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KMID : 1189320150090010030
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Asian Spine Journal
2015 Volume.9 No. 1 p.30 ~ p.38
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A Prospective Randomized Clinical Trial Comparing Bone Union Rate Following Anterior Cervical Discectomy and Fusion Using a Polyetheretherketone Cage: Hydroxyapatite/B-Tricalcium Phosphate Mixture versus Hydroxyapatite/Demineralized Bone Matrix Mixture
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Yi Je-Min
Lee Gun-Woo
Nam Woo-Dong
Han Kye-Young
Kim Myung-Ho
Kang Jong-Won
Won Jong-Hwa
Kim Seong-Wan
Noh Won
Yeom Jin-S.
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Abstract
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Study Design: Prospective randomized noninferiority trial.
Purpose: To evaluate whether the union rate of anterior cervical discectomy and fusion (ACDF) using a polyetheretherketone (PEEK) cage filled with a mixture of hydroxyapatite (HA) and demineralized bone matrix (DBM) is inferior to that of a mixture of β-tricalcium phosphate (β-TCP) and HA.
Overview of Literature: There have been no clinical trials investigating the outcomes of a mixture of HA and DBM in a PEEK cage in ACDF.
Methods: Eighty-five eligible patients were randomly assigned to group B (n=43), in which a PEEK cage with a mixture of HA and DBM was used, or group C (n=42), in which a PEEK cage with a mixture of HA and β-TCP was used. The primary study endpoint was the fusion rate, which was assessed with dynamic radiographs and computed tomography (CT) scans. Secondary endpoints included pain intensity using a visual analogue scale, functional outcome using a neck disability index score, laboratory tests of inflammatory profiles, and the infection rate.
Results: Seventy-seven patients (38 in group B and 39 in group C) were included in the final analysis. One year postoperatively, bone fusion was achieved in 87% of group B patients and 87% of group C patients on dynamic radiographs, and 87% of group B patients and 72% of group C patients on CT scans (p=1.00 and 0.16, respectively). There were also no between-groups differences with respect to the secondary endpoints.
Conclusions: A HA/DBM mixture inside a PEEK cage can provide noninferior outcomes compared to a HA/TCP mixture in ACDF.
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KEYWORD
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Anterior cervical discectomy and fusion, Polyetheretherketone cage, Hydroxyapatites, Demineralized bone matrix, Beta-tricalcium phosphate
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