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

Recruiting

• Conditions: Musculoskeletal System Disease

• Registration Number: NCT04711551
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-30
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2030-05-30
• Study Completion: 2030-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis	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.
Change in Victorian Institute of Sport Assessment for Patellar tendon (VISA-P) score for patients affected by patellar tendon disorders	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.
Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics	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
Change in Tegner Activity Scale	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
Change in Foot Function Index (FFI) for patients affected by ankle and foot disorders	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).
Change in Victorian Institute of Sport Assessment for Achilles tendon (VISA-A) score for patients affected by Achilles tendon disorders	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).
Change in Lysholm Knee Score for patients affected by patellar tendon disorders	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).
Platelet count in Platelet-rich Plasma (PRP)	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
Change in Visual Analog Scale	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.
Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis	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.
Change in QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SPADI (Shoulder Pain and Disability Index ) questionnaire for patients affected by shoulder disorders	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.
Change in the Shoulder Pain and Disability Index (SPADI) for patients affected by shoulder disorders	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.
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) scale for patients affected by elbow disorders	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).

Trial Locations

Locations (2)

Istituto Clinico San Siro (satellite center); 🇮🇹 Milano, Italia, Italy

IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator); 🇮🇹 Milan, Italy