Biological Evaluation of Orthopedic Materials: An In Vitro Study Using Patient-Derived Human Samples
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cellular health parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PTG
Subjects eligible among patients scheduled for primary total knee arthroplasty, in whom harvesting of the tibial plateau and/or femoral condyles and/or synovial tissue is planned
BMC
Concentrated bone marrow samples
PRP
Platelet-rich plasma samples
结局指标
主要结局
Cellular health parameters
时间窗: 72 hours
Cellular health parameters were assessed after 72 hours of exposure to the materials and compared with standardized control samples
次要结局
- Pro-inflammatory cytokines(48 hours)
- ROS(48 hours)
- Osteogenic potential(28 days)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli