Asian Spine J.
2015 Feb;9(1):30-38. 10.4184/asj.2015.9.1.30.
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
- Affiliations
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- 1Department of Orthopaedic Surgery, Kangwon National University College of Medicine, Chuncheon, Korea.
- 2Department of Orthopaedic Surgery, Armed Forces Yangju Hospital, Yangju, Korea. gwlee1871@gmail.com
- 3Department of Orthopaedic Surgery, Dankook University College of Medicine, Cheonan, Korea.
- 4Department of Orthopaedic Surgery, Sun General Hospital, Daejeon, Korea.
- 5Department of Orthopaedic Surgery, Chamjoeun Hospital, Gwangju, Korea.
- 6Department of Orthopaedic Surgery, National Police Hospital, Seoul, Korea.
- 7Department of Orthopaedic Surgery, Uijung-bu Chuk Hospital, Uijung-bu, Korea.
- 8Spine Center and Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Sungnam, Korea.
- KMID: 2270190
- DOI: http://doi.org/10.4184/asj.2015.9.1.30
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.
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