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

NCT07671521 · tracked via the Priya Life Science Italy tracker

Sponsor

Stefano Zaffagnini

Phase

Observational

Started

2026-09

Last updated

2026-08-04

Condition(s) studied

Cytotoxicity

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Femoral condyle, tibial plateau and synovial membrane samples Patients undergoing primary total knee arthroplasty at the Orthopaedic and Trauma Clinic II of the IRCCS Istituto Ortopedico Rizzoli (Bologna, Italy), in whom collection of tibial plateau, femoral condyles and/or synovial tissue is planned. Inclusion criteria: Age 18-80 years, male or female Primary tricompartmental osteoarthritis Body Mass Index (BMI) \< 35 Kellgren-Lawrence grade III-IV osteoarthritis Written informed consent Exclusion criteria: Previous partial knee arthroplasty or cartilage repair/regenerative procedures Rheumatoid arthritis or chronic corticosteroid/immunosuppressive therapy Positive testing for HIV, HBV or HCV infection Concentrated bone marrow (BMC) samples Patients of both sexes providing written informed consent and presenting with the following characteristics: Inclusion criteria: Age 18-70 years Medial compartment knee osteoarthritis (Kellgren-Lawrence grade II-III for \>4 months) Failure of ≥6 months of conservative treatment (NSAIDs/analgesics, hyaluronic acid, corticosteroid or PRP injections) Written informed consent Exclusion criteria: Inability to provide informed consent Knee trauma within the previous 6 months Malignancy, rheumatic disease, uncontrolled diabetes, uncontrolled thyroid disorders Alcohol or drug abuse BMI \> 35 Intra-articular injections within the previous 6 months Knee surgery within the previous 12 months HIV, HBV or HCV positivity Platelet-rich plasma (PRP) samples Patients of both sexes with degenerative cartilage disease of the knee. Inclusion criteria: Age 18-65 years Clinical signs and symptoms of knee cartilage degeneration Radiographic or MRI evidence of degeneration (Kellgren-Lawrence grade II-IV) Hemoglobin \> 11 g/dL Platelet count \> 150,000/mm³ No clinically relevant ECG abnormalities Written informed consent Exclusion criteria: Rheumatoid arthritis or chronic corticosteroid/immunosuppressive therapy Uncontrolled diabetes Hematological disorders or anticoagulant/antiplatelet therapy Thyroid metabolic disorders Alcohol, drug or medication abuse NSAID use within 3 days prior to blood draw Cardiovascular disease contraindicating a 150 mL blood draw HIV, HBV or HCV positivity

Primary outcome measure(s)

Cellular health parameters — 72 hours
Cellular health parameters were assessed after 72 hours of exposure to the materials and compared with standardized control samples

Trial sites (1)

Facility	City	Region	Status
IRCCS Rizzoli Orthopedic Institute	Bologna	Bologna

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07671521 on ClinicalTrials.gov ↗ ← All trials in Italy