Surgical Treatment of Adolescent Idiopathic Scoliosis with the ApiFix Minimal Invasive Dynamic Correction System-A Preliminary Report of a 24-Month Follow-Up.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional growth disorder. Corrective surgical procedures are the recommended treatment option for a thoracic angle exceeding 50° and a lumbar major curve of 40°. Over the past few years, dynamic growth modulation implants have been developed as alternatives to permanent fusion. The ApiFix system was designed as a 2D "posterior dynamic device" for curve correction. After implantation in a minimally invasive procedure, it uses polyaxial joints and a self-adjusting rod to preserve the degree of motion and to accommodate the patient's growth. It provides an effective method of controlling deformity and fills the gap between the conservative treatment of major curves that are >35° and the fusion procedure. The objective of the two-center cohort study was the analysis of the correction results of patients, who underwent surgical intervention with the ApiFix system. The inclusion criteria were AIS, Lenke type 1 or type 5, a major curve on bending films of ≤30°, and an angle of the major curve of between 35° and 60°. Postoperative radiograph data were obtained longitudinally for up to 24 months of follow-up and compared to preoperative (preop) values. For comparisons of the different time points, non-parametric tests (Wilcoxon) or paired -tests for normally distributed values were used to analyze repeated measures. Overall, 36 patients (25 female and 11 male) were treated with the ApiFix system from April 2018 to October 2020. Lenke type 1 was identified in 21 (58%) cases and Lenke type 5 was identified in 15 (42%) cases. The average angle of the thoracic major curve for Lenke 1 was 43°. The preoperative lumbar major curve (Lenke 5) was determined to be 43°. Over a follow-up of 24 months, a correction of the major curve to an average of 20° was observed for Lenke 1 and that to an average of 15° was observed for Lenke 5. Lenke type 1 and type 5 showed significant changes in the major curve over the individual test intervals in the paired comparisons compared to the starting angle (Lenke 1: preop-24 months, 0.002; Lenke 5: preop-24 months, 0.043). Overall, 11 events were recorded in the follow-up period, that required revision surgery. We distinguished between repeated interventions required after reaching the maximum distraction length of the implant due to the continued growth of the patient (n = 4) and complications, such as infections or problems associated with the anchorage of the implant (n = 7). The results from the present cohort revealed a statistically significant improvement in the postoperatively measured angles of the major and minor curves in the follow-up after 24 months. Consequently, the results were comparable to those of the already established vertebral body tethering method. Alignment in AIS via dynamic correction systems in combination with a possible growth modulation has been a treatment alternative to surgical fusing procedures for more than a decade. However, the long-term corrective effect has to be validated in further studies.