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).

Tytuł:: 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).
Autorzy:: Lemans JVC; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. .
Tabeling CS; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Scholten EP; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Stempels HW; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Miladi L; Hôpital Necker-Enfants Malades, Paris, France.
Castelein RM; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Kruyt MC; Department of Orthopaedic Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.; Twente University, Enschede, The Netherlands.
Źródło:: BMC musculoskeletal disorders [BMC Musculoskelet Disord] 2023 Jan 10; Vol. 24 (1), pp. 20. Date of Electronic Publication: 2023 Jan 10.
Typ publikacji:: Clinical Trial Protocol; Journal Article
Język:: English
Imprint Name(s):: Original Publication: London : BioMed Central, [2000-
MeSH Terms:: Scoliosis*/surgery
Orthopedic Procedures*/methods
Child ; Humans ; Quality of Life ; Spine/surgery ; Prostheses and Implants ; Retrospective Studies ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
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Grant Information:: NA Euros
Contributed Indexing:: Keywords: BiPOWR; Bipolar technique; Early Onset Scoliosis; Growth; Neuromuscular; OWSER; One Way Self-Expanding Rod; Pediatric spine; SDS; Spring Distraction System
Molecular Sequence:: ClinicalTrials.gov NCT04021784
Entry Date(s):: Date Created: 20230110 Date Completed: 20230112 Latest Revision: 20230113
Update Code:: 20240105
PubMed Central ID:: PMC9830923
DOI:: 10.1186/s12891-022-06048-4
PMID:: 36627616
: Czasopismo naukowe

Pełny tekst

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).
(© 2023. The Author(s).)

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