Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial
A CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> bioactive glass-ceramic (BGS-7) spacer provides high mechanical stability, produces a chemical bond to the adjacent endplate, and facilitates fusion after spine sur...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-06-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/12/12/4069 |
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| author | Jiwon Park Sang-Min Park Dae-Woong Ham Jae-Young Hong Ho-Joong Kim Jin S. Yeom |
| author_facet | Jiwon Park Sang-Min Park Dae-Woong Ham Jae-Young Hong Ho-Joong Kim Jin S. Yeom |
| author_sort | Jiwon Park |
| collection | DOAJ |
| description | A CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> 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. |
| first_indexed | 2024-03-11T02:18:42Z |
| format | Article |
| id | doaj.art-b14befa4a9f84218bb99f46fad96ab4b |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-11T02:18:42Z |
| publishDate | 2023-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-b14befa4a9f84218bb99f46fad96ab4b2023-11-18T11:00:33ZengMDPI AGJournal of Clinical Medicine2077-03832023-06-011212406910.3390/jcm12124069Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled TrialJiwon Park0Sang-Min Park1Dae-Woong Ham2Jae-Young Hong3Ho-Joong Kim4Jin S. Yeom5Department of Orthopedic Surgery, Korea University Ansan Hospital, Ansan-si 15355, Republic of KoreaSpine Center and Department of Orthopedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam 13620, Republic of KoreaDepartment of Orthopedic Surgery, Chung-Ang University Hospital, College of Medicine, Chung-Ang University, Seoul 06974, Republic of KoreaDepartment of Orthopedic Surgery, Korea University Ansan Hospital, Ansan-si 15355, Republic of KoreaSpine Center and Department of Orthopedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam 13620, Republic of KoreaSpine Center and Department of Orthopedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam 13620, Republic of KoreaA CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> 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.https://www.mdpi.com/2077-0383/12/12/4069ACDFcervicalfusion rateglass ceramicsPEEK cage |
| spellingShingle | Jiwon Park Sang-Min Park Dae-Woong Ham Jae-Young Hong Ho-Joong Kim Jin S. Yeom Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial Journal of Clinical Medicine ACDF cervical fusion rate glass ceramics PEEK cage |
| title | Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial |
| title_full | Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial |
| title_fullStr | Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial |
| title_full_unstemmed | Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial |
| title_short | Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO<sub>2</sub>-P<sub>2</sub>O<sub>5</sub>-B<sub>2</sub>O<sub>3</sub> Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial |
| title_sort | anterior cervical discectomy and fusion performed using a cao sio sub 2 sub p sub 2 sub o sub 5 sub b sub 2 sub o sub 3 sub bioactive glass ceramic or polyetheretherketone cage filled with hydroxyapatite β tricalcium phosphate a prospective randomized controlled trial |
| topic | ACDF cervical fusion rate glass ceramics PEEK cage |
| url | https://www.mdpi.com/2077-0383/12/12/4069 |
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