances in surgical fixation and fracture management, reliable strategies for the early identification of patients at increased risk of compromised fracture healing and corresponding targeted interventions remain limited. Current clinical management largely relies on identifying delayed or failed healing after it has already occurred, followed by additional surgical or biological interventions. Increasing evidence indicates that the individual immune response is an important determinant of bone regeneration. Among the adaptive immune cell populations involved in bone regeneration, highly differentiated CD8+ effector T cells have emerged as particularly relevant mediators of impaired fracture healing. Terminally differentiated CD8+ T cells (hereafter referred to as CD8+ TEMRA cells and defined as CD3+CD8+CD28-CD57+ T cells) accumulate in high numbers in the early fracture hematoma of patients with compromised healing. These cells are the major producers of the pro-inflammatory cytokines TNF-α and IFN-y at the fracture site, which negatively affect osteogenic differentiation and survival of human endochondral progenitor cells. Functional experiments further demonstrated that depletion of CD8+ T cells improves bone regeneration, whereas adoptive transfer of CD8+ T cells impairs healing.
Iloprost is a synthetic prostacyclin analogue and agonist of the prostacyclin receptor. Activation of this Gαs-coupled receptor increases intracellular cAMP. In the context of fracture healing, local iloprost administration is intended to transiently modulate an unfavorable proinflammatory immune environment during the early phase of bone regeneration. Preclinical work demonstrated that local iloprost administration reduced proinflammatory CD8+ effector T cell activity, their cytokine secretion, and improved bone regeneration in vivo. Iloprost also modulates macrophage responses and may support regulatory immune mechanisms through cAMP-dependent signaling. Together, these effects are proposed to facilitate the transition from a persistent pro inflammatory state toward a local environment that supports angiogenesis, osteogenic differentiation, and bone regeneration. PRECISION evaluates whether local iloprost-mediated immunomodulation improves fracture healing in a prospectively selected population with an increased risk of compromised fracture healing. The purpose of the trial is to evaluate whether local iloprost administration improves fracture healing in patients prospectively identified as having an increased risk of compromised fracture healing based on elevated preoperative CD8+ TEMRA levels. PRECISION builds on preclinical evidence supporting local iloprost-mediated immunomodulation, clinical safety and feasibility experience with the catheter-based administration strategy from the preceding ILOBONE Phase I/IIa trial, and prospective clinical evidence from BioBone supporting CD8+ TEMRA-based risk enrichment.
43 studies on the registry are indexed under Fractures, Ununited; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 27 interventional studies indexed under Fractures, Ununited.
Browse Fractures, Ununited studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible fracture according to AO classification:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Iloprost
Drug: Ilomedin
Normal saline (0.9% NaCl)
Other: Normal saline placebo
Iloprost administered locally through the catheter. • Infusion rate: 0.25 ng/kg/min; Duration: 24 ± 1 hours.
Administered through the catheter. • Identical infusion duration: 24 ± 1 hours.
Radiological fracture healing status at Week 18 assessed by CT
Fracture healing will be classified as a binary outcome: Healed (trabecular bridging ≥50% and/or full cortical continuity) versus Non-healed (trabecular bridging \<50% or persistent fracture line).
Time frame: From enrollment to week 18 after surgery
Radiological assessment of fracture healing at week 18, and 36 post-surgery (RUSH)
Radiographic Union Score for Hip score (RUSH), where applicable, The RUSH score quantifies four parameters of fracture healing: cortical bridging, cortical fracture line disappearance, trabecular consolidation, and trabecular fracture line disappearance. The total score ranges from 10 (no consolidation) to 30 (complete healing), with higher scores indicating more advanced healing. The RUSH score improves interobserver agreement and provides a structured approach for evaluating hip fracture radiographs. It may also offer prognostic diagnostic value for assessing healing outcomes in patients with proximal femoral fractures.
Time frame: From enrollment to week 36 after surgery
Radiological assessment of fracture healing at week 18, and 36 post-surgery (mRUST)
Modified Radiographic Union Score for Tibial fractures (mRUST), where applicable. The mRUST score evaluates fracture healing by assessing four cortices (anterior, posterior, medial, and lateral) on two radiographic views (AP and lateral). Each cortex is scored as follows: Score = 1, no callus, fracture line is visible, Score = 2, callus present, no bridging, fracture line visible Score = 3, bridging callus, fracture line visible Score = 4, bridging callus with no visible fracture line The total score ranges from 4 (no healing) to 16 (complete healing). Its simplicity and systematic structure make it particularly useful for identifying delayed- or non-union, as lower scores are more likely to require revision surgery.
Time frame: From enrollment to week 36 after surgery
Radiological assessment of fracture healing at week 18, and 36 post-surgery (2D binary)
Fracture healing status at Week 18, and 36 assessed by X-ray Fracture healing will be classified as a binary outcome: Healed (bridging of at least 3 of 4 cortices in 2 orthogonal views) versus Non-healed (bridging of 2 or less of 4 cortices in 2 orthogonal views). Conventional plain radiography is the first-line imaging modality for fracture evaluation. Standard images will be obtained in anteroposterior (AP), lateral, and oblique views where indicated to assess fracture pattern, classification, and treatment. No additional radiographs beyond SoC follow-up imaging will be performed.
Time frame: From enrollment to week 36 after surgery
Improvement of pain at week 6, 18, 36, and 52, assessed by VAS pain scores
Pain is assessed using the VAS, consisting of 10 cm line ranging from 'no pain' to 'worst imaginable pain'. Patients mark their respective pain level, which is recorded in millimeters (0-100).
Time frame: From enrollment to week 52 after surgery
Improvement of health-related quality of life at week 6, 18, 36, and 52, assessed by EQ-5D-5L
QoL is assessed using EuroQol-5 Dimension (EQ-5D), a validated and widely used instrument. It evaluates five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: From enrollment to week 52 after surgery
Improvement physical function at week 6, 18, 36, and 52, assessed by SMFA
The Short Musculoskeletal Function Assessment (SMFA) is a validated patient-reported outcome measure assessing physical function in patients with musculoskeletal disorders. It consists of 46 items scored on a 5-point Likert scale, with higher scores indicating worse function. The instrument includes two main indices: a) function index (physical capability) and b) bother index (impact of functional limitations). Scores for both indices range from 0 (best function) to 100 (worst function). The SMFA is a shorter version of the Musculoskeletal Function Assessment (MFA) and is designed for improved clinical usability. It has been translated and cross-culturally validated across multiple populations.
Time frame: From enrollment to week 52 after surgery
Return-to-work at week 6, 18, 36, and 52
Return-to-work status and time to return to work will additionally be documented during follow-up visits as exploratory indicators of functional recovery and socioeconomic outcome.
Time frame: From enrollment to week 52 after surgery
Incidence, severity, and relationship of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE (Version Number V6.0))
Events not meeting the AE definition: Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are associated with the underlying disease, unless judged by the Investigator to be more severe than expected for the participant's condition: * The disease/disorder being studied, or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the participant's condition * Medical or surgical procedure (e.g., fracture surgery, endoscopy, appendectomy): the condition that leads to the procedure is the AE * Situations in which an untoward medical occurrence did not occur (social and/or convenience admission to a hospital) * Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the trial that do not worsen
Time frame: From enrollment to week 52 after surgery
CT-derived objective radiological parameters of fracture repair and callus formation (bone volume/ total volume)
Exploratory CT-derived, callus-related radiological parameters at Week 18 (bone volume/ total volume in callus).
Time frame: Enrollment to week 18 after surgery
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iloprost
Charite University, Berlin, Germany →