title: Innovation in growing rod technique: a study of safety and efficacy of a magnetically controlled growing rod in a porcine model.
abstract: STUDY DESIGN.: Prospective in vivo randomized study. OBJECTIVE.: To evaluate the safety and efficacy of a distraction-based magnetically controlled growing rod (MCGR) in a porcine model. SUMMARY OF BACKGROUND DATA.: A high number of complications related to frequent surgical rod lengthenings has been a generally accepted outcome in growing rod surgery for early-onset scoliosis. A potentially safer technique is a system that does not require repetitive surgery. METHODS.: Seven-month-old pigs were randomly assigned to an experiment group (EG; n = 6) and a sham group (SG; n = 3). One animal in the EG became paralyzed because of a misplaced pedicle screw and was killed per the study protocol. Therefore, a total of 8 animals completed the study. The EG underwent weekly spine distraction using the MCGR. Spinal height was assessed by vertebral unit height measurements on weekly lateral radiographs. RESULTS.: A total of 49 mm of distraction across the unfused vertebral levels was planned during a 7-week period (7 mm per wk). Radiographical analysis of the MCGR device revealed an average distraction of 39 mm (range, 32-46 mm), resulting in achievement of 80% of predicted spinal height. Prior to removal of implants, spinal height for the EG was similar to the SG. However, accelerated increase in vertebral unit height was noted in the EG during the 3-week period after implant removal, which resulted in significantly greater overall spinal height in the EG (32.2% vs. 11.7%, P ≤ 0.05). No MCGR-related complications occurred. CONCLUSION.: The MCGR provided 80% of predicted spinal height by noninvasive remote distraction in this animal model. The accelerated increase in spinal height of the experimental animals after implant removal was an unexpected finding which requires additional research to better understand the effect of distraction on spinal growth. This study establishes a foundation for future research in an attempt to use a less invasive technique in distraction-based correction of early-onset scoliosis.
authors.affiliation: San Diego Center for Spinal Disorders, La Jolla, CA, USA. akbarnia@ucsd.edu
authors.forename: Behrooz A
authors.initials: BA
authors.lastname: Akbarnia
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Mundis
authors.forename: Pooria
authors.initials: P
authors.lastname: Salari
authors.forename: Burt
authors.initials: B
authors.lastname: Yaszay
authors.forename: Jeff B
authors.initials: JB
authors.lastname: Pawelek
mesh_terms: D000818:Animals; D004867:Equipment Design; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000254:growth & development / Q000601:surgery*; D008280:Magnetics / Q000295:instrumentation; D023421:Models, Animal; D019857:Osteogenesis, Distraction / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D011859:Radiography; D012600:Scoliosis / Q000601:surgery*; D013552:Swine; D013556:Swine, Miniature; D013904:Thoracic Vertebrae / Q000000981:diagnostic imaging / Q000254:growth & development / Q000601:surgery*; D013997:Time Factors