Will the hyaluronan acid injections have impact on painreduction en functional improvement?
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 the difference in pain
reduction and functional recovery between the researchgroups.
Secondary outcome
1 and 2 years after randomization, an assessment will be carried out in which
the percentage of patients in each group that recieved a THP is calculated.
In addition, radiological progression during outpatient visits evaluated by
X-ray (every half year) will be assessed.
A possible effect of hyaluronic acid in negafief recent exacerbation of
arthritis is analyzed.
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 hyaluronan acid.
However the long term effects are unknown.
Study objective
Will the hyaluronan acid injections have impact on painreduction en functional
improvement?
Study design
Multi centre randomised, blinded and prospective trail. consisting three
groups; (I) Hyaluronan acid (HA), (II) Corticosteriods and (III) Control group.
Intervention
Group I will recieve 2ml hyaluronan acids and 3ml lidocaine. Group II will
reciece 2ml corticosteriods and 5ml lidocaine. Group III will recieve 5 ml
Lidociane. This every 3 months.
Study burden and risks
X-ray radiation during injections. Injection itself can be experienced as
painful, with a very small chance of infection.
H. Dunantweg 2
8934 AD Leeuwarden
NL
H. Dunantweg 2
8934 AD Leeuwarden
NL
Listed location countries
Age
Inclusion criteria
above 18 years-old
symptomatic coxarthrosis
signed informed consent
Exclusion criteria
bad health
ipsilateral gonarthritis
clinical significant neurovascular disease
former surgical procedures of the hip
osteonecrosis, osteomyelitis of the hip
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-022106-40-NL |
| CCMO | NL29912.099.10 |