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

Phase 2

Recruiting

• Conditions: non-traumatic avascular necrosis of the femoral head; M87.0; M87.1; M87.3; M87.8; M87.9; Idiopathic aseptic necrosis of bone; Osteonecrosis due to drugs; Other secondary osteonecrosis; Other osteonecrosis

• Registration Number: DRKS00022404
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. non-traumatic avascular necrosis of the femural head
2. 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 schould be considered for inclusion. (Cases, where both hips are affected may be discussed with the coordinating investigator upfront to trial participation.)
3. Age 18 - 65 years (for patients older than 50 years the differential diagnosis rapidly destructive osteoarthritis must be ruled out)
4. Body weight 50 - 110 kg
5. Written informed consent

Exclusion Criteria

1. patients with N-ANFH of other known aetiology:
a. ongoing chemotherapy or Chemotherapy within the last 12 months
b. ongoing alcohol abuse or alcohol abuse within the last 6 months
c. renal insufficiency
d. kidney transplantation within the last 12 months
e. sickle cell anaemia
f. Gaucher’s dieseas (morbus gaucher)
2. patients who previously underwent core decompression on one side of the hip
3. patients previously treated with iloprost
4. contraindications to Iloprost
5. situations 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)
6. severe coronary heart disease or unstable angina
7. myocardial infarction within the last six months
8. decompensated cardiac failure if not under close medical supervision
9. Severe arrhythmias
10. Suspected pulmonary congestion
11. Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last three months
12. acute or chronic congestive heart failure staged NYHA II-IV
13. pulmonary hypertension due to venous occlusive disease
14. congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
15. liver cirrhosis
16. infection with SARS-2-CoV requiring hospitalisation in the last seven weeks prior to core decompression
17. known vascular aneurysm
18. fertile women without appropriate contraceptive measures
19. previous participation in the ILONA trial
20. participation in other interventional trials
21. patients under legal supervision or guardianship
22. physiological, psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ...)
23. suspected lack of compliance
24. pregnant or nursing women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint it the result of the Harris Hip Score (HHS) after 12 months. This score will be evaluated at baseline, at discharge from the hospital and after 3, 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
- Time to total hip arthroplasty (THA) in the time period until 12 months after randomisation<br>- MRI confirmed subchondral fracture after 3 and 12 months<br>- Appearance of MRI-confirmed bone marrow oedema (BME) and / or necrosis after 3 and 12 months.<br>- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) at discharge, after 3, 6 and 12 months<br>- SF-36 at discharge, after 3, 6 and 12 months<br>