Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Identification of nutritional status of responder and non-responder patients: cholesterol
研究概览
简要总结
Given the close correlation reported in the literature between onset and progression of tendon pathology in subjects affected by the alteration of metabolic disorders such as obesity, diabetes mellitus and lipidic metabolic alterations, with the present study the association between the nutritional state, metabolic profile and clinical outcome of patients following treatment with blood-derived orthobiological for shoulder tendinopathies will be evaluated.
The primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with "Platelet rich growth factors" PRGF at six months follow up and the correlation with their nutritional status.
详细描述
This is a single-center, observational study with an additional procedure (extra blood sampling routine, food questionnaires, anthropometric measurements for the evaluation of nutritional status), prospective, uncontrolled.
Male and female patients, between 18 and 70 years old suffering from tendinopathy of the shoulder who undergo conservative regenerative medicine procedures with autologous PRGF material at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants in the observational study "Use of Patient- Reported Outcome Measures (PROMs), objective clinical assessments and biomolecular technologies for monitoring patients undergoing treatments regenerative medicine" [REGAIN] will be enrolled for this study.
46 patients will be needed:
- 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF;
- 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI>25, who undergo the PRGF treatment.
The general aim of the present study is to evaluate the correlation between the nutritional status of patients, the characteristics of the orthobiological product used for the treatment of shoulder tendon pathology and clinical outcomes after one-step conservative regenerative medicine treatment with PRGF in order to identify the ideal nutritional conditions to obtain the best clinical outcome from this type of treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •Age ≥18 years and ≤ 70 years
- •Patients presenting shoulder tendinopathy
- •Signing of the Informed Consent of the Regain observational study
- •Signature of informed consent of the present study.
排除标准
- •Pregnancy (ascertained by self-declaration), breastfeeding
- •Inability to follow the study protocol
- •Heart, kidney, oncological disease
- •Neuropsychiatric disease
- •Other conditions that, at the discretion of the investigator or physician, exclude enrollement
结局指标
主要结局
Identification of nutritional status of responder and non-responder patients: cholesterol
时间窗: 0-24 months
Cholesterol (mg/dl)
Identification of nutritional status of responder and non-responder patients: calcium
时间窗: 0-24 months
Calcium: mg/dl
Identification of nutritional status of responder and non-responder patients: vitamin B 12
时间窗: 0-24 months
Vitamin B 12 (pg/ml)
Anthropometric measurement: height
时间窗: 0-24 months
height (m) measurement
Anthropometric measurement: subscapular folds measurement
时间窗: 0-24 months
subscapular folds measurement (mm)
Anthropometric measurement: suprailiac folds measurement
时间窗: 0-24 months
suprailiac folds measurement (mm)
Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase
时间窗: 0-24 months
Glutamate-oxaloacetate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH)
时间窗: 0-24 months
Vitamin D (25 OH): ng/ml
Anthropometric measurement: weight
时间窗: 0-24 months
weight (kg) measurement
Anthropometric measurement: biceps folds measurement
时间窗: 0-24 months
biceps folds measurement (mm)
Identification of nutritional status of responder and non-responder patients: blood glucose
时间窗: 0-24 months
Blood glucose (mg/dl)
Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c)
时间窗: 0-24 months
Hemoglobin A1C (HbA1c): mmol/mol
Identification of nutritional status of responder and non-responder patients: creatinine
时间窗: 0-24 months
Creatinine: mg/dl
Identification of nutritional status of responder and non-responder patients: siderosis
时间窗: 0-24 months
siderosis: ug/dl
Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase
时间窗: 0-24 months
Glutamate-pyruvate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: gamma GT
时间窗: 0-24 months
Gamma GT: U/l
Identification of nutritional status of responder and non-responder patients: ferritin
时间窗: 0-24 months
Ferritin (ng/ml)
Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH)
时间窗: 0-24 months
thyroid stimulating hormone (TSH): uIU/ml
Identification of nutritional status of responder and non-responder patients: Folates
时间窗: 0-24 months
Folates (ng/ml)
Anthropometric measurement: waist circumference
时间窗: 0-24 months
waist circumference (cm) measurement
Anthropometric measurement: triceps folds measurement
时间窗: 0-24 months
triceps folds measurement (mm)
Identification of nutritional status of responder and non-responder patients: tryglicerides
时间窗: 0-24 months
tryglicerides (mg/dl)
Identification of nutritional status of responder and non-responder patients: Cholesterol HDL
时间窗: 0-24 months
Cholesterol HDL (mg/dl)
Identification of nutritional status of responder and non-responder patients: complete blood count
时间窗: 0-24 months
Complete blood count (cell number/dl)
Responder and non-responder patient identification at 6 months follow-up.
时间窗: 0-24 months
The primary objective of this study is to identify the proportion of responder and non-responder patients with shoulder tendinopathy to treatment with orthobiological "Platelet rich growth factors" PRGF at six month follow up. Responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI, WOOS scores, and Work index.
Identification of nutritional status of responder and non-responder patients: Insulin
时间窗: 0-24 months
Insulin: uU/ml
Anthropometric measurement: arm circumference measurements
时间窗: 0-24 months
arm circumference measurements (cm)
Identification of nutritional status of responder and non-responder patients: urea
时间窗: 0-24 months
Urea: mg/dl
Identification of nutritional status of responder and non-responder patients:
时间窗: 0-24 months
C reactive protein: (mg/dl)
次要结局
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin(24-26 months)
- The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification(24-26 months)
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin(24-26 months)
- Responder and non-responder patient identification at 2 months follow-up.(2-26 months)
- The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count(24-26 months)
- Responder and non-responder patient identification at 12 months follow-up.(12-36 months)
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8(24-26 months)
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF(24-26 months)