To identify if soft tissue correction of the MTP joints compared to resection of the metatarsal heads (Hoffman's procedure), in patients suffering from reumatoid arthritis, has better outcome; in both study groups PIP resection artroplasty and…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Kitaoka foot/ ankle score (=AOFAS score)
Secondary outcome
VAS pain score
X- ray of the foot
Physical examination
Satisfaction scale
Nijmegen classification
Cosmetic scale
Mobility scale
Background summary
Almost 90% of the patients, suffering from reumatoid arthritis, has symptoms
of foot deformities. Most of the times there is a combination of hallux valgus
with progressive dorsal subluxation of the lesser MTP joints.
In case of MTP deformities in patients with reumatoid arthritis there is not
always uniformity in which surgical procedure to apply. One may choose between
resection of the metatarsal heads (Hoffman procedure) and soft tissue
correction.
In the literature there are no prospective randomized studies about lesser toe
surgery in patients suffering from reumatoid arthritis. A prospective study
needs to correct indistinctnesses and needs to result in an empirical basis for
the intervention of first choice in specific arthritic deformities.
Study objective
To identify if soft tissue correction of the MTP joints compared to resection
of the metatarsal heads (Hoffman's procedure), in patients suffering from
reumatoid arthritis, has better outcome; in both study groups PIP resection
artroplasty and MTP 1 arthrodesis will be performed during the same operation.
Study design
It is a prospective randomised multi-centre clinical study. In every medical
centre each patient will be randomised for one of the operative procedures
(Hoffman procedure vs soft tissue release). This will lead to two study groups,
which will be compared.
Indications for surgery are: reumatoid arthritis, pain, impaired mobility,
dislocation and destructive changes of the MTP joints and after failure of
conservative therapy after a duration of at least 6 months of therapy. After
information and signing the informed consent form the patient will be included
in the study.
Intervention
Surgery; one of the two methods:
1. Resection of the metatarsal heads (Hoffman's procedure)
2. Soft tissue release of MTP joints
Study burden and risks
The postoperative follow- up moments are at 3 months, 1 year and 5 year. Every
outpatient visit of the included patient will have a duration of about 60
minutes. During these visits the patient will be interviewed, physically
examined and the patient will have to fill out certain questionnaires. At 1 and
5 year postoperatively a X- ray of the foot will be performed. Next to these
visits there will not be any other burden for the patient, related to this
study.
Except for the known risks related to surgery, there are no extra risks
related to this study.
Groot Wezenland 20
8011 JW
NL
Groot Wezenland 20
8011 JW
NL
Listed location countries
Age
Inclusion criteria
Every cooperative patient with reumathoid arthritis, who has an indication for surgical intervention because of symptomatic MTP deformities (as defined in the protocol).
Exclusion criteria
*Infected bursae/ clavi
*Active reumathoid arthritis
*Simultaneous surgical intervention of the foot, except for toe surgery
*Certain comorbidity: arterial insufficiency, complex regional pain syndrome, diabetes mellitus, active infection
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 | NL15511.075.06 |