Study Stopped
A similar study had already been conducted, therefore pursuing this trial would have been unethical
Botox Clinical Trial
Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The surgery to correct leg \& foot deformities in children is a lengthy, \& 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 \& skin become very tight which causes pain \& 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 \& 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMarch 18, 2015
March 1, 2015
2 years
February 15, 2008
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital
2 years
Secondary Outcomes (1)
Range of movement in affected joints measured by a goniometre
2 years
Study Arms (2)
Botox
EXPERIMENTALBotox
Placebo
PLACEBO COMPARATORSaline injection
Interventions
Eligibility Criteria
You may qualify if:
- Any child with femoral, tibial deformity or CTEV having limb reconstruction surgery which involves the distraction of bone and or soft tissue.
You may not qualify if:
- Children with neurological aetiology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Facility, Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Burton
Sheffield Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 27, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2010
Study Completion
May 1, 2010
Last Updated
March 18, 2015
Record last verified: 2015-03