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

January 13, 2021 updated by: Istituto Ortopedico Galeazzi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study 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;

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tegner Activity Scale
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
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
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.
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
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.
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
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.
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
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.
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
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.
Changes between baseline and 2-, 6- 12 and 24-month assessments
Change in Lysholm Knee Score for 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).
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
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).
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
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).
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
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).
Changes between baseline and 2-, 6- 12 and 24-month assessments
Platelet count in Platelet-rich Plasma (PRP)
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
Baseline only
Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics
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
Baseline only
Change in Visual Analog Scale
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.
Changes between baseline and 2-, 6- and 24-month assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Laura De Girolamo, Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Anticipated)

May 30, 2030

Study Completion (Anticipated)

May 30, 2030

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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