Botulinum toxin: an adjunct in limb reconstruction - Can it reduce pain and joint complications in the lengthening phase?
Not Applicable
- Conditions
- imb reconstruction surgerySurgeryLimb reconstruction surgery
- Registration Number
- ISRCTN35609758
- Lead Sponsor
- Sheffield Children's NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Any child having reconstruction surgery which involves the distraction of bone and or soft tissue for femoral or tibial deformity and congenital talipes equinovarus.
2. Children between the ages of 6 and 18 years attending the Sheffield Children's NHS Trust
Exclusion Criteria
Children with neurological aetiology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain levels using a visual analogue scale validated at the Sheffield Children's Hospital. Following discharge from hospital, patients will be asked to continue recording pain level three times a day for 18 month or until discharged i.e. end of episode, which ever is first.
- Secondary Outcome Measures
Name Time Method <br> 1. Range of movement in affected joints measured by a goniometre, recorded at each clinic visit until one month from the end of lengthening<br> 2. Walking measured using a pedometer, recorded at each clinic visit until one month from the end of lengthening<br> 3. Scores of the Child Health Questionnaire and the Pediatric Outcome Data Collection Instrument, administered pre-operatively, one month post-lengthening completion and one year from surgery<br>