Trial reportSpine2020
Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial.
Trial report in Spine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- Ceramic bone graft substitute vs autograft in XLIF: a prospective randomized single-center evaluation of radiographic and clinical outcomes.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 · 2022Trial
- Comparative analysis of autograftJournal of spine surgery (Hong Kong) · 2026Article
- A pre-market, open-label, single-arm study to evaluate b.Bone for posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal disease (b.Spine clinical trial).Frontiers in bioengineering and biotechnology · 2026Article
- Therapeutic Approaches for Enhancing Spinal Fusion in Low Back Pain: A Review With a Focus on the Elderly.JOR spine · 2025Review
- Comparative Performance of Calcium Phosphate Grafts and Iliac Crest Autograft in Posterolateral Spinal Fusion in Rabbits.JOR spine · 2025Article
- Mixtures of PRR Ligands Partly Mimic the Immunomodulatory Response ofStem cells international · 2025Article
- Axial rod slip at the end-of-construct screw in scoliosis surgery: relevance, occurrence and prevention.Spine deformity · 2024Article
- Usability of a novel Hounsfield units measurement procedure to quantify intercorporal bone graft remodeling in patients after posterior lumbar interbody fusion: a case series.Journal of medical case reports · 2024Article
- Interscapular Pain after Anterior Cervical Discectomy and Fusion: Does Zygapophyseal Joints over Distraction Play a Role?Journal of clinical medicine · 2024Article
- Advances in Synthetic Grafts in Spinal Fusion Surgery.International journal of spine surgery · 2023Article
- Osteobiologics and Value-Based Care: Challenges and Opportunities.International journal of spine surgery · 2023Article
- Hypoxia Drives Material-Induced Heterotopic Bone Formation by Enhancing Osteoclastogenesis via M2/Lipid-Loaded Macrophage Axis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
- A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in anJournal of orthopaedics and sports medicine · 2022Article
- Synthetic Bone Graft Materials in Spine Fusion: Current Evidence and Future Trends.International journal of spine surgery · 2021Article
- Use of Therapeutic Pathogen Recognition Receptor Ligands for Osteo-Immunomodulation.Materials (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
designin the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.
objectiveThe aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF). SUMMARY OF BACKGROUND DATA: Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.
methodsThis study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).
resultsThere were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).
conclusionThe results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF. LEVEL OF EVIDENCE: 1.
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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.