To investigate the difference in muscle-tendon parameters of 2-11 years old unilateral clubfoot patients by means of 3D ultrasound. Subaims investigate the relation between muscle-tendon properties and age/ functional/clinical status of the clubfoot…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(difference in) calf-muscle volume
Secondary outcome
secondary muscle-tendon properties such as pennation angle, fiber length and
muscle and tendon cross-sectional area
functional status of the clubfoot according to the Clubfoot Assessment Protocol
clinical status (relapse)
age
Background summary
Congenital equinovarus talipes, also called clubfoot, is a common congenital
disorder occurring in 1.09 - 1.52 per 1000 new-borns. Although the name
*clubfoot* implies that it is a disorder of the foot, actually the whole lower
extremity including its ligaments, bones, muscles, and tendons are affected in
clubfoot. Muscle atrophy of the affected leg in unilateral clubfoot patients
seems to increase with age. However previous studies are based on MRI images of
a heterogenic small sample of clubfoot patients. Furthermore, these studies did
not investigate the muscle-tendon development in clubfoot patients during the
last phase of Ponseti treatment and immediately after Ponseti treatment. This
phase is especially of interest in relation to change in treatment (with and
without brace), the development of a relapse and functional status of the rapid
growing foot.
Study objective
To investigate the difference in muscle-tendon parameters of 2-11 years old
unilateral clubfoot patients by means of 3D ultrasound. Subaims investigate the
relation between muscle-tendon properties and age/ functional/clinical status
of the clubfoot patient.
This information will give insights related to timing and content of possible
additional treatment.
Study design
Observational study
Study burden and risks
Participating in the study will not result in a direct advantage for the
children and/or their parents. It is expected that patients and parents
experience no hindrance or risk from this study, except for the half-hour time
investment. Measurements will be combined with a regular out-patient visit at
the Máxima MC. Additional imaging (X-ray, MRI, ultrasound) and administration
of the Clubfoot Assessment Protocol is common practice in the follow up of
clubfoot patients. As compensation for their participation in the study, the
children will receive a small gift at the end of the measurement (e.g., sticker
sheet).
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
- Idiopathic clubfoot patients
- Unilaterally affected
- 2 t/m 11 years old
- Primarily treated with the Ponseti method
- Relapse group: planned for relapse treatment (e.g. but not limited to
tibialis anterior transposition / hemi-epiphysiodesis)
Exclusion criteria
- Patients with underlying syndromes
- Bilaterally affected patients
- Patients who had primary treatment for their clubfoot other than the Ponseti
method
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 |
|---|---|
| Other | is in aanvraag (reactie in overleg met Y de Haan) |
| CCMO | NL84721.015.23 |