A Prospective Randomized Clinical Trial Comparing Bone Union Rate Following Anterior Cervical Discectomy and Fusion Using a Polyetheretherketone Cage: Hydroxyapatite/ Β-Tricalcium Phosphate Mixture versus Hydroxyapatite/Demineralized Bone Matrix Mixture

• Published in: Asian spine journal pp. 30 - 38
• Main Authors: 이제민, 이건우, 남우동, 한계영, 김명호, 강종원, 원종화, 김성완, 노원, 염진섭
• Format: Journal Article
• Language: English
• Published: 대한척추외과학회 01.02.2015
• Subjects: 정형외과학
• ISSN: 1976-1902; 1976-7846

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. KCI Citation Count: 1