NCT04711551招募中不适用
Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年5月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Scale
研究概览
简要总结
the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study.
patients who undergo regenerative medicine treatments present acute and chronic pathologies of the musculoskeletal system, of the stomatological system and of the integuments.
Objective pre, peri and post treatment evaluations are collected. A dedicated software collects the PROMs compiled by the patients, the objective clinical data and the biomolecular evaluations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;
- •males and females;
- •age >= 6 years.
排除标准
- •age < 6 years
- •patients not compliant with post-treatment monitoring procedures
- •pregnancy
结局指标
主要结局
Change in Visual Analog Scale
时间窗: Change between baseline and 12 months
Pain will be measured with Visual Analog Scale (0-10, where 0 rapresents absence of pain and 10 the maximum pain possible) before and after treatment.
次要结局
- Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in Victorian Institute of Sport Assessment for Patellar tendon (VISA-P) score for patients affected by patellar tendon disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics(Baseline only)
- Change in Tegner Activity Scale(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in Foot Function Index (FFI) for patients affected by ankle and foot disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in Victorian Institute of Sport Assessment for Achilles tendon (VISA-A) score for patients affected by Achilles tendon disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in Lysholm Knee Score for patients affected by patellar tendon disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Platelet count in Platelet-rich Plasma (PRP)(Baseline only)
- Change in Visual Analog Scale(Changes between baseline and 2-, 6- and 24-month assessments)
- Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SPADI (Shoulder Pain and Disability Index ) questionnaire for patients affected by shoulder disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in the Shoulder Pain and Disability Index (SPADI) for patients affected by shoulder disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
- Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) scale for patients affected by elbow disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
研究者
研究点 (2)
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