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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 sites in 1 country2,000 target enrollmentMay 30, 2018

ConditionsMusculoskeletal System Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Musculoskeletal System Disease
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment: 2000
Locations: 2
Primary Endpoint: Change in Visual Analog Scale
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 30, 2018

End Date

May 30, 2030

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Visual Analog Scale

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.

Secondary Outcomes

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)
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)
Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics(Baseline only)
Change in Tegner Activity Scale(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(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(Changes between baseline and 2-, 6- 12 and 24-month assessments)
Change in Lysholm Knee Score for patients affected by patellar tendon disorders(Changes between baseline and 2-, 6- 12 and 24-month assessments)
Platelet count in Platelet-rich Plasma (PRP)(Baseline only)
Change in Visual Analog Scale(Changes between baseline and 2-, 6- and 24-month assessments)
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)
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)
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)
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)