About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
age < 6 years
patients not compliant with post-treatment monitoring procedures
pregnancy
Trial population
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;
Trial design
Cohort
Other
Treatments tested in this trial
PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
Combination productPRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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.
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.
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.
Sponsors and contacts
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