Local Iloprost Therapy to Promote Bone Healing in High Risk Fractures
NCT07924722, Phase 2, Not yet recruiting, Charite University, Berlin, Germany
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Local Iloprost Therapy to Promote Bone Healing in High Risk Fractures | ClinicalTrials.gov |
| NCT number | NCT07924722 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Charite University, Berlin, Germany | ClinicalTrials.gov |
| Conditions | Nonunion Bone Fracture, Fractures Ununited, Fractures | ClinicalTrials.gov |
| Interventions | Ilomedin, Normal saline placebo | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Radiological fracture healing status at Week 18 assessed by CT | From enrollment to week 18 after surgery | 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). | ClinicalTrials.gov |
| Secondary | Radiological assessment of fracture healing at week 18, and 36 post-surgery (RUSH) | From enrollment to week 36 after surgery | 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. | ClinicalTrials.gov |
| Secondary | Radiological assessment of fracture healing at week 18, and 36 post-surgery (mRUST) | From enrollment to week 36 after surgery | 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. | ClinicalTrials.gov |
| Secondary | Radiological assessment of fracture healing at week 18, and 36 post-surgery (2D binary) | From enrollment to week 36 after surgery | 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. | ClinicalTrials.gov |
| Secondary | Improvement of pain at week 6, 18, 36, and 52, assessed by VAS pain scores | From enrollment to week 52 after surgery | 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). | ClinicalTrials.gov |
| Secondary | Improvement of health-related quality of life at week 6, 18, 36, and 52, assessed by EQ-5D-5L | From enrollment to week 52 after surgery | 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. | ClinicalTrials.gov |
| Secondary | Improvement physical function at week 6, 18, 36, and 52, assessed by SMFA | From enrollment to week 52 after surgery | 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. | ClinicalTrials.gov |
| Secondary | Return-to-work at week 6, 18, 36, and 52 | From enrollment to week 52 after surgery | 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. | ClinicalTrials.gov |
| Secondary | 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)) | From enrollment to week 52 after surgery | 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 | ClinicalTrials.gov |
| Other | CT-derived objective radiological parameters of fracture repair and callus formation (bone volume/ total volume) | Enrollment to week 18 after surgery | Exploratory CT-derived, callus-related radiological parameters at Week 18 (bone volume/ total volume in callus). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)