JMIR Publications

ABSTRACT

Background:

The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) with a Cobb angle of ≥45-50 degrees consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of PSF in AIS patients. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis (EOS) and neuromuscular scoliosis (NMS). It may be questioned if minimally invasive posterior spinal non-fusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. A study protocol is presented to monitor the efficacy and safety of PSnF surgery by using bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS.

Objective:

The objective of the article is to present a study protocol to monitor the efficacy and safety of PSnF surgery by using bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS.

Methods:

Patients will be requited during visits to the Amsterdam University Center. In selected AIS patients with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is considered 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. A commercially available CE-certified spinal implant was used as instrumentation. The power analysis calculated 14 AIS patients for assessment. Patients will be followed over time, according to standard medical care.

Results:

A total of 14 patient will be included in the time period between 2021 and december 2025. As of March 2023, we have included 4 patients in this study and expect to finalize inclusion by december 2025. Data collection will be started in May 2023 and will continue until all included patients have reached the end of growth + 2 years. The first one year results are expected to be published in the fall of 2023.

Conclusions:

Minimally invasive PSnF in AIS patients 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. It is possible that PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS. Clinical Trial: NCT04442422, June 22 2020