Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReSport Clinic

About this trial

This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterization, clinical variables, treatment protocols, and longitudinal assessment of therapeutic response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical and/or ultrasound diagnosis of chronic tendinopathy (duration >6 weeks)

Age >18 years

Provision of written informed consent

Willingness and ability to complete follow-up assessments for 12 months

Disqualifiers

Surgical treatment of the affected tendon within the previous 6 months

Corticosteroid injection within the last month

Systemic inflammatory disease (e.g., rheumatoid arthritis)

Coagulopathies or ongoing anticoagulant therapy

Trial population

Adult patients (\>18 years), of both sexes, diagnosed with patellar, Achilles, epicondylar tendinopathy or plantar fasciosis, who have received PRP treatment according to physician discretion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Platelet rich plasma (PRP)

    Biological/Vaccine

    A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: Patellar tendinopathy1 intervention
Group B: Achilles tendinopathy1 intervention
Group C: Plantar fasciosis1 intervention
Group D: Chronic epycondylitis1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale

Time frame
From baseline up to 12 months post-treatment
2

VISA-P

Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.

Time frame
baseline, 1 month, 3 months, 6 months and 12 months
3

VISA-A

The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).

Time frame
baseline, 1 month, 3 months, 6 months and 12 months
4

Patient Rated Tennis Elbow Evaluation Scale

The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item self-report questionnaire designed to measure pain and functional disability in patients with lateral epicondylitis (tennis elbow). It includes a 5-item pain subscale and a 10-item function subscale, providing a total score out of 100 to assess, evaluate, and monitor recovery.

Time frame
baseline, 1 month, 3 months, 6 months and 12 months

Secondary outcomes

1

Predictive factors of response to PRP treatment

Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence

Time frame
baseline
2

Adverse events

Assess the incidence of local or systemic adverse events following PRP administration

Time frame
1 month, 3 months, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ReSport Clinic

Lead sponsor

BioSmartData

Collaborator