Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5–21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada.BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and deformity correction.NCT00412035Lower extremity limb deformity and length discrepancy can occur secondary to congenital anomalies (such as fibular hemimelia or Blount's disease) or traumatic, infective or neoplastic events leading to partial or total physeal arrest. If the discrepancy exceeds 3 to 5 cm, then equalizing limb length would be the ideal treatment [1].Since the first bone lengthening procedure performed on a human patient by distraction was reported by Codivilla in 1905 [2], numerous techniques for lengthening bones and correcting deformity have been developed, but these were fraught with unacceptably high complication rates [3]. Then the Russian orthopaedic surgeon Gavriel Ilizarov developed new principles in limb lengthening. Working in the small Siberian community of Kurgan, he found that after a delay of a few days fol