ArticleJournal of orthopaedic surgery and research2017
Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion.
Article in Journal of orthopaedic surgery and research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00951938 (A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells), which is not on this map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) in Patients Undergoing Anterior Cervical Discectomy and Fusion
Who cites it
19 citing papers in PubMed, 40 citations in OpenAlex.
- 12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery.Journal of orthopaedic surgery and research · 2023Trial
- Do Cellular Allografts Improve Spinal Fusion Enough to Justify Their Cost and Potential Risk? A Systematic Review of Efficacy, Safety, and Cost.Neurosurgery practice · 2026Review
- Efficacy of an allograft cellular bone matrix as an alternative to autograft in anterior cervical discectomy and fusion: radiological results & safety.Journal of spine surgery (Hong Kong) · 2024Article
- Could the different surgical goals of fusion and non-fusion also be achieved in combination within the same patient? Clinical and radiological outcome of hybrid cervical spine surgery.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- Cellular Bone Matrix in Spine Surgery - Are They Worth the Risk: A Systematic Review.Global spine journal · 2024Review
- Radiographic Fusion Outcomes for Trinity Cellular Based Allograft versus Local Bone in Posterolateral Lumbar Fusion.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2024Article
- The Use of Osteobiologics in Single versus Multi-Level Anterior Cervical Discectomy and Fusion: A Systematic Review.Global spine journal · 2024Article
- Comparison of Different Osteobiologics in Terms of Imaging Modalities and Time Frames for Fusion Assessment in Anterior Cervical Discectomy and Fusion: A Systematic Review.Global spine journal · 2024Article
- AO Spine Guideline for the Use of Osteobiologics (AOGO) in Anterior Cervical Discectomy and Fusion for Spinal Degenerative Cases.Global spine journal · 2024Article
- Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion.Neurology international · 2022Article
- Radiological and Clinical Outcomes after Anterior Cervical Discectomy and Fusion (ACDF) with an Innovative 3D Printed Cellular Titanium Cage Filled with Vertebral Bone Marrow.BioMed research international · 2022Article
- Management of Symptomatic Cervical Spine Pseudarthrosis: A Suggested Algorithm for Surgical Planning.International journal of spine surgery · 2021Article
- Commercial Bone Grafts Claimed as an Alternative to Autografts: Current Trends for Clinical Applications in Orthopaedics.Materials (Basel, Switzerland) · 2021Review
- Stem Cells and Spinal Fusion.International journal of spine surgery · 2021Article
- Article
- Allogenic Stem Cells in Spinal Fusion: A Systematic Review.Global spine journal · 2019Article
- Methods of Cryoprotectant Preservation: Allogeneic Cellular Bone Grafts and Potential Effects.BioMed research international · 2019Review
- ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery.International journal of spine surgery · 2018Article
- Article
Corrections and comments
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Authors and funding
10 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTrinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.
methodsIn a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months.
resultsAt both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.
conclusionsPatients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.
trial registrationTrinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.