By making this design study we wish to contribute to profound research on percutaneous gastrocnemius lengthening for for children with an equinus contracture and prevent publication bias for this open-labelled randomized trial.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end-point will be ankle dorsiflexion.
Secondary outcome
Secondary end-point will be satisfaction, walking pattern, pain, complications,
activity level and foot pressure. Functional outcome will be measured by:
AOFAS-score and functional mobility scale (FMS).
Background summary
We present the design of an open randomized study on conservative versus
surgical treatment of children with an equinus contracture. The study is
designed to evaluate the difference ankle dorsiflexion after cast
immobilisation versus percutaneous gastrocnemius lengthening for Neurology
healthy children (6-18) with an equinus contracture where zonservative
treatment had been failed.
Study objective
By making this design study we wish to contribute to profound research on
percutaneous gastrocnemius lengthening for for children with an equinus
contracture and prevent publication bias for this open-labelled randomized
trial.
Study design
Prospective randomised controlled study.
Patients will be randomized to percutaneous gastrocnemius lengthening followed
by a below knee cast for 6 weeks and intensive physical therapy for 12 weeks or
no surgery but a below knee cast for 6 weeks also followed by physical therapy
for 12 weeks. Both treatment arms use a 18 weeks protocol. After 18 weeks the
patient will have physical therapy low intensive (once per 4 weeks) until one
year after the study starts.
Intervention
percutaneous gastrocnemius lengthening
Study burden and risks
To our knowledge there are no potential risks for the included patients.
Percutaneous gastrocnemius lengthening has a little chance of general surgical
complications like: woundinfection, thrombosis, bleeding or nerve damage. Cast
immobilisation has a chance of thrombosis or presur ulcus.
Spaarnepoort 1
2134 TM Hoofddorp
NL
Spaarnepoort 1
2134 TM Hoofddorp
NL
Listed location countries
Age
Inclusion criteria
Patients (boys and girls) between 6-18 years
independent walking achieved
symptomatic limited ankle dorsi flexion between -10 and 3 degrees (with knee in extension and ankle in neutral position)
patient has been treated non-surgically for at least 6 month (NSAIDs, stretching, orthoses and physical therapy)
Written informed consent both parents/ guardian (children 6-12 years)
written informed consent both parents/ guardian and child (children 12-18 years)
Exclusion criteria
Patients with signs of neurological, orthopaedic or psychiatric disease.
Patients with mental retardation
Patients with previous surgery on the ankle
Patients who were already treated with castimmobilisation because of equinus contracture
Patients (12 years or older) whose parents are unable to understand informed consent
Patients (12 years or older) or parents who are unable to fill out questionnaires
Patients (12 years or older) or parents who are unable to understand treatment
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 | NL33762.094.10 |