The positive short term effects of intra-articular injections with corticosteroids and hyaluronic acid are known. However, the longterm effects are unknown.
ID
Bron
Verkorte titel
Aandoening
Arthrosis
Hip
Ondersteuning
Hyaltech provides the hyaluronic acid
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The positive short term effects of intra-articular injections with corticosteroids and hyaluronic acid are known. However, the longterm effects are unknown.
Onderzoeksopzet
At 6 and 12 months follow-up
Onderzoeksproduct en/of interventie
Group I: 3 ml hyaluronic acid and 2 ml lidocaine
Group II: 2 ml corticosteroids and 3 ml lidocaine
Publiek
8934 AD Leeuwarden
The Netherlands
P.C. Rijk
Leeuwarden 8934 AD
The Netherlands
+(0)58-2867666
Wetenschappelijk
8934 AD Leeuwarden
The Netherlands
P.C. Rijk
Leeuwarden 8934 AD
The Netherlands
+(0)58-2867666
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 18 years or older
2. Symptomatic coxarthritis
3. Baseline hip pain VAS score of 15 mm or more
4. Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4228 |
| NTR-old | NTR4373 |
| CCMO | NL44152.099.13 |
| OMON | NL-OMON40597 |