Will the hyaluronic acid injections have impact on pain reduction and functional improvement in patients with osteoarthritis of the hip ?
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary purpose of the study is to determine differences in pain reduction
between patients with osteoarthritis of the hip treated with intraarticular
injections with Fermathron S (hyaluronic acid) and patients treated with
Depomedrol (corticosteroids) at 6 and 12 months follow-up.
Secondary outcome
Secondary parameters
- Differences in function and radiological changes after treatment with
Fermathron S will be evaluated by function score forms, questionnaires and
x-rays).
-Is Fermathron S a safe product in patients with osteoarthritis of the hip ?
- Is there a difference in paracetamol consumption between the group treated
with Fermathon S and the group treated with Depomedrol?
Background summary
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 objective
Will the hyaluronic acid injections have impact on pain reduction and
functional improvement in patients with osteoarthritis of the hip ?
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.
Study burden and risks
X-ray radiation during injection. Injection itself can be experienced as
painful, with a very small chance of infection.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001200-22-NL |
| CCMO | NL44152.099.13 |
| Other | volgt |
| OMON | NL-OMON24527 |