Evidence map›Paper›PMID 41201060›Full record

ArticleBone & joint research2025

Biomimetic tri-layered osteochondral scaffold : study of early implant stability in a sheep model.

Manuela Salerno, Alessandro Di Martino, Elisabetta Galassi, Laura Grillini, Alessandro Dotti, Claudio De Luca, Giuseppe Filardo

Abstract read
In one paragraph

Article in Bone & joint research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Manuela SalernoApplied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Alessandro Di MartinoApplied and Translational Research Center, Clinica Ortopedica e Traumatologica, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Elisabetta GalassiFin-Ceramica Faenza S.p.a., Faenza, Italy.
Laura GrilliniFin-Ceramica Faenza S.p.a., Faenza, Italy.
Alessandro DottiFin-Ceramica Faenza S.p.a., Faenza, Italy.
Claudio De LucaFin-Ceramica Faenza S.p.a., Faenza, Italy.
Giuseppe FilardoService of Orthopaedics and Traumatology, Department of Surgery, EOC, Lugano, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aims: The aim of this study was to investigate a biomimetic biodegradable cell-free osteochondral scaffold in a clinically relevant large animal model to quantify the early integration and regeneration phases after implantation. Methods: Bilateral critical-sized osteochondral defects were created in 14 sheep. One defect was filled with the scaffold, whereas the contralateral was left empty. The graft integration and regeneration tissue quality were evaluated at 14 and 30 days of follow-up. In particular, samples were evaluated for inflammation grade according to the ISO 10993-6 international standard biological evaluation of medical devices, macroscopic appearance graded according to a modified Fortier et al scoring system, histological quality according to a modified International Cartilage Repair Society (ICRS) II score, and the new trabecular bone formation with a micro-CT analysis. Results: At 14 days, a higher defect filling was found in the scaffold group compared to the control in the gross analysis (p < 0.001). Low inflammation was observed in both groups, with a slight increase in the scaffold group at 30 days. The scaffold group had better histological scores, with a significantly higher mean global ICRS II score at 30 days compared to controls (p = 0.031). Finally, the mean percentage of new trabecular bone (BV/TV) was significantly higher in the scaffold group versus the control group, both at 14 days (11.5% (SD 4.5) and 5.2% (SD 2.3), respectively; p = 0.005) and at 30 days (28.0% (SD 8.1) and 8.8% (SD 5.0), respectively; p = 0.002). Conclusion: The tri-layered biomaterial showed good integration with surrounding tissues and new tissue growth promotion after 14 and 30 days post-surgery, with no safety concerns. In light of the development of appropriate postoperative rehabilitation programmes to prevent the risk of early implant failure while avoiding delays and providing a proper recovery path, this study provides support for the new cartilage field trend for this osteochondral scaffold, suggesting the possibility of safely shortening the postoperative rehabilitation phase after surgery.

Identifiers

PMID41201060
PMCPMC12593967

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.