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A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture (Ilobone)

Primary Purpose

Proximal Humeral Fracture

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
0.125 ng/kg/min Iloprost
0.25 ng/kg/min Iloprost
open reduction and internal fixation with an angular stable plate (PHILOS)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring proximal humeral fracture, proximale Humerusfraktur, Ilomedin, Iloprost

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent.
  • Adult male or female subjects between 60 to 80 years old at the time of screening visit.
  • Scheduled Proximal Humerus Internal Locking System (PHILOS) with 3 holes plate length for proximal humerus fracture type 3 or 4 according to Neer classification.
  • Patient with American Society of Anesthesiologists (ASA) score of ≤ 2.
  • Single, low energy fracture.
  • Absence of neurovascular complications at the time of trauma.
  • Surgery done within the first 96 hours from injury.

Exclusion Criteria:

  • Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
  • Immunosuppression due to illness or medication.
  • Subject with malignancy and undergoing treatment including chemotherapy, radiotherapy or immunotherapy.
  • Known allergies to Iloprost.
  • Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers, or intracranial hemorrhage).
  • Severe coronary heart disease or unstable angina; myocardial infarction within the last six months; decompensated cardiac failure if not under close medical supervision; severe arrhythmias; suspected pulmonary congestion; cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
  • Acute or chronic congestive heart failure (NYHA II-IV)
  • Pulmonary hypertension due to venous occlusive disease.
  • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
  • Subject who is currently enrolled in or has not yet completed a period of at least ( a period of time equal to 5 times as the half-life time of the drug used in the previous trial) since ending other investigational device or drug trial(s).
  • Patients who are dependent on the sponsor, investigator or study site.
  • History of previous proximal humerus surgery on the same side.
  • History of proximal humerus deformity on the same side.
  • Pathological or open fracture.
  • Polytrauma patient.
  • Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1).
  • Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
  • Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities.
  • Patients with a history of cerebral circulatory disorders.
  • Patients with any symptomatic or treatable heart disease (including stenting), hypertension treated with a β-receptor blocker, calcium agonists, vasodilator or ACE (Angiotensin-converting-enzyme) inhibitor at more than moderate doses.

Sites / Locations

  • Center for Muskuloskeletal Surgery, Charité - Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

First intervention group (0.125 ng/kg/min Iloprost)

Second intervention group (0.25 ng/kg/min Iloprost)

Control intervention group

Arm Description

The first intervention group will receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.125 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. The catheter will be inserted during the surgical procedure. Infusion of Iloprost will start 24hrs post-operatively and the dose will be delivered over 24h.

The second intervention group will also receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.25 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. Infusion will start 24hrs post-operatively and the dose will be delivered over 24h.

Control intervention: Patients will receive the standard of care procedure for such fractures, i.e. standard of care open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes).

Outcomes

Primary Outcome Measures

Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Efficacy analysis using the Tip Apex Distance (TAD) readout
TAD is an indicator of the progress of fracture healing and the probability of potential complications. Thus, it reflects both the safety and efficacy of the investigational treatment. To evaluate the treatment success rate, we will calculate the percentage loss of the summation of TADs of all locking screws. The value will be classified into one of five ranks as measured after 12 weeks of postoperative follow-up compared to the baseline measurement. For the percentage of original Tip Apex Distance, the sum of the Tip Apex Distance of the humeral head screws will be used: Grade 1: 76%-100% preservation of the original distance (representing the best possible result), Grade 2: 51%-75% preservation of the original distance, Grade 3: 26%-50% preservation of the original distance, Grade 4: 0%-25% preservation of the original distance, and Grade 5: if the patient shows signs of screw protrusion (cut out). Grade 1 will be considered as treatment success, grades 2-5 as treatment failure.

Secondary Outcome Measures

Rate of humeral head necrosis
Osteonecrosis of the humeral head is a common complication in proximal humerus fracture. (1) The occurrence of osteonecrosis varies significantly according to the grading of the fracture in addition to the initial displacement (valgus or varus), Soft tissue handling during surgical fixation can influence the rate of osteonecrosis (2,3). Both a radiologist and an orthopedic surgeon will confirm the diagnosis of osteonecrosis of the humeral head radiologically at 12th-week and 26th-week visits.
Humeral head shaft angle
Humeral head shaft angle is used to plan corrective osteotomies and shoulder arthroplasties as well as to evaluate the postoperative x-ray outcome, as a varus displacement of more than 10 degrees in the X-ray view is considered as loss of fixation (4).
Pain assessment using the Visual Analogue Scale (VAS)
The VAS instrument consists of a 10 cm long straight line with defined endpoints, ranging from 'no pain' to 'pain as bad as it could be.' The patient will be asked to mark the respective pain level on the line that is felt subjectively. The distance between 'no pain' and the marked pain level determines the patient's pain. Scores are given in mm, ranging from 0-100 (5).
Quality-of-Life (QoL) by applying EQ-5D
Patients will be asked to answer the questionnaire EuroQol-5 Dimension (EQ-5D), which is a validated instrument determining the quality of life as a health outcome. Developed in Europe, it is widely applied. The tool offers 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (6). The questionnaire includes a visual analog scale where patients can give information on their health state.
Constant-Murley Score (CMS):
The Constant-Murley Score (CMS) is a 100-points scale composed of different parameters to define the level of pain and the ability of the patient to perform normal daily activities. It is used to determine the functional outcome after treatment of shoulder injuries. The higher the score, the better the function of the shoulder is. CMS is divided into four main subscales: pain (max. 15 points), strength (max. 25 points), daily activity (max. 20 points) and range of motion (40 points). The European Society of Shoulder and Elbow Surgery (ESSE) has promoted the Constant- Murley Score as a gold standard for the assessment of shoulder function (7-9). The Constant-Murley Score takes patient sex and age into consideration. The score can be used relative to age and sex (10).
Disabilities of the Arm, Shoulder and Hand score (DASH)
DASH is a 30-item questionnaire that determines the ability of a patient to perform certain upper extremity activities. DASH questionnaire is self-reported, where patients can rate the difficulty and interference with daily life (1 = no difficulty or no symptom, 5 = unable to perform or very severe symptom). Subsequently, a score is calculated using a formula. A DASH score of 0 corresponds to no disability and 100 to extreme disability.

Full Information

First Posted
September 2, 2020
Last Updated
October 31, 2022
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04543682
Brief Title
A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture
Acronym
Ilobone
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
proximal humeral fracture, proximale Humerusfraktur, Ilomedin, Iloprost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized interventional study with parallel groups. Open labeled, add-on controlled study. In this study, patients will be randomized on a 1:1:1 basis to one of the three arms (two treatment arms and one control arm).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First intervention group (0.125 ng/kg/min Iloprost)
Arm Type
Experimental
Arm Description
The first intervention group will receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.125 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. The catheter will be inserted during the surgical procedure. Infusion of Iloprost will start 24hrs post-operatively and the dose will be delivered over 24h.
Arm Title
Second intervention group (0.25 ng/kg/min Iloprost)
Arm Type
Experimental
Arm Description
The second intervention group will also receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.25 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. Infusion will start 24hrs post-operatively and the dose will be delivered over 24h.
Arm Title
Control intervention group
Arm Type
Other
Arm Description
Control intervention: Patients will receive the standard of care procedure for such fractures, i.e. standard of care open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes).
Intervention Type
Drug
Intervention Name(s)
0.125 ng/kg/min Iloprost
Other Intervention Name(s)
Ilomedin, SUB08136MIG, CAS (Chemical Abstracts Service) number 78919-13-8
Intervention Description
Drug administration through a catheter (inserted at the end of the surgical procedure) begins 24±2 hours after surgery: 0.125 ng/kg/min Iloprost for a duration of 24 hours
Intervention Type
Drug
Intervention Name(s)
0.25 ng/kg/min Iloprost
Other Intervention Name(s)
Ilomedin, SUB08136MIG, CAS number 78919-13-8
Intervention Description
Drug administration through a catheter (inserted at the end of the surgical procedure) begins 24±2 hours after surgery: 0.25 ng/kg/min Iloprost for a duration of 24 hours
Intervention Type
Procedure
Intervention Name(s)
open reduction and internal fixation with an angular stable plate (PHILOS)
Other Intervention Name(s)
humerus surgery, Open Reduction and Internal fixation of proximal humeral fracture using Philos plate, PHILOS Plating
Intervention Description
open reduction and internal fixation with an angular stable plate (PHILOS)
Primary Outcome Measure Information:
Title
Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Description
Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time Frame
12 months
Title
Efficacy analysis using the Tip Apex Distance (TAD) readout
Description
TAD is an indicator of the progress of fracture healing and the probability of potential complications. Thus, it reflects both the safety and efficacy of the investigational treatment. To evaluate the treatment success rate, we will calculate the percentage loss of the summation of TADs of all locking screws. The value will be classified into one of five ranks as measured after 12 weeks of postoperative follow-up compared to the baseline measurement. For the percentage of original Tip Apex Distance, the sum of the Tip Apex Distance of the humeral head screws will be used: Grade 1: 76%-100% preservation of the original distance (representing the best possible result), Grade 2: 51%-75% preservation of the original distance, Grade 3: 26%-50% preservation of the original distance, Grade 4: 0%-25% preservation of the original distance, and Grade 5: if the patient shows signs of screw protrusion (cut out). Grade 1 will be considered as treatment success, grades 2-5 as treatment failure.
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
Rate of humeral head necrosis
Description
Osteonecrosis of the humeral head is a common complication in proximal humerus fracture. (1) The occurrence of osteonecrosis varies significantly according to the grading of the fracture in addition to the initial displacement (valgus or varus), Soft tissue handling during surgical fixation can influence the rate of osteonecrosis (2,3). Both a radiologist and an orthopedic surgeon will confirm the diagnosis of osteonecrosis of the humeral head radiologically at 12th-week and 26th-week visits.
Time Frame
12 weeks and 26 weeks after surgery
Title
Humeral head shaft angle
Description
Humeral head shaft angle is used to plan corrective osteotomies and shoulder arthroplasties as well as to evaluate the postoperative x-ray outcome, as a varus displacement of more than 10 degrees in the X-ray view is considered as loss of fixation (4).
Time Frame
before discharge, 3 weeks, 6 weeks, 12 weeks and 26 weeks after surgery
Title
Pain assessment using the Visual Analogue Scale (VAS)
Description
The VAS instrument consists of a 10 cm long straight line with defined endpoints, ranging from 'no pain' to 'pain as bad as it could be.' The patient will be asked to mark the respective pain level on the line that is felt subjectively. The distance between 'no pain' and the marked pain level determines the patient's pain. Scores are given in mm, ranging from 0-100 (5).
Time Frame
24 hours after surgery, before discharge, 3 weeks, 6 weeks, 12 weeks and 26 weeks after surgery
Title
Quality-of-Life (QoL) by applying EQ-5D
Description
Patients will be asked to answer the questionnaire EuroQol-5 Dimension (EQ-5D), which is a validated instrument determining the quality of life as a health outcome. Developed in Europe, it is widely applied. The tool offers 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (6). The questionnaire includes a visual analog scale where patients can give information on their health state.
Time Frame
3 weeks, 6 weeks, 12 weeks and 26 weeks after surgery
Title
Constant-Murley Score (CMS):
Description
The Constant-Murley Score (CMS) is a 100-points scale composed of different parameters to define the level of pain and the ability of the patient to perform normal daily activities. It is used to determine the functional outcome after treatment of shoulder injuries. The higher the score, the better the function of the shoulder is. CMS is divided into four main subscales: pain (max. 15 points), strength (max. 25 points), daily activity (max. 20 points) and range of motion (40 points). The European Society of Shoulder and Elbow Surgery (ESSE) has promoted the Constant- Murley Score as a gold standard for the assessment of shoulder function (7-9). The Constant-Murley Score takes patient sex and age into consideration. The score can be used relative to age and sex (10).
Time Frame
12 weeks and 26 weeks after surgery
Title
Disabilities of the Arm, Shoulder and Hand score (DASH)
Description
DASH is a 30-item questionnaire that determines the ability of a patient to perform certain upper extremity activities. DASH questionnaire is self-reported, where patients can rate the difficulty and interference with daily life (1 = no difficulty or no symptom, 5 = unable to perform or very severe symptom). Subsequently, a score is calculated using a formula. A DASH score of 0 corresponds to no disability and 100 to extreme disability.
Time Frame
12 weeks and 26 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written informed consent. Adult male or female subjects between 60 to 80 years old at the time of screening visit. Scheduled Proximal Humerus Internal Locking System (PHILOS) with 3 holes plate length for proximal humerus fracture type 3 or 4 according to Neer classification. Patient with American Society of Anesthesiologists (ASA) score of ≤ 2. Single, low energy fracture. Absence of neurovascular complications at the time of trauma. Surgery done within the first 96 hours from injury. Exclusion Criteria: Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship). Immunosuppression due to illness or medication. Subject with malignancy and undergoing treatment including chemotherapy, radiotherapy or immunotherapy. Known allergies to Iloprost. Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers, or intracranial hemorrhage). Severe coronary heart disease or unstable angina; myocardial infarction within the last six months; decompensated cardiac failure if not under close medical supervision; severe arrhythmias; suspected pulmonary congestion; cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months. Acute or chronic congestive heart failure (NYHA II-IV) Pulmonary hypertension due to venous occlusive disease. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. Subject who is currently enrolled in or has not yet completed a period of at least ( a period of time equal to 5 times as the half-life time of the drug used in the previous trial) since ending other investigational device or drug trial(s). Patients who are dependent on the sponsor, investigator or study site. History of previous proximal humerus surgery on the same side. History of proximal humerus deformity on the same side. Pathological or open fracture. Polytrauma patient. Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1). Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel. Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities. Patients with a history of cerebral circulatory disorders. Patients with any symptomatic or treatable heart disease (including stenting), hypertension treated with a β-receptor blocker, calcium agonists, vasodilator or ACE (Angiotensin-converting-enzyme) inhibitor at more than moderate doses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Winkler, Prof.Dr.med
Phone
+49 30 450 559 084
Email
tobias.winkler@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Geissler, Dr. - Ing.
Phone
+49 30 450659539
Email
sven.geissler@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Winkler, Prof. Dr.med
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Muskuloskeletal Surgery, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Winkler, PD Dr.
Phone
+49 30 450 559 084
Email
tobias.winkler@charite.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21968245
Citation
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Results Reference
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23316376
Citation
Khmelnitskaya E, Lamont LE, Taylor SA, Lorich DG, Dines DM, Dines JS. Evaluation and management of proximal humerus fractures. Adv Orthop. 2012;2012:861598. doi: 10.1155/2012/861598. Epub 2012 Dec 18.
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Malavolta EA, Assuncao JH, Pagotto RA, Avelino RL, Gracitelli ME, Pereira CA, Jacomo AL, Ferreira Neto AA. The rotation of the humeral head does not alter radiographic evaluation of the head-shaft angle. J Shoulder Elbow Surg. 2016 Apr;25(4):543-7. doi: 10.1016/j.jse.2015.09.026. Epub 2015 Dec 15.
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Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.
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Hirschmann MT, Wind B, Amsler F, Gross T. Reliability of shoulder abduction strength measure for the Constant-Murley score. Clin Orthop Relat Res. 2010 Jun;468(6):1565-71. doi: 10.1007/s11999-009-1007-3. Epub 2009 Jul 29.
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Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
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Yian EH, Ramappa AJ, Arneberg O, Gerber C. The Constant score in normal shoulders. J Shoulder Elbow Surg. 2005 Mar-Apr;14(2):128-33. doi: 10.1016/j.jse.2004.07.003.
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A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture

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