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

2026年8月3日 更新者：Stefano Zaffagnini

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.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 意大利
    • Bologna
      • Bologna、Bologna、意大利、40136
        • IRCCS Rizzoli Orthopedic Institute
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Subjects will be recruited among patients admitted to the IRCCS Istituto Ortopedico Rizzoli and scheduled for total knee arthroplasty for the treatment of chondral defects and/or undergoing regenerative infiltrative therapies with BMC and PRP.

For the study, biological material obtained during the surgical removal of femoral condyles, tibial plateaus and synovial membranes, as well as during implantation of the prosthetic components, will be used. For BMC and PRP, only waste material not required for the surgical procedures will be collected.

The recovery of such material will be performed during routine clinical practice by the medical staff of the Orthopaedic and Trauma Clinic II.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cellular health parameters
大体时间：72 hours
Cellular health parameters were assessed after 72 hours of exposure to the materials and compared with standardized control samples
72 hours

次要结果测量

结果测量
措施说明
大体时间
Pro-inflammatory cytokines
大体时间：48 hours
Levels of pro-inflammatory cytokines were measured after 6, 24 and 48 hours of exposure to the materials
48 hours
ROS
大体时间：48 hours
Markers of oxidative stress were evaluated after 72 hours of exposure to the materials
48 hours
Osteogenic potential
大体时间：28 days
Osteogenic potential was assessed by evaluating the gene expression of specific osteogenic markers and the production of protein biomarkers (ALP and P1NP) at 7, 14, and 28 days
28 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stefano Zaffagnini

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • RAISE

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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