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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 product

    PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Change between baseline and 12 months

Secondary outcomes

1

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

Time frame
Changes between baseline and 2-, 6- 12 and 24-month assessments
2

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.

Time frame
Changes between baseline and 2-, 6- 12 and 24-month assessments
3

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.

Time frame
Changes between baseline and 2-, 6- 12 and 24-month assessments
4

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.

Time frame
Changes between baseline and 2-, 6- 12 and 24-month assessments

Other outcomes

Sponsors and contacts

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