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

Abstract

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.

Evaluation of bony fusion after anterior cervical discectomy: a systematic literature review

“…They found fusion was achieved in 93.5% of patients after a median follow-up of 23 months. In the other 12 articles, the analysis was performed by a clinician, usually a neuro-or orthopaedic surgeon [12,29,35,61,67,69,87,92,96,[109][110][111]. They found fusion was achieved in 85.5% of patients after a median follow-up of 23 months.…”

Adenovirus-Mediated Expression of BMP-2 and BFGF in Bone Marrow Mesenchymal Stem Cells Combined with Demineralized Bone Matrix For Repair of Femoral Head Osteonecrosis in Beagle Dogs

“…Allograft tissue was used to create the DBM, which also contained BMPs, collagen, and synergistic proteins including transforming growth factor and insulin-like growth factor. The presence of this milieu suggests that the DBM had both osteoinductive and osteoconductive ability, which led to excellent bony fusion [23, 24]. Compared to recombinant growth factors, DBM is less expensive and is not limited in quantity.…”

Bone Union Rate Following Instrumented Posterolateral Lumbar Fusion: Comparison between Demineralized Bone Matrix versus Hydroxyapatite

“…Ideal graft materials or graft substitutes should have three basic biologic attributes of osteogenicity, osteoconductivity, and osteoinductivity [1011]. Demineralized bone matrix (DBM) has been utilized as a graft substitute because of its osteoinductivity [4712].…”