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Biological Evaluation of Orthopedic Materials: An In Vitro Study Using Patient-Derived Human Samples

NCT07671521 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-04

No results posted yet for this study

Summary

The anterior cruciate ligament (ACL) is the primary stabilizer of the knee joint, and ACL injuries are highly prevalent, particularly among physically active and athletic individuals. Although ACL reconstruction is a well-established orthopedic procedure, significant challenges remain regarding biological integration between the graft and bone, which may negatively affect clinical outcomes.

In recent years, advanced biomaterials and regenerative medicine approaches have gained increasing attention as potential strategies to enhance osteointegration and promote more physiological tissue healing. Before clinical application, these materials must undergo rigorous in vitro biological evaluation in accordance with international standards, particularly ISO 10993-5 for cytotoxicity assessment.

The study will investigate cytotoxicity, cell viability, inflammatory responses, pro-fibrotic effects, and osteogenic potential using relevant human cell models. The regenerative effects of platelet-rich plasma (PRP), a source of growth factors, will also be evaluated.

The biomaterials under investigation include a titanium alloy and polylactic acid (PLA), both widely used in orthopedic applications. The main objective is to demonstrate their biocompatibility, absence of cytotoxic, inflammatory, and pro-fibrotic effects, and their ability to support osteogenic processes and tissue integration. The findings will provide essential evidence for subsequent preclinical in vivo studies and future clinical translation.

Conditions

  • Cytotoxicity

Sponsors & Collaborators

  • Stefano Zaffagnini

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671521 on ClinicalTrials.gov