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Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction |
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| Authors: | Reggie C Hamdy Kathleen Montpetit Joanne Ruck-Gibis Kelly Thorstad Ellen Raney Michael Aiona Robert Platt Allen Finley William Mackenzie James McCarthy Unni Narayanan |
| Institution: | 1. Orthopaedics., Shriners Hospital for Children, 1529 Cedar Avenue, Montreal, H3G 1A6, Canada 2. Occupational Therapy, Shriners Hospital for Children, 1529 Cedar Avenue, Montreal, H3G 1A6, Canada 3. Physical Therapy, Shriners Hospital for Children, 1529 Cedar Avenue, Montreal, H3G 1A6, Canada 4. Nursing Unit, Shriners Hospital for Children, 1529 Cedar Avenue, Montreal, H3G 1A6, Canada 5. Orthopaedics, 1310 Punahou Street, Honolulu, Hawaii, 96826-1099, USA 6. Orthopaedics. Shriners Hosptial for children, 3101 S.W. Sam Jackson Park Rd, Portland, Oregon, 97239-3095, USA 7. Biostatistics, Research Institute of Montreal Childrens Hospital, 2300 Tupper St, Montreal, QC, H3H 1P3, Canada 8. Pediatric Pain Management Service, Isaac Walton Killam Health Center, 5850 University Avenue, Halifax, NS, Canada 9. Orthopaedics. Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE, 19803-3607, USA 10. Orthopaedics. Shriners Hospital for Children, 3551 North Broad Street, Philadelphia, PA, 19140, USA 11. Orthopaedics. Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada |
| Abstract: | BackgroundDistraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis.Methods/DesignThe 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.DiscussionBTX-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.Trial RegistrationNCT00412035 |
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