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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Platelet rich plasma (PRP)
Biological/VaccineA 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
Trial outcomes
Primary outcomes
Visual Analog Scale
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.
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).
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.
Secondary outcomes
Predictive factors of response to PRP treatment
Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
Adverse events
Assess the incidence of local or systemic adverse events following PRP administration
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ReSport Clinic
Lead sponsor
BioSmartData
Collaborator