Core decompression versus core decompression followed by infusion of Iloprost in thetreatment of idiopathic non-traumatic avascular necrosis of the femoral head

Phase 1

• Conditions: idiopathic non-traumatic avascular necrosis of the femoral head (IN-ANFH); MedDRA version: 21.1Level: LLTClassification code 10003860Term: Avascular necrosis femoral headSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-000624-20-DE
• Lead Sponsor: eipzig University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-26
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1.Idiopathic non-traumatic avascular necrosis of the femural head
2.Core Lab evaluation: ARCO stage I or II diagnosed and confirmed by:
a.X-ray of both sides of the hip (Pelvis overview and both sides of the hip in Lauenstein position)
AND
b.MRI of both sides of the hip
Note: In patients where both hips are affected, the clinically more severely affected hip will be considered for inclusion.
3.Age 18 - 50 years (maximum of 50 years is defined to prevent confusion with rapidly destructive osteoarthritis)
4. body weight 50 - 110 kg
5.Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Patients with N-ANFH of other known aetiology
a.Ongoing systemic cortisol therapy or local treatment at the hip joint or
b.Chemotherapy or
c.Alcohol abuse (anamnestic assessment) or
d.Renal insufficiency [GFR <50ml/min/1,73m2 (compensated renal insufficiency) or <60ml for the duration of more than three months]
e.Kidney transplantation
f.Rheumatism
g.Sickle cell anaemia
h.Gaucher’s dieseas (Morbus Gaucher)
i.Caisson disease
j.Systemic lupus erythematosus

2.Patients with multiple osteonecrosis
3.Patients who previously underwent core decompression on one side of the hip
4.Patients previously treated with Iloprost
5.Contraindications to Iloprost such as hypersensitivity to Iloprost or its excipients (Trometamol, Ethanol 96%, sodium chloride, hydrochloric acid)
6.Situations or parallel treatment in which the effect of the drug on the platelets could increase the risk of bleeding complications (e.g. active peptic ulcer, trauma, intracranial hemorrhage, treatment with NSAR in the last 4 days (or longer until the 5-fold half-life is reached)
7.Severe coronary heart disease or unstable angina
8.Myocardial infarction within the last six months
9.Decompensated cardiac failure if not under close medical supervision
10.Severe arrhythmias
11.Suspected pulmonary congestion
12.Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last three months
13.Acute or chronic congestive heart failure staged NYHA II-IV
14.Pulmonary hypertension due to venous occlusive disease
15.Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
16.Liver cirrhosis
17.Infection with SARS-2-CoV requiring hospitalisation in the last seven weeks prior to core decompression
18.Known vascular aneurysm
19. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception).
20.Previous participation in the ILONA trial
21.Participation in other interventional trials
22.Patients under legal supervision or guardianship
23.Physiological, psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ...).
24.Suspected lack of compliance
25.Pregnant or nursing women (negative pregnancy test is required)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified