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

Autor: Jemin Yi, Gun Woo Lee, Woo Dong Nam, Kye Young Han, Myung-Ho Kim, Jong Won Kang, Jonghwa Won, Seong Wan Kim, Won Noh, Jin S Yeom
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Asian Spine Journal, Vol 9, Iss 1, Pp 30-38 (2015)
Druh dokumentu: article
ISSN: 1976-1902
1976-7846
DOI: 10.4184/asj.2015.9.1.30
Popis: Study DesignProspective randomized noninferiority trial.PurposeTo 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 LiteratureThere have been no clinical trials investigating the outcomes of a mixture of HA and DBM in a PEEK cage in ACDF.MethodsEighty-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.ResultsSeventy-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.ConclusionsA HA/DBM mixture inside a PEEK cage can provide noninferior outcomes compared to a HA/TCP mixture in ACDF.
Databáze: Directory of Open Access Journals
Externí odkaz: