Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR)

Abstract

Background Early Onset Scoliosis (EOS) is a progressive spinal deformity in children, and a potentially life-threatening disease. “Growth-friendly” surgical techniques aim to control the deformity, while allowing the spine and trunk to maintain growth. Current “growth-friendly” systems such as the traditional growing rod (TGR) and magnetically controlled growing rod (MCGR) have limitations that reduce their efficacy and cost-effectiveness. Recently, two “growth-friendly” systems have been developed that mitigate many of these limitations, the Spring Distraction System (SDS) and the One Way Self-Expanding Rod (OWSER). The purpose of the multicenter BiPOWR trial is to investigate, describe and compare the 1-year limited-efficacy and -safety of both strategies in the treatment of neuromuscular EOS. Methods After informed consent, 28 neuromuscular EOS patients will be randomized to receive either the SDS or the OWSER. Patients and caregivers will be blinded to allocation until after surgery. Primary outcomes will be maintenance of coronal curve correction and the occurrence of serious adverse events. In addition, spinal growth, implant lengthening, and perioperative findings are recorded systematically. At each follow-up moment, the Early Onset Scoliosis Questionnaire (EOSQ-24) will be used to assess health-related quality of life. All outcomes will be compared between groups. Discussion The BiPOWR trial is the first randomized controlled trial that compares two specific “growth-friendly” implants in a specified EOS population. It will determine the 1-year limited-efficacy and safety of the SDS and OWSER implants. Trial registration Clinicaltrials.gov: NCT04021784 (13–06-2019). CCMO registry: NL64018.041.17 (06–05-2019).

The Minimally Invasive Bipolar Fixation for Pediatric Spinal Deformities: A Narrative Review

“…A protocol is underway to compare the benefits of this self-expanding rod in patients with neuromuscular scoliosis with the Spring Distraction System, which is also a "growthfriendly" system [45].…”

Reply to Tabeling et al. Comment on “Grabala et al. Radiological Outcomes of Magnetically Controlled Growing Rods for the Treatment of Children with Various Etiologies of Early-Onset Scoliosis—A Multicenter Study. J. Clin. Med. 2024, 13, 1529”

“…It is essential to acknowledge that the methodology of MCGR placement that we employ [ 20 , 21 , 22 ] incorporates minimally invasive entry (restricts spontaneous spondylodesis), along with the utilization of larger transpedicular screw dimensions (to mitigate the risk of pull-out and enhance biomechanical characteristics) [ 21 ], which may exert a notable influence on clinical and radiological outcomes and the potential for complications and subsequent interventions [ 13 , 14 ], thereby potentially diminishing the ultimate results for T1–T12, T1–S1, and the definitive rectification of spinal deformity. Imperfections exist in all implants; yet we anticipate that our investigations and findings, as well as those of the authors of the commentary [ 1 , 23 , 24 , 25 ], will contribute to substantial advancements and enhancements in the surgical management of early-onset scoliosis.…”