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临床试验/NCT06490770
NCT06490770
招募中
不适用

Analysis of the Pathophysiological and Functional State of the Knee Joint

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 25 人2025年7月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Osteoarthritis, Knee
发起方
Istituto Ortopedico Rizzoli
入组人数
25
试验地点
1
主要终点
Magnetic Resonance Imaging
状态
招募中
最后更新
9个月前

概览

简要总结

Osteoarthritis is the most common degenerative condition affecting the knee joint globally, with an incidence of about 7% of the population. In Italy, it affects approximately 3.9 million people, with a direct treatment cost of around €2.5 billion. At the joint level, osteoarthritis manifests with pain and reduced functionality, worsening as the disease progresses and severely limiting knee movement. Compounding this, osteoarthritis can impact both elderly and younger individuals due to traumatic factors.

Despite its significant impact, effective treatments for osteoarthritis that address its underlying causes are still lacking, focusing mainly on symptom management. Therefore, improving diagnostic and prognostic approaches is crucial to better understand its onset and progression.

MRI is a primary diagnostic tool for assessing the knee joint's pathophysiological state. It uses tissue-specific sequences to investigate joint homeostasis in detail, although it primarily provides insights into morphology, structure, and tissue composition rather than functional changes within the joint. This limitation is noteworthy because joint homeostasis involves complex interactions among biomechanical, structural, and biological processes, which are directly influenced by osteoarthritis.

Gait analysis provides valuable diagnostic information on joint function. By integrating sensor measurements and electronic systems with patient-specific musculoskeletal models derived from MRI morphometric data, it is possible to assess the forces and moments within the joint during specific movements.

Given that osteoarthritis affects the entire joint, employing multidisciplinary approaches can enhance diagnostic precision and provide insights into the progressive impact of degenerative conditions like osteoarthritis on joint health.

注册库
clinicaltrials.gov
开始日期
2025年7月9日
结束日期
2027年4月1日
最后更新
9个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

入排标准

入选标准

  • Knee pain and/or loss of functionality
  • Kellgren-Lawrence grade less than or equal to 2
  • Arthroscopic evidence of cartilage tissue lesions
  • Evidence of cartilage and/or meniscal tissue degeneration and/or subchondral bone marrow lesions

排除标准

  • History/evidence of previous partial or total knee prosthesis interventions
  • Inability to provide informed consent
  • Conditions or physical disorders incompatible with the use of MRI and electrical stimulation (implanted active and passive biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)

结局指标

主要结局

Magnetic Resonance Imaging

时间窗: at baseline and 12-month follow-up

MRI images will be acquired for each subject using a high-field scanner (3T, Discovery MR750w3, GE Healthcare, UK) with sequences that will allow i) the analysis of the pathophysiological state of the knee cartilage, and ii) the identification and segmentation of the various leg muscles. Regarding the investigation of joint tissues, quantitative sequences (e.g., T2 mapping) will be acquired using a specific coil, according to standard practice. MRI images related to the muscular aspects of the entire lower limb will be added to the previous ones-which will instead be focused on the region bounded by the femoral and tibial diaphyses-in order to obtain complete information in a single acquisition session with additional timing on the order of minutes. MRI images at the 12-month follow-up are specific to the study.

次要结局

  • Gait Analysis (including Electromyography)(at baseline and 12-month follow-up)
  • Clinical questionnaires(at baseline and 12-month follow-up)
  • Strength measurements with a manual dynamometer(at baseline and 12-month follow-up)
  • Bioimpedance analysis(at baseline and 12-month follow-up)

研究点 (1)

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