ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2026
The ISSLS VERTEBRA initiative: establishing reporting standards for regenerative medicine trials in disc degeneration and low back pain.
Article in 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, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRegenerative medicine (RM) trials for intervertebral disc degeneration (IDD) are gaining increasing visibility and clinical relevance, yet reporting quality remains inconsistent and often incomplete. Critical details on trial methodology, biologic product specifications, imaging criteria, and outcome assessment are frequently insufficiently reported, limiting reproducibility and hindering the interpretation of available evidence. The aim of this study was to develop a spine-specific reporting guideline to support authors, reviewers, and readers in producing transparent and interpretable RM clinical trial reports.
methodsA three-stage process was undertaken to establish a consensus-based reporting guideline. First, a systematic review of published RM trials employing intradiscal biologic treatments was conducted to identify recurring reporting deficiencies. Second, an expert focus group and subsequent international survey hosted by the International Society for the Study of the Lumbar Spine (ISSLS) generated and prioritized candidate reporting items. Third, the finalized VERTEBRA checklist was applied to an updated cohort of clinical trials to evaluate reporting completeness across predefined domains.
resultsAcross 36 eligible clinical trials, the mean VERTEBRA completeness score was 53.8%, with substantial variability among studies. Recurrent deficiencies were consistently observed in product characterization, methodological transparency, imaging acquisition and analysis, baseline reporting, and management of missing data. Only a minority of studies referenced established reporting guidelines. Reporting quality showed an association with journal impact factor, but not geographic region or funding disclosures. Expert polling demonstrated strong agreement on the need for a spine-specific reporting tool, resulting in the development of a 50-item checklist organized across five domains.
conclusionThe VERTEBRA reporting guideline provides a structured, field-specific framework to elevate transparency, reproducibility, and interpretability in RM trials for IDD. Its adoption may enhance manuscript quality, strengthen peer review, and improve the reliability of evidence guiding the development and clinical translation of future regenerative therapies for IDD.
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Identifiers
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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.