Abstract
PURPOSE OF THE STUDY: The objective of this prospective, parallel, randomized, single-center study is to evaluate the clinical success of a commercial ceramic bone graft substitute (CBGS) for autograft in eXtreme Lateral Interbody Fusion (XLIF) procedures. Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 1 Given name: [Cristiano Magalhães], Last name [Menezes]. Author 2 Given name: [Gabriel Carvalho], Last name [Lacerda]. Author 5 Given name: [Erica Godinho], Last name [Menezes]. Also, kindly confirm the details in the metadata are correct.yes METHODS: Forty-five adult subjects were consecutively enrolled and randomized into a single-level XLIF procedure using either CBGS or iliac crest bone graft autograft (30 and 15 subjects, respectively). The primary outcome was fusion rate at 12, 18, and 24 months. Secondary outcomes were pain and disability measured by HRQOL questionnaires. Kindly check and confirm whether the corresponding author and his corresponding affiliations is correctly identified.yes RESULTS: The fusion rates for both CBGS and autograft groups at the 24-month follow-up were 96.4% and 100%, respectively. For the CBGS group, mean ODI, mean back pain, and mean worst leg pain significantly improved at the 24-month follow-up by 76.7% (39.9-9.3), 77.6% (7.3-1.6), and 81.3% (5.1-1.0), respectively. For the autograft group, mean ODI, mean back pain, and mean worst leg pain significantly improved during the same time period by 77.1% (35.9-8.2), 75.6% (6.1-1.5), and 86.0% (6.6-0.9), respectively (all time points between groups, p < 0.05). CONCLUSION: The results of this prospective, randomized study support the use of CBGS as a standalone bone graft substitute for autograft in single-level XLIF surgery. The clinical performance and safety outcomes reported here are consistent with published evidence on CBGS. Improvements in patient-reported back pain, leg pain, and disability outcomes were comparable between the CBGS and autograft groups.