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Sponsored by: |
Sheffield Children's NHS Foundation Trust |
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Information provided by: | Sheffield Children's NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00624299 |
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.
Condition | Intervention | Phase |
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Leg Length Inequality Foot Deformities |
Drug: Botox Other: Saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase? |
Estimated Enrollment: | 36 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Botox: Experimental
Botox
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Drug: Botox
Botox injection (100 ius) per muscle
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Placebo: Placebo Comparator
Saline injection
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Other: Saline
Saline injection
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Excessive soft tissue tension (i.e.. tight muscles and associated tissues) is the most limiting factor in lengthening and correction of limb length deficiency. Bone lengthening is achieved by surgically breaking the bone and with the use of an extending device, commonly placed on the outside of the limb, the bones ends are distracted. One millimetre a day is commonly the amount of distraction, however the soft tissue increases in length at a slower pace than the bone which leads to soft tissue tension.
Excessive soft tissue tension leads to:
Increasing pain levels accompany these deformities leading to a greater reluctance to comply with treatment or rehabilitation. The lack of joint mobility has further detrimental effect on the limb as it becomes weak and stiff.
These events become a vicious cycle which is difficult to resolve without further intervention. When soft tissue tension is becoming a problem, i.e. pain levels are increasing and difficult to control, or the joint is under threat of instability, the first course of action is to slow or stop the lengthening for a few days which allows the soft tissue tension to decrease. The drawback with this is the potential for the bone ends to start fusing and prevent further lengthening once the process is resumed. To re start the process means the child has to have a further general anaesthetic to enable the bone to be re osteotomised (re broken).
Online Form 6 Some groups of children who undergo lengthening are more susceptible to soft tissue tension than others and therefore prophylactic surgical measures are employed. In anticipation of the soft tissue tension muscles known to create problems are commonly selected for surgical releases. This has been shown to be an effective method for reducing the effects of the tension but it is not without its problems. Releases done at the time of surgery may heal before the lengthening is complete and may need to be repeated. Releases cause trauma to the muscle or tendon which then heals by scar tissue, a structure known to be less pliable than specialised muscle or tendon tissue. Regaining long term function can be compromised.
Temporarily reducing soft tissue tension during the lengthening phase of treatment which has no long term consequences would be an ideal situation. Botulinum toxin has the ability to do this. Paley (2004) used Botulinum toxin as an adjunct to or in place of soft tissue release during femoral lengthening and noted that it seemed to reduce muscle spasm and pain in patients. Unfortunately this was not supported by any form of evaluative research.
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James A Fernandes | 0114 2717000 | james.fernandes@sch.nhs.uk |
Contact: Maria Burton | 0114 2717000 | maria.burton@sch.nhs.uk |
United Kingdom, South Yorkshire | |
Clinical Research Facility, Sheffield Children's Hospital | |
Sheffield, South Yorkshire, United Kingdom, S10 2TH |
Principal Investigator: | Maria Burton | Sheffield Children's Hospital |
Responsible Party: | Sheffield Children's NHS Foundation Trust ( Dr Jim Bonham ) |
Study ID Numbers: | SCH-07-006 |
Study First Received: | February 15, 2008 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00624299 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
botox limb reconstructions limb reconstruction surgery |
Pathological Conditions, Anatomical Botulinum Toxins Musculoskeletal Diseases Bone Diseases, Developmental Leg Length Inequality |
Pain Botulinum Toxin Type A Congenital Abnormalities Bone Diseases Foot Deformities |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |