To prove superiority of Fermathron plus in the treatment of patients with mild knee OA compared to placebo
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Pain in the affected knee
2. Restricions in daily activities due to the affected knee
Secondary outcome
1. Patient satisfaction with the applied treatment
2. Safety of the applied treatment.
3. Range of motion in the affected knee
Background summary
The department of orthopedic surgery of the St. Anna hospital started in 2006
with intra-articulair injecting of hyaluronic acid (Fermathron) as the standard
treatment for patients with mild osteoarthritis of the knee. So far, the
Knowledge Centre for Orthopedic Surgery has carried out a prospective
registration study of all patients treated with hyaluronic acid within this
hospital. Analys of this data indicates that Fermathron is safe and possibly
effective in the treatment of mild knee OA. To gather more evidence on the
effectiveness and safety of these hyaluronic acid injections, this double
blind, placebo-controlled study is designed. This study will compare Fermathron
plus with respect to clinical outcomes and safety to a placebo-treatment. This
will provide evidence for the present treatment of patients with mild knee OA
in our orthopedic department and collegues can be informed with presentations.
Study objective
To prove superiority of Fermathron plus in the treatment of patients with mild
knee OA compared to placebo
Study design
This study is designed as a double blind, placebo-controlled study. Patients
are randomised to either a treatment group (3 injections with Fermathron plus)
or the placebo-group (3 injections with saline). Follow up consists of 4 follow
up moments, the last one 6 months after the last injection.
Intervention
Included patients are randomised to either the treatment group (3 injections
with Fermathron plus) or to the placebo group (3 injections with saline)
Study burden and risks
The HA in Fermathron plus is derived from a naturally occurring bacterium,
which is not pathogenic in man, and there is no risk of transfer of animal
viruses. The risk from bacterial antigens is minimized by the manufacturing
process of continuous fermentation (in which there is minimal breakdown of cell
components) together with rigorous purification. The sodium hyaluronate is
produced as a capsule around the outside of the cell so that the cell does not
have to be disrupted to release the product. The purification of the sodium
hyaluronate has been optimized during manufacturing and is closely monitored to
ensure the consistent removal of potential antigenic impurities. Previous
clinical studies have shown that intra-articular injection of HA is very well
tolerated and any adverse events related to the treatment are local and
transient. To minimize the risk of any adverse effects associated with the
procedure, all the investigators taking part in the study are experienced in
the technique. Injections will be given with a lateral approach to a straight
knee, this having a lower risk of adverse effects than other methods. Data from
our own prospective group show that 5% of all treated
Postbus 90
5660 AB
NL
Postbus 90
5660 AB
NL
Listed location countries
Age
Inclusion criteria
Mild osteoarthritis of the knee, Kellgren-Lawrence grade I-III
Exclusion criteria
Bilateral osteoarthritis of the knee
Pregnancy
Lactation
Infection of the knee
evidence of skin disease
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 |
|---|---|
| CCMO | NL19495.015.07 |