|- candidate number||13242|
|- NTR Number||NTR3584|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-aug-2012|
|- Secondary IDs||M011-027 METC|
|- Public Title||Results of cast treatment and percutaneous achilles tendon lengthening for children with an achilles tendon contracture.|
|- Scientific Title||A prospective randomized controlled study to evaluate ankle dorsiflexion after cast immobilization and percutaneous gastrocnemius lengthening for children (6-18 years) with an equinus contracture.|
|- ACRONYM||AP study|
|- hypothesis||It is not unusual for children to have an intermittent tiptoe gait when they start to walk. Older children with persistent tiptoe gait in absence of developmental, neurological or neuromuscular conditions, are diagnosed idiopathic toe walkers (ITW's). Most of the time it resolves spontaneously. Sometimes the plantar flexion has a tendency to persist and it's possible a equinus contracture develops with time, eventually with permanent shortening of the gastrocnemius. Further a relationship has been reported between persistent toe walking and the development of ankle equinus and recognition is increasing that a wide variety of pathologies are associated with longstanding equinus contracture. The management of children with ITW is still controversial. To our knowledge, there aren't prospective studies to compare cast and surgical treatment.|
We hypothesized a mean difference of> 5 degrees passive ankle dorsiflexion after treatment with percutaneous gastrocnemius lengthening, compared to ankle dorsiflexion of children after treatment with cast immobilization, after one year follow-up.
|- Healt Condition(s) or Problem(s) studied||Ankle dorsiflexion between -10 and 3 degree, Children|
|- Inclusion criteria||1. Patients (boys and girls) between 6-18 years;|
2. Independent walking achieved;
3. Symptomatic limited dorsalflexion between -10 and 3 grade (with knee in extension and ankle in neutral position and it improves with knee in flexion);
4. Patients has been treated non-surgically for at least 6 month (NSAIDs, stretching, orthoses and physical therapy);
5. Written informed consent both parents/guardian (when patient < 12 year), written informed consent child and both parents/guardian (when child ≥ 12 year).
|- Exclusion criteria||1. Patients with signs of neurological, orthopaedic or psychiatric disease and patients with mental retardation;|
2. Patients with previous surgery on the ankle;
3. Patients with previous treatment of cast immobilization because of equinus contracture;
4. Patients (12 years or older) whose parents are unable to give informed consent;
5. Patients (12 years or older) or parents who are unable to fill out questionnaires;
6. Patients (12 years or older) or parents who are unable to understand treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2018|
|- Target number of participants||78|
|- Interventions||Patients will be treated by percutaneous gastrocnemius lengthening. After surgery patients will be placed in a below-knee cast with also minimal weightbearing for 2 weeks and 4 weeks full weightbearing plaster, followed by physical therapy for 12 weeks.
Control: Patients will be treated by a below knee cast, set in plantigrade, with six weeks full weightbearing plaster, also followed by physical therapy for 12 weeks.
|- Primary outcome||Ankle dorsiflexion.|
|- Secondary outcome||1. Walking pattern;|
5. Activity level by Functional Mobility Scale;
6. AOFAS hindfoot scale: Measures pain functional activity and other complaints;
7. Ground reaction force. Foot pressure measurement (pre- and posttreatment), using the footscanŽ USB plate by RS InternationalŽ. It records the pressure in different parts of the foot during gait. From these readings a pattern of gait is deducted with can be analysed both quantitatively and qualitatively.
|- Timepoints||This study starts at screening on the outpatient clinic (T0) (table 1). Follow-up visits for assessment of primary and secondary endpoints will be scheduled for both treatment groups after two weeks for plaster change (T2). Thereafter follow-up visits will be planned at six weeks (T3), 12 weeks (T4), 6 months (T5), and one (T6) year, after cast immobilization (T1)|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| A.F. Bemmel, van|
|- CONTACT for SCIENTIFIC QUERIES|| A.F. Bemmel, van|
|- Sponsor/Initiator ||Spaarne Hospital|
(Source(s) of Monetary or Material Support)
|wetenschapsbureau Linneus Instituut Spaarne ziekenhuis |
|- Brief summary||Background: |
We present the design of an open randomized study of conservative versus
surgical treatment for children with an equinus contracture. The study is designed to evaluate the difference in dorsiflexion after treatment with cast immobilization versus percutaneous gastrocnemius muscular lengthening for neurologically healthy children (6-18 years) with a symptomatic equinus contracture unresponsive to non-operative care.
80 patients with an equinus contracture will be randomized to percutaneous gastrocnemius muscular 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. Primary end-point will be ankle dorsiflexion. Secondary end-point will be functional outcome, satisfaction, walking pattern, pain, complications, activity level and foot pressure. Patients follow-up will be 1 year.
By making this design study we wish to contribute to more profound research on percutaneous gastrocnemius lengthening for children with an equinus contracture and prevent publication bias for this open-labelled randomized trial.
|- Main changes (audit trail)|
|- RECORD||16-aug-2012 - 8-sep-2012|