Study design: Prospective multicenter international observational study. Objective: To investigate the effect of implant density on clinical outcomes in complex pediatric spine reconstruction. Summary of background data: Implant density in spine deformity surgery has been a subject of much debate with some authors advocating higher density for better correction. Few studies have looked at the effect of implant density on severe curves > 100 deg or treated with vertebral column resection (VCR). Methods: 250/311 pts with 2-year f/u enrolled in the FOX pediatric database from 17 international sites were queried for the impact of implant density and surgical outcomes. Patients were grouped into three implant density categories for comparative analysis Group 1 (density ≤ 1), Group 2 (1 < density < 1.5) and Group 3 (density; 1.5–2). Results: 250 pts: 47 (Grp1)/99 (Grp2) /104 (Grp3); Pre-op age and etiology and curve types were similar in all groups, but body mass index (BMI) was higher in Grp3. Grps 1 and 2 had significantly higher sagittal deformity angular ratio (S-DAR) compared to Grp 3 (p < 0.001). Pre-op Halo Gravity Traction (HGT) was used in 55.3%/44.4%/31.7%, p = 0.017; Grp1/Grp2/Grp3, respectively. Average duration of surgery (min) was higher in Grp3 relative to Grp1 only: 352.5/456.5/515.0, p = 0.0029. Blood loss was similar in all Grps. Rate of VCR, PSO and SPO was similar in all Grps. Pre-op Coronal Cobb avg 96.1/83.6/88.6, p = 0.2342, attained similar correction after HGT (24.6%/27.2%/23.2%, p = 0.4864. Coronal Cobb corrections at 2-year follow-up (FU) were (37.1%/40.3%/53.5%, p = 0.0004). Pre-op sagittal Cobb was (105.4/101.9/75.9, p < 0.01.), achieved similar %correction in HGT (19.1%/22.3%/22.5%, p = 0.6851) and at 2-year FU (39.6%/41.4%/29.8%, p = 0.1916). After adjusting for C-DAR, S-DAR, pre-op coronal and sagittal Cobb, etiology, curve types, age, BMI and number of rods in multivariate analysis, the odds of developing post-operative implant complication was 11 times greater in group 1 compared to group 3 (OR = 11.17,95% CI 2.34–53.32). There was significant improvement in SRS scores in all Grps at 2-year FU. Conclusion: Although higher implant density was observed to be associated with greater curve correction and lower rates of post-operative implant-related complication and revision in heterogeneous case groups, the results may not imply causality of implant density on the outcomes in severe pediatric spine reconstruction.
