No registrations found.
ID
Source
Brief title
Health condition
Arthrosis
Hip
Sponsors and support
Hyaltech provides the hyaluronic acid
Intervention
Outcome measures
Primary outcome
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
1. Differences in function and radiological changes between the group treated with Fermathron S and the group treated with Depomedrol.
2. Safety of Fermathron S in patients with osteoarhritis of the hip.
3. Differences in paracetamol consumption between the group treated with Fermathron S and the group treated with Depomedrol.
Background summary
Background of the study:
Conservative treatment concerning coxarthosis has been limited to pain medication and physical therapy. Also known are the positive short term effects of intra-articular injections with corticosteriods and hyaluronic acid. However, the long term effects are unknown.
Study design:
Multi centre randomised, blinded and prospective trial consisting of two groups; (I) Hyaluronic acid (Fermathron S) and (II) Corticosteriods (Depomedrol).
Intervention:
Group I will recieve 3 ml hyaluronic acid and 2 ml Lidocaine. Group II will receive 2 ml corticosteriods and 3 ml Lidocaine.
Primary outcome:
To determine 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 Depomedrol (corticosteroids) at 6 and 12 months follow-up.
Study objective
The positive short term effects of intra-articular injections with corticosteroids and hyaluronic acid are known. However, the longterm effects are unknown.
Study design
At 6 and 12 months follow-up
Intervention
Group I: 3 ml hyaluronic acid and 2 ml lidocaine
Group II: 2 ml corticosteroids and 3 ml lidocaine
8934 AD Leeuwarden
The Netherlands
P.C. Rijk
Leeuwarden 8934 AD
The Netherlands
+(0)58-2867666
8934 AD Leeuwarden
The Netherlands
P.C. Rijk
Leeuwarden 8934 AD
The Netherlands
+(0)58-2867666
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4228 |
| NTR-old | NTR4373 |
| CCMO | NL44152.099.13 |
| OMON | NL-OMON40597 |