Post-marketing surveillance on safety and efficacy of posterior spinal correction and fusion with the CD Horizon Solera instrumentation for adolescent idiopathic scoliosis. A retrospective cohort study

BACKGROUND: Post-Market Clinical Follow-Up has been integrated into the new Medical Device Regulations since 2020. The CD Horizon Solera 4.75 mm instrumentation (CD-Solera) was introduced worldwide in 2009, and specifically intended for surgical treatment of pediatric and adolescent scoliosis patients. The objective of this study was to evaluate the safety and efficacy of the CD-solera 4.75 instrumentation in surgical treatment of adolescent idiopathic scoliosis (AIS). METHODS: 94 consecutive AIS patients, 82 female, 12 male, who underwent posterior correction with CD-Solera instrumentation between 2010 and 2016 at age 14.8 ± 1.6 years, were retrospectively included. The minimum follow-up was two years. On pre- and postoperative biplanar full spine radiographs Cobb angles of the primary and secondary curves and sagittal profile were measured before surgery, immediately postoperative, and at two-year follow-up. Medical records were reviewed for complications. Clinical outcome was analyzed using theSRS-22r questionnaire. RESULTS: In this study 77% of the patients had a structural thoracic curve (type Lenke 1 or 2), and 23% had a structural (thoraco-)lumbar curve (Lenke 3-6). A correction of 55.1% and 51.7% was achieved respectively immediately post-operative, and at last-year follow up for the primary curve. The mean loss of correction was 2°. Health related quality of life was 4.0 (good) on the SRS-22r-questionnaire. In total six revision operations were executed, of which one was related to the material (rod breakage). Other reasons for revision operation were not due to the material. No neurological problems were encountered. CONCLUSION: In patients with AIS the initial correction and maintenance of correction as achieved by posterior spinal fusion using the CD-Solera instrumentation, is comparable to other reported devices. Complication rates are low and health related quality of life comparable to literature. The CD-Solera can be regarded as a safe and effective instrumentation in surgical treatment of AIS.