Summary: Results of a meta‐analysis of the published English literature conducted by SRS and POSNA task force revealed that accuracy of pedicle screw placement in the pediatric spine is comparable to accuracy rate reported in adults. PS constructs are significantly more effective in %Cobb correction with a large effect size compared to hook and hybrid constructs
Introduction: Pedicle screws (PS) have revolutionized the surgical treatment of spinal deformity and are extensively used in adults and children. Despite being standard of care for pediatric spinal deformity, pedicle screw systems have not been FDA approved in pediatric populations, and are used as a physician directed application. With support from the Scoliosis Research Society and the Pediatric Orthopaedic Society of North America, a meta‐analysis was performed to determine the safety and efficacy of pedicle screw use in pediatric patients
Methods: Pubmed was searched for English language studies of PS use in pediatric patients (<18yrs). Comparison of PS accuracy and effect size comparison for Cobb correction was done
Results: Of 1181 articles, 320 pertinent abstracts were reviewed. 90 full‐text articles selected. 35 studies met inclusion criteria for the meta‐analysis. 19 studies for PS placement accuracy yielded a total of 13,536 pedicles screws in 1,353 pediatric spine deformity patients. 689 of 13,536 screws were reported misplaced, for an overall accuracy of 95%. The weighted, geometric and 5% trimmed mean accuracy of PS placement were 92%, 88%, and 89% respectively (SD=10%;IQR=10%). 16 comparative studies for the effect size analysis showed PS constructs had significantly larger %Cobb angle correction means compared to hook constructs (Cohen d=1.14; 95%CI=‐4.4,10.7) and hybrid constructs (Cohen d=0.49; 95%CI=‐5.1,7.3)
Conclusion: Accuracy of pedicle screw placement in the pediatric spine (95%) exceeds the accuracy rate reported in adults (91%). Based on this, the safety of pedicle screw spinal systems in the skeletally immature population should be considered equivalent to that shown in adults. PS constructs are significantly more effective in %Cobb correction with a large effect size compared to hook and hybrid constructs.
The FDA has not cleared the drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an ‘off label’ use).