To indentify the surgical intervention with the best result in case of a rigid claw toe.
ID
Source
Brief title
Condition
- Joint 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 foot
Physical examination
Satisfaction scale
Nijmegen classification
Cosmetic scale
Mobility scale
Background summary
The incidence of symptomatic lesser toe deformities, like claw toes, in the
literature ranges from 2 to 20%. Interventions of lesser toe deformities are
among the most performed procedures in general orthopaedic pratice.There is a
variation in surgical methods to correct claw toes.
It is striking there is no international consensus in the treatment of a claw
toe deformity. A prospective study will need to correct indistinctnesses and to
result in standardized guidelines in the treatment of these deformities.
Study objective
To indentify the surgical intervention with the best result in case of a rigid
claw toe.
Study design
A prospective randomised multi centre study will be conducted. The patient
needs to sign the informed consent before randomisation. After randomising
every patient will be designated to one of the two methods of surgery. The two
methods will be: a PIP- resection arthroplasty or a PIP- arthrodesis. In both
study groups the MTP joint will be corrected by means of "soft tissue release".
All patients, who meet the inclusion criteria as described below, with (a)
symptomatic rigid claw toe(s) and an indication for surgery, will be randomised
for one of the two surgical methods. After information and signing the
"informed consent" form the patients will be included in the study.
Intervention
Surgery; one of the two methods:
1. PIP- resection arthroplasty
2. PIP- arthrodesis
If necessary: correction of hallux valgus.
Study burden and risks
Every outpatient visit of the included patient will have a duration of about
60 minutes. Then a X- ray of the foot will be performed, the patient will be
interviewed, physical examination will be performed and the patient will have
to fill out specific questionnaires. 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
One or multiple claw toe deformities
A rigid deformity
Age 20-85 yrs
Exclusion criteria
*Surgical intervention of toe(s), performed prior to study procedure
*Simultaneous intervention of the foot, except for toe surgery
*Comorbidity: arterial insufficiency, complex regional pain syndrom (CRPS), diabetes mellitus, neuropathy
*Underlying diseases which need to be treated before study procedure (i.e. cavus foot, ulcera)
*Generalized joint diseases (i.e. reumathoid arthritis)
*Impaired mobility as result of other pathology (hemiplegia, situation after aputation)
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 | NL15432.075.06 |