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
Asian Spine Journal
;
: 30-38, 2015.
Article
Dans Anglais
| WPRIM
| ID: wpr-185083
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Trame osseuse
/
Tomodensitométrie
/
Études prospectives
/
Durapatite
/
Discectomie
/
Hydroxyapatites
/
Cou
Type d'étude:
Essai clinique contrôlé
/
Étude observationnelle
Limites du sujet:
Humains
langue:
Anglais
Texte intégral:
Asian Spine Journal
Année:
2015
Type:
Article
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