FermaTrial: a study on the treatment of osteoarthritis by means of injections in the hip joint.

Conditions: ArthrosisHip

Registration Number: NL-OMON24527

Lead Sponsor: Maatschap Orthopedie, Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

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
Differences in pain reduction between patients with osteoarthritis of the hip treated with intra-articular injections with Fermathron S (hyaluronic acid) and patients treated with corticosteroids (Depomedrol).

Secondary Outcome Measures

Name	Time	Method
1. Differences in function and radiological changes between the group treated with Fermathron S and the group treated with Depomedrol.<br>2. Safety of Fermathron S in patients with osteoarhritis of the hip.<br>3. Differences in paracetamol consumption between the group treated with Fermathron S and the group treated with Depomedrol.