Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments With Orthobiologics

Study Overview
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Brief Summary
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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.

Official Title
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Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments With Orthobiologics

Conditions
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Musculoskeletal System Disease

Intervention / Treatment
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* Combination Product: PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: age < 6 years patients not compliant with post-treatment monitoring procedures pregnancy

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices|PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale | 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. | Change between baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tegner Activity Scale | Level of activity will be recorded using Tegner activity scale (0-10, where 0 represents absence of physical activity and 10 represents national level sport activity) before and after treatment | Changes between baseline and 2-, 6- 12 and 24-month assessments | 
| Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis | The level of symptoms, pain, activity, sport and quality of life will be assessed using Knee injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst outcome and 100 the best outcome) before and after treatment. | Changes between baseline and 2-, 6- 12 and 24-month assessments | 
| Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis | The level of symptoms, pain, activity, sport and quality of life will be assessed using Hip injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst condition and 100 the best condition) before and after treatment. | 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 | The level of symptoms, pain, activity, sport and quality of life will be assessed using Hip injury and Osteoarthritis Outcome Score (0-100, where 0 represents the worst condition and 100 the best condition) before and after treatment. | 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 | Pain level and extent of difficulty with the activity of daily living will be assessed using SPADI (0-100, where 100 represents the worst condition and 0 the best condition) in patients affected by shoulder disorders. | 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 | Symptoms, ability to perform daily and sport activities will be measured using VISA-P score (0-100, where 0 represents the worst condition and 100 the best condition) in patients affected by patellar 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 | Lysholm knee score will be used to assess the condition of the knee in patients affected by patellar tendon disorders (0-100, where 0 represents the worst condition and 100 the best condition). | 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 | Pain, Disability, and Activity Limitation in patients affected by foot and ankle disorders will be measured using FFI (0-100, where 100 represents the worst condition and 0 the best condition). | 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 | Symptoms, ability to perform daily and sport activities will be measured in patients affected by Achilles tendon disorders using VISA-A score (0-100, where 0 represents the worst condition and 100 the best condition). | 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 | Pain and function will be measured in patients affected by elbow disorders using PRTEE score (0-100, where 100 represents the worst condition and 0 the best condition). | Changes between baseline and 2-, 6- 12 and 24-month assessments | 
| Platelet count in Platelet-rich Plasma (PRP) | For each patient receiving PRP, platelet count will be measured in order to evaluate possible correlation between the product composition and the clinical outcomes | Baseline only | 
| Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics | For each patient receiving adipose tissue- or bone marrow-derived orthobiologics, the number of nucleated cells will be determined to evaluate possible correlation between the product composition and the clinical outcomes | Baseline only | 
| Change in Visual Analog Scale | 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. | Changes between baseline and 2-, 6- and 24-month assessments |