Nutrition as a Risk Factor and Predictor of the Outcome of Orthobiological Treatments for Knee Osteoarthritis

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点分布在 1 个国家目标入组 88 人开始时间: 2021年9月29日最近更新: 2022年9月21日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 88
试验地点: 1
主要终点: Identification of the nutritional status of patients: Complete blood count

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The general purpose of this study is to evaluate the relation between the nutritional status of patients, the features of the orthobiologics products used for patients' treatment and the clinical outcomes after one-step conservative regenerative treatment for knee osteoarthritis.

详细描述

The general purpose of this monocentric, observational with additional procedure (extra routine blood sampling, questionnaires and measurement of Nutritional status), prospective and non-controlled study is to evaluate the relation between the nutritional status of patients, the features of the orthobiologics products used for patients' treatment and the clinical outcomes after one-step conservative regenerative treatment (Platelete rich plasma and micro-fragmented adipose tissue injections) for knee osteoarthritis.The primary outcome of the study will be the identification of the proportion of responders and non-responders patients to the orthobiologic treatment (according to OMERACT-OARSI criteria) at 6-month follow-up. Another primary outcome will be the nutritional status identification of the same patients.

For these purposes the responder or non-responder patients will be identified based on the results of the Visual Analogue Scale (VAS) [the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100; a higher score indicates greater pain intensity no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)], Tegner-Lysholm Activity Scale and Knee Injury (Scores range from 0=worse disability to 100=less disability) and Osteoarthritis Outcome score (KOOS) (the score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems) according to the parameters established by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) [they cannot be represented by a range of values]. The secondary outcomes of the study will be:

the identification of the proportion of responders and non-responders patients to the orthobiologic treatment (according to OMERACT-OARSI criteria) at 2 and 12-month follow-up and of their related nutritional status;
the characterization of the orthobiologic products used for the patient's treatment.

After the ethics committee approval, patients meeting the inclusion criteria undergoing conservative knee regenerative medicine treatments with orthobiologics and participating to the observational study "REGAIN" will be enrolled into the study. The PROMs will be completed by patients based on their clinical condition and on the specific treatment they will receive at the REGAIN Center. The aforementioned PROMs include but are not limited to:

VAS, Tegner-Lysholm Activity Scale, KOOS. Patients will be asked to filled the PROMs at the time of the enrollment (before the treatment) and then at 2, 6 and 12 months after the treatment.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•males and females ≥18 and ≤ 65 years;
•presence of knee osteoarthritis;
•indication to regenerative medicine treatments PRP or microfragmented adipose treatment;
•participation to the observational study "REGAIN";
•patients with BMI ≥18.5;
•signature of Informed Consent for the study.

排除标准

•patients with BMI <18.5;
•patients who are not able to comply with the study schedule.