Condition category
Surgery
Date applied
18/02/2008
Date assigned
19/02/2008
Last edited
05/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr James A Fernandes

ORCID ID

Contact details

Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCH-07-006; Sponsor ref: 7860

Study information

Scientific title

Acronym

Botox

Study hypothesis

The surgery to correct leg and foot deformities in children is a lengthy, and sometimes, difficult procedure. Metal frames are attached to the leg and/or foot and over a period of time the frame is manipulated to obtain the corrected position. During this period the muscles and skin become very tight which causes pain and may pull the joint out of position. When this happens it is sometimes necessary to stop the treatment before the best position is obtained. This means that not only is the child left with an inadequate result but that further surgery is required in the future. If the tension could be removed whilst the treatment is underway this would reduce the pain, the possibility of joint damage and potentially allow a more satisfactory to be obtained without the need for further surgery.

Botulinum toxin or Botox®, as it is commonly called, has the potential to temporarily reduce the tension in the muscles without causing permanent damage.

Ethics approval

An application has been submitted to the North Sheffield Research Ethics Office. Approval pending as of 18/02/2008.

Study design

Patient/assessor-blinded, pilot, randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Limb reconstruction surgery

Intervention

Trail status amended to 'stopped' as of 05/04/2013 due to notification that the study was withdrawn.

Patients and the researcher collecting data will be blinded to the allocation of treatment.

Intervention group: Botulinum toxin intramuscular injections, 4 units per kg body weight
Control group: Saline injections

Intervention type

Drug

Phase

Not Specified

Drug names

Botulinum toxin (Botox®)

Primary outcome measures

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

1. Range of movement in affected joints measured by a goniometre, recorded at each clinic visit until one month from the end of lengthening
2. Walking measured using a pedometer, recorded at each clinic visit until one month from the end of lengthening
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

Overall trial start date

01/04/2008

Overall trial end date

01/04/2010

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36

Participant exclusion criteria

Children with neurological aetiology

Recruitment start date

01/04/2008

Recruitment end date

01/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Sheffield Children's NHS Foundation Trust (UK)

Sponsor details

c/o Mrs Vee Mapunde
Clinical Research Facility
D Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2267846
vee.mapunde@sch.nhs.uk

Sponsor type

Government

Website

http://www.sheffieldchildrenscrf.nhs.uk

Funders

Funder type

Charity

Funder name

Sheffield Hospitals NHS Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes