NCT Number: NCT04711551
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.
Interested in participating?
Request Info6 year and older
All sexes
Observational
Istituto Clinico San Siro (satellite center), Milan, Italia, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
Time frame: Change between baseline and 12 months
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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.
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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).
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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).
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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).
Time frame: Changes between baseline and 2-, 6- 12 and 24-month assessments
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).
Time frame: Baseline only
For each patient receiving PRP, platelet count will be measured in order to evaluate possible correlation between the product composition and the clinical outcomes
Time frame: Baseline only
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
Time frame: Changes between baseline and 2-, 6- and 24-month assessments
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.
Contact information is provided by the study sponsor or research team.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Other
Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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