Part one: To quantify the influence of weightbearing on the IMA, HVA and DMAA, measured according the actual gold standard of measurement.Part two: Validation of the Dutch version of the Foot Ankle Outcome Score (FAOS) and the Dutch version of the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For part one: Influence of weightbearing on IMA, HVA and DMAA in patients with
hallux valgus deformity.
For part two: Validation of the Dutch version of the FAOS and MOXFQ for first
ray deformity.
Secondary outcome
Intra- en interobserver variation for angular measurements of first ray
deformity.
Background summary
Angular measurement is an important tool for the choice of treatment of hallux
valgus deformity. Literature has suggested treatment flow charts for treatment
depending of the intermetatarsal (IMA), hallux valgus (HVA) and distal
metatarsal articular angles (DMAA). In orthopedic surgery both weightbearing
and non-weightbearing foot radiographs are used for measurement of these
angles. Little is known about the influence of weightbearing on these specific
angles.
Patient outcome and satisfaction questionnaires are increasingly popular in
modern medical and surgical follow up. Unfortunately, for forefoot problems no
Dutch validated questionnaires is available.
Study objective
Part one: To quantify the influence of weightbearing on the IMA, HVA and DMAA,
measured according the actual gold standard of measurement.
Part two: Validation of the Dutch version of the Foot Ankle Outcome Score
(FAOS) and the Dutch version of the Manchester-Oxford Foot Questionnaire
(MOXFQ) for patients with first ray deformity.
Study design
The study will comprise two parts. Patients will be included according to the
GCP principle. For part one, patients will undergo a physical examination and 4
radiographs will be made of each foot. (Antero-Posterior (AP) weightbearing and
non-weightbearing & Lateral (LAT) weightbearing and non-weightbearing). Angular
measurements will be performed according to the gold standard. For part two,
only the patients with first ray deformity will be asked to complete a set of
questionnaires, including the Dutch version of the FAOS, MOXFQ, SF-36 and VAS
pain and limitation. Two weeks later patients will receive a new set of
questionnaires to complete at home and to return to the orthopedic department.
Study burden and risks
Each extremity radiograph (e.g. foot) exposes the patient to <0.01mSv. This
means that included patients will receive <0.02mSv extra per foot. This amount
is negligible compared to the yearly background radiation at sea level (2-3
mSv). According to the guidelines of the ICRP occasional diagnostic radiography
of the extremity is highly unlikely to cause malignancy.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
- Patient with uni- or bilateral hallux valgus deformity
- Patient with forefoot disability, other than hallux valgus deformity
- Male or non-pregnant female aged 18-90
- Patients who signed the Ethics Committee approved specific Informed Consent Form
Exclusion criteria
- Earlier foot surgery
- Earlier fracture of any bone of the foot, with exception for phalanx of digitus II-V fracture
- Cerebral palsy
- Rheumatoid arthritis
- Not motivated for inclusion
- Dutch language not mastered
- Pregnant patients
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL37757.098.11 |