Dados do Trabalho

Título

Ceramic Bone Graft Substitute vs Autograft in XLIF: A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes

Objetivo

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.

Metodologia

Forty-five adult subjects were consecutively enrolled and randomized into a single-level XLIF procedure using either CBGS or iliac crest bone graft (ICBG) 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.

Resultados

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 to 9.3), 77.6% (7.3 to 1.6), and 81.3% (5.1 to 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 to 8.2), 75.6% (6.1 to 1.5), and 86.0% (6.6 to 0.9), respectively (all time points between groups, p<0.05).

Conclusões

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.

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