Intraarticular treatment of osteoarthrits of the hip: A randomized trial of hyaluronic acid (Fermathron S) vs corticosteroids (Depomedrol).

Phase 4

Withdrawn

Conditions: arthritis of the hip
coxarthritis
10023213

Registration Number: NL-OMON40597

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 188

Inclusion Criteria

1. Age 18 years or older
2. Symptomatic coxarthritis
3. Baseline hip pain VAS score of 15 mm or more
4. Signed informed consent

Exclusion Criteria

1. Ipsilateral gonarthritis
2. Clinical significant neurologic or vascular disease
3. Previous intra-articular injections in the affected hip
4. Osteonecrosis or osteomyelitis of the affected hip
5. Rheumatoid arthritis or other inflammatory arthrides
6. Previous surgical procedures of the hip
7. Active or suspected infection in or around the hip
8. Limitation to give an intra-articular injection in the affected hip
9. Current treatement with corticisteroids for another disease
10. Serious liver or kidney failure
11. An alcohol or drug addiction
12. Pregnancy or breastfeeding
13. Contraindications to components of Fermatron, Depomedrol or lidocaine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary purpose of the study is to determine differences in pain reduction<br /><br>between patients with osteoarthritis of the hip treated with intraarticular<br /><br>injections with Fermathron S (hyaluronic acid) and patients treated with<br /><br>Depomedrol (corticosteroids) at 6 and 12 months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters<br /><br><br /><br>- Differences in function and radiological changes after treatment with<br /><br>Fermathron S will be evaluated by function score forms, questionnaires and<br /><br>x-rays).<br /><br><br /><br>-Is Fermathron S a safe product in patients with osteoarthritis of the hip ?<br /><br><br /><br>- Is there a difference in paracetamol consumption between the group treated<br /><br>with Fermathon S and the group treated with Depomedrol?</p><br>