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 ISSLS VERTEBRA initiative: establishing reporting standards for regenerative medicine trials in disc degeneration and low back pain.
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Schol Jordy, Ambrosio Luca, Ruiz-Fernandez Clara, Sakai Daisuke, Vadalà Gianluca, VERTEBRA Working Group
Аннотация
PURPOSE: Regenerative 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.
METHODS: A 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.
RESULTS: Across 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.
CONCLUSION: The 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.
METHODS: A 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.
RESULTS: Across 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.
CONCLUSION: The 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.