Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04543682
Status:
RECRUITING
Last Update Posted:
2022-11-03
First Post:
2020-09-02
Brief Title:
A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
A Phase IIIa 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
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ilobone
Brief Summary:
The main objective of this study is to establish the safety as well as the efficacy of local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture
The study will have two treatment groups and one control group All patients will receive the standard of care procedure reduction and angular stable PHILOS plate fixation The two treatment groups will additionally be treated with two different Iloprost doses
Subjects will be assessed for study eligibility within 24h after admission screening period Eligible subjects will be assessed for baseline parameters on day 0 Within 96 hours of the study subjects will undergo surgery reduction and angular stable PHILOS plate fixation During the procedure a catheter will be inserted in the fracture site of the treatment groups in order to deliver the Iloprost locally in the fracture site
The expected total duration of study participation for each subject comprises 52 weeks among which 26 weeks include active study participation At the study end a telephone call with the subjects will be performed for safety assessment Recruitment will be completed in approximately 18 months
Follow up visits following the surgical operation shall take place during weeks 3 6 12 and 26 The last follow-up will be a phone call during week 52 for the purpose of safety assessment
The study will have two treatment groups and one control group All patients will receive the standard of care procedure reduction and angular stable PHILOS plate fixation The two treatment groups will additionally be treated with two different Iloprost doses
Subjects will be assessed for study eligibility within 24h after admission screening period Eligible subjects will be assessed for baseline parameters on day 0 Within 96 hours of the study subjects will undergo surgery reduction and angular stable PHILOS plate fixation During the procedure a catheter will be inserted in the fracture site of the treatment groups in order to deliver the Iloprost locally in the fracture site
The expected total duration of study participation for each subject comprises 52 weeks among which 26 weeks include active study participation At the study end a telephone call with the subjects will be performed for safety assessment Recruitment will be completed in approximately 18 months
Follow up visits following the surgical operation shall take place during weeks 3 6 12 and 26 The last follow-up will be a phone call during week 52 for the purpose of safety assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003813-24 | EUDRACT_NUMBER | None | None |