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.
- Author:
Jemin YI
1
;
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
Author Information
- Publication Type:Clinical Trial ; Randomized Controlled Trial ; Original Article
- Keywords: Anterior cervical discectomy and fusion; Polyetheretherketone cage; Hydroxyapatites; Demineralized bone matrix; Beta-tricalcium phosphate
- MeSH: Bone Matrix*; Diskectomy*; Durapatite; Humans; Hydroxyapatites; Neck; Prospective Studies*; Tomography, X-Ray Computed
- From:Asian Spine Journal 2015;9(1):30-38
- CountryRepublic of Korea
- Language:English
- Abstract: 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 beta-tricalcium phosphate (beta-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 beta-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.
