Dataset Information

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 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 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 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.

SUBMITTER: Yi J

PROVIDER: S-EPMC4330216 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Publications

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 J Lee Gun Woo GW Nam Woo Dong WD Han Kye Young KY Kim Myung-Ho MH Kang Jong Won JW Won Jonghwa J Kim Seong Wan SW Noh Won W Yeom Jin S JS

Asian spine journal 20150213 1

<h4>Study design</h4>Prospective randomized noninferiority trial.<h4>Purpose</h4>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.<h4>Overview of literature</h4>There have been no clinical trials investigating the outcomes of a mixture of HA and DBM in a PEEK cage in ...[more]

PMID: 25705332

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Project description:A CaO-SiO2-P2O5-B2O3 bioactive glass-ceramic (BGS-7) spacer provides high mechanical stability, produces a chemical bond to the adjacent endplate, and facilitates fusion after spine surgery. This prospective, randomized, single-blind, non-inferiority trial aimed to evaluate the radiographic outcomes and clinical efficacy of anterior cervical discectomy and fusion (ACDF) using a BGS-7 spacer for treating cervical degenerative disorders. Thirty-six patients underwent ACDF using a BGS-7 spacer (Group N), and 40 patients underwent ACDF using polyetheretherketone (PEEK) cages filled with a mixture of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP) for the treatment of cervical degenerative disorders. The spinal fusion rate was assessed 12 months postoperatively using three-dimensional computed tomography (CT) and dynamic radiographs. Clinical outcomes included patient-reported outcome measures, visual analog scale scores for neck and arm pain, and scores from the neck disability index (NDI), European Quality of Life-5 Dimensions (EQ-5D), and 12-item Short Form Survey (SF-12v2). All participants were randomly assigned to undergo ACDF using either a BGS-7 spacer or PEEK cage filled with HA and β-TCP. The primary outcome was the fusion rate on CT scan image at 12 months after ACDF surgery based on a per-protocol strategy. Clinical outcomes and adverse events were also assessed. The 12-month fusion rates for the BGS-7 and PEEK groups based on CT scans were 81.8% and 74.4%, respectively, while those based on dynamic radiographs were 78.1% and 73.7%, respectively, with no significant difference between the groups. There were no significant differences in the clinical outcomes between the two groups. Neck pain, arm pain, NDI, EQ-5D, and SF-12v2 scores significantly improved postoperatively, with no significant differences between the groups. No adverse events were observed in either group. In ACDF surgery, the BGS-7 spacer showed similar fusion rates and clinical outcomes as PEEK cages filled with HA and β-TCP.

Project description:Among interbody implants used during anterior cervical discectomy and fusion (ACDF), structural allografts and polyetheretherketone (PEEK) are the most used spacers. Currently, no consensus has been established regarding the superiority of either implant, with US surgeons preferring structural allografts, whereas UK surgeons preferring PEEK. The purpose of this systematic review (level of evidence, 4) was to compare postoperative and patient-reported outcomes between the use of structural allografts PEEK interbody spacers during ACDF. Five electronic databases (PubMed, Embase, Scopus, Web of Science, and Cochrane) were searched for articles comparing the usage of structural allograft and PEEK interbody spacers during ACDF procedures from inception to April 10, 2023. The searches were conducted using the keywords "Spine," "Allograft," and "PEEK" and were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Subsequent quality and sensitivity analyses were performed on the included studies. Nine studies involving 1,074 patients were included. Compared with the PEEK group, the structural allograft group had comparable rates of postoperative pseudoarthrosis (p=0.58). However, when stratified according to the number of levels treated, the 3-level ACDF PEEK group was 3.45 times more likely to have postoperative pseudoarthrosis than the structural allograft group (p=0.01). Subsequent postoperative outcomes (rate of subsidence and change in the preoperative and postoperative segmental disc heights) were comparable between the PEEK and structural allograft groups. Patient-reported outcomes (Visual Analog Scale [VAS] of neck pain and Neck Disability Index [NDI]) were comparable. This study showed that for 3-level ACDFs, the use of structural allografts may confer higher fusion rates. However, VAS neck pain, NDI, and subsidence rates were comparable between structural allografts and PEEK cages. In addition, no significant difference in pseudoarthrosis rates was found between PEEK cages and structural allografts in patients undergoing 1- and 2-level ACDFs.

Dataset Information

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.

Study design

Purpose

Overview of literature

Methods

Results

Conclusions

Publications

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.

Similar Datasets

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