TY - JOUR
T1 - Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System
T2 - Protocol for a Single-Center Clinical Cohort Study
AU - Post, Anne Mareille
AU - Berends, Hanneke I.
AU - van Royen, Barend J.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Background: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. Objective: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS. Methods: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications. Results: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024. Conclusions: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS.
AB - Background: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. Objective: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS. Methods: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications. Results: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024. Conclusions: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85182885089&origin=inward
U2 - https://doi.org/10.2196/47222
DO - https://doi.org/10.2196/47222
M3 - Article
C2 - 38145474
SN - 1929-0748
VL - 12
JO - JMIR research protocols
JF - JMIR research protocols
IS - 1
M1 - e47222
ER -