Health-related quality of life in early onset scoliosis patients treated with the spring distraction system: what to expect in the first 2 years after surgery.

PURPOSE: The Spring Distraction System (SDS) is a novel "growth-friendly" implant for the treatment of Early-Onset Scoliosis (EOS). This prospective study aims to determine the evolution of the "24-Item Early-Onset Scoliosis Questionnaire" (EOSQ-24) scores during 2-year follow-up after SDS surgery. Secondary aims include investigating the relation between EOSQ-24 scores and EOS etiology, and evaluating the impact of an unplanned return to the operating room (UPROR) on HRQoL. METHODS: All SDS patients with at least 2-year follow-up were included. Caregivers completed the EOSQ-24 pre-operatively, post-operatively, and at 6, 12, and 24 month follow-up. Mean total and -domain scores were graphed over time. Repeated-measures ANOVA analyzed the influence of etiology on EOSQ-24 scores. Multiple regression analyzed associations between UPRORs and EOSQ-24 scores. RESULTS: Forty-nine patients were included. Mean total EOSQ-24 scores decreased from 70 pre-operatively to 66 post-operatively, then gradually increased to 75 (24 months). Most domains exhibited changes over time, with initial declines, but eventually surpassing pre-operative levels after 2-year follow-up. Neuromuscular/Syndromic patients had lower scores, but showed similar improvements over time compared with other etiologies. Multiple regression showed lower Parental Burden domain score (- 14 points) in patients with UPRORs, although no significant reductions were found in total score, or in other domains. CONCLUSION: HRQoL decreases immediately following SDS surgery but quickly recovers and exceeds pre-operative levels at 2-year follow-up in all domains. Neuromuscular/Syndromic patients have lower initial scores, but progress similarly over time. UPRORs do not influence EOSQ-24 scores, except for a negative impact on the Parental Burden domain in the short term. LEVEL OF EVIDENCE: III.

The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial.

Background: The Spring Distraction System (SDS) is a dynamic growth-friendly implant to treat early onset scoliosis (EOS). Previous SDS studies showed promising results in terms of curve correction and complication profile. Nevertheless, complications did occur, which led to modifications in the implant design. The main iterations were a larger rod diameter and a more sagittal stable sliding mechanism. The purpose of this study was to investigate the performance of these iterations. Methods: All patients treated with the modified SDS and >1 year follow-up were included. Radiographic outcomes, severe adverse events (SAEs), unplanned returns to the operating room (UPRORs) and health-related quality of life (HRQoL) were investigated. Results: Seventeen EOS patients (three congenital, four idiopathic, nine neuromuscular, one syndromic) were included. Mean age at surgery was 9.5 ± 2.5 years. Similar to the first generation SDS, about 50% initial correction was achieved and maintained, and spinal growth was near physiological. Most importantly, SAEs and UPRORs were diminished and favorable with 0.10/patient/year. In addition, HRQoL increased during the first year postoperatively, indicating the implant was well accepted. Conclusion: These preliminary results indicate that the iterations of the SDS are effective in terms of reducing SAEs and UPRORs and increasing HRQoL in patients with EOS.