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| ID | Type | Description | Link |
|---|---|---|---|
| 5xmille 2021CUPC43C2200237000 | Other Grant/Funding Number | Italian Ministry of health | |
| L1054 Ricerca corrente | Other Grant/Funding Number | Italian Ministry of health |
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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.
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:
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.
The primary objective of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at six month follow up and the correlation with their nutritional status. To this end, responsive patients and non-responsive will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI, WOOS scores, and Work index.
The secondary objectives of the study will be:
1) to Identify the proportion of responsive and non-responsive patients presenting shoulder tendinopathy to treatment with orthobiological "Platelet rich growth factors" PRGF at two and twelve months follow up and the correlation with their nutritional status. For this purpose, responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI scores, WOOS, and Work index.
Characterization of the PRGF product used for the treatment of each patient that will occur by qualitative and quantitative analysis of the content in extracellular vesicles, analysis of a panel of cytokines, chemokines and growth factors linked to inflammation and correlated to the state nutritional information of patients (e.g. resistin, P-selectin, interleukins etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight patients | 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF. |
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| Over weight patients | 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI>25, who undergo the PRGF treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich growth factor injection (autologous product) | Biological | All patients will undergo two PRGF injections, one at recruitment and one 14 days after the first injection. The injection site will be the shoulder with tendinopathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder and non-responder patient identification at 6 months follow-up. | 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. | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: complete blood count | Complete blood count (cell number/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: blood glucose | Blood glucose (mg/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c) | Hemoglobin A1C (HbA1c): mmol/mol | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: urea | Urea: mg/dl | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: creatinine | Creatinine: mg/dl | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: siderosis |
| Measure | Description | Time Frame |
|---|---|---|
| Responder and non-responder patient identification at 2 months follow-up. | The secondary objectives of the study will be: to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at two months follow up. For this purpose, responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI scores, WOOS, and Work index. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | VAS: Visual analogue scales for grading of pain. The VAS ranges from 0 (no pain) to 10 (worst pain) ((consists of a 10 cm line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain)) | 2-36 months |
Inclusion Criteria:
Exclusion Criteria:
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Male and female patients, between 18 and 70 years old suffering from shoulder tendinopathy undergoing a conservative regenerative medicine procedure with autologous PRGF at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants at the observational study "Use of patients- Reported Outcome Measures (PROM), 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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola De Luca, PhD | Contact | +39 3921385179 | deluca.paola@grupposandonato.it | |
| Michela Taiana, PhD | Contact | +39 3335952857 | michelamaria.taiana@grupposandonato.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | Recruiting | Milan | 20173 | Italy |
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human blood samples
siderosis: ug/dl
| 0-24 months |
| Identification of nutritional status of responder and non-responder patients: tryglicerides | tryglicerides (mg/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: cholesterol | Cholesterol (mg/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Cholesterol HDL | Cholesterol HDL (mg/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase | Glutamate-oxaloacetate transaminase: (U/l) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase | Glutamate-pyruvate transaminase: (U/l) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: gamma GT | Gamma GT: U/l | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: calcium | Calcium: mg/dl | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH) | Vitamin D (25 OH): ng/ml | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: ferritin | Ferritin (ng/ml) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: | C reactive protein: (mg/dl) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH) | thyroid stimulating hormone (TSH): uIU/ml | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Insulin | Insulin: uU/ml | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: Folates | Folates (ng/ml) | 0-24 months |
| Identification of nutritional status of responder and non-responder patients: vitamin B 12 | Vitamin B 12 (pg/ml) | 0-24 months |
| Anthropometric measurement: weight | weight (kg) measurement | 0-24 months |
| Anthropometric measurement: height | height (m) measurement | 0-24 months |
| Anthropometric measurement: waist circumference | waist circumference (cm) measurement | 0-24 months |
| Anthropometric measurement: arm circumference measurements | arm circumference measurements (cm) | 0-24 months |
| Anthropometric measurement: biceps folds measurement | biceps folds measurement (mm) | 0-24 months |
| Anthropometric measurement: triceps folds measurement | triceps folds measurement (mm) | 0-24 months |
| Anthropometric measurement: subscapular folds measurement | subscapular folds measurement (mm) | 0-24 months |
| Anthropometric measurement: suprailiac folds measurement | suprailiac folds measurement (mm) | 0-24 months |
| 2-26 months |
| Responder and non-responder patient identification at 12 months follow-up. | The secondary objectives of the study will be: to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at twelve months follow up. For this purpose, responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI scores, WOOS, and Work index. | 12-36 months |
| The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count | extracellular vesicles count: number/ml | 24-26 months |
| The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification | Identification of extracellular vesicles markers: Arbitrary Fluorescence Unit | 24-26 months |
| The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8 | Quantitative analysis of cytokines (CXCL8): pg/ml | 24-26 months |
| The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF | Quantitative analysis of growth factors: G-CSF (pg/ml) | 24-26 months |
| The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin | Quantitative analysis of resistin: pg/ml | 24-26 months |
| The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin | Quantitative analysis of P-selectin: pg/ml | 24-26 months |
| ASES SCORE |
ASES (American Shoulder and Elbow Surgeons) Score: ASES score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function |
| 2-36 months |
| Quick Dash Score | Quick Dash (Disabilities of Arm, Shoulder and Hand) score. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. | 2-36 months |
| SPADI scores | SPADI (Shoulder Pain and Disability Index) scores. It evaluates pain and functional activities. Pain scale: 0 = no pain and 10 = the worst pain imaginable. Disability scale: 0 = no difficulty and 10 = so difficult it requires help. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). | 2-36 months |
| WOOS Index | WOOS (Western Ontario Osteoarthritis of the Shoulder) index. 0% is the worst possible result and 100% is the best possible results. | 2-36 months |
| WORC Index | The WORC (Western Ontario Rotator Cuff) Index, is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a RC tendinopathy. Total final WORC scores can, therefore, range from 0% (lowest functional status level) to 100% (the highest functional status) | 2-36 months |