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.
- Yi, Jemin; Lee, Gun Woo; Nam, Woo Dong; Han, Kye Young; Kim, Myung-Ho; Kang, Jong Won; Won, Jonghwa; Kim, Seong Wan; Noh, Won; Yeom, Jin S.
- Issue Date
- Asia Pacific Spine Society
- Asian Spine Journal, vol.9 no.1, pp. 30-38
- Anterior cervical discectomy and fusion; Polyetheretherketone cage; Hydroxyapatites; Demineralized bone matrix; Betatricalcium
- 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
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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