The aim of this study is to investigate the efficacy, accuracy and patient satisfaction of intra-articular injections in the osteo-arthritic ankle joint using the traction device compared to the conventional method of injecting.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Failure rate of the different injection procedures
Secondary outcome
To investigate the effect of traction on the joint space.
To compare patient satisfaction of the injection technique with and without the
traction-device.
To compare the practical value of the injection technique with and without the
traction-device.
Background summary
Study Rationale
The conventional injection method for injecting the intra-articular joint has
a lot of adverse events, most likely injection related, a percentage of 2-47%
has been found for the knee joint. 12-15. It has been proved that only 67% of
injections in the ankle joint is intra-articular.23
To improve the chance of injecting the ankle intra-articular, a new method was
designed and is currently used on our daycare centre.
However this method has not been proved yet, despite the fact that both surgeon
and patient seem to be satisfied.
This new method uses a traction device with which we hope to open up the joint
to allow easier access with the needle, in literature it has been proved that
with the aid of a traction device the joint will open. However this was tested
on healthy volunteers and on patients under anesthesia with no or just mild
osteo-arthritis. Hyaluronic acid injections are used on patients with varying
grades of osteo-arthritis. Osteo-arthritis stiffens the movement of the ankle
and osteophytes block the way of the needle.
Therefore this is a much more difficult group to inject intra-articular. The
exact dose of hyaluronic acid which the patients need to get an optimal pain
relieve has not yet been sustained. Hyaluronic acid needs to be injected
intra-articular for an optimum of pain relieve.
We performed a dose finding pilot study, which has not been published yet.
The results of this study however show a discrete tendency to use more than one
injection to get more pain relief.
Study objective
The aim of this study is to investigate the efficacy, accuracy and patient
satisfaction of intra-articular injections in the osteo-arthritic ankle joint
using the traction device compared to the conventional method of injecting.
Study design
A cross-over pilot study in which two injection techniques in the ankle joint
will be compared.
Study burden and risks
This investigation uses X-ray to control the placement of the needle with the
help of contrast.
The first group of patients (10)who will be injected with the aid of the
tractiondevice will also get a measurement of their joint space, with and
without the use oftraction.
We will use the rotating C-bow to make a 3D reconstruction before and after
traction. to measure the gain in jointspace.
Patients who are allergic to contrast will be excluded.
Follow up will take place one week after each injection, in the case of an
adverse event weekly contact will take place untill the event has been.
After each injection patients will be asked to give a VAS score for the pain
during injection, after two injections they will be asked,which method they
prefered.
Meibergdreef 9
1100DD Amsterdam
Nederland
Meibergdreef 9
1100DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
male or female aged 18 years or older
osteoarthritis of the ankle joint confirmed by X-rays
candidate for hyaluronic acid
informed consent
Exclusion criteria
Known allergic reaction to contrast
Pregnancy or nursing
oral or parenteral anticoagulant therapy
Design
Recruitment
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 | NL12536.018.06 |