Patellar Tendinopathy, Achilles Tendinopathy (AT), Epicondylitis, Lateral, Plantar Fasciitis, Chronic
Conditions
Keywords
tendinopathy, Real World Evidence (RWE), platelet-rich plasma, plantar fasciosis, epicondylitis, patellar tendon, Achilles tendon
Brief summary
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.
Interventions
BIOLOGICALPlatelet rich plasma (PRP)
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
Sponsors
ReSport Clinic
BioSmartData
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Complete blood count showing a platelet concentration \<100 × 10⁹/L (to exclude patients with potential thrombocytopenia) * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | From baseline up to 12 months post-treatment | — |
| VISA-P | baseline, 1 month, 3 months, 6 months and 12 months | 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 | baseline, 1 month, 3 months, 6 months and 12 months | 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 | baseline, 1 month, 3 months, 6 months and 12 months | 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. |
| Foot Function Index | baseline, 1 month, 3 months, 6 months and 12 months | The Foot Function Index (FFI) is a 23-item, self-administered questionnaire designed to measure the impact of foot pathology on function, assessing pain, disability, and activity limitation. It uses a 0-10 Likert scale for items within three subscales, with higher total percentages (0-100%) indicating greater, more severe pain and dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive factors of response to PRP treatment | baseline | Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence |
| Adverse events | 1 month, 3 months, 6 months, 12 months | Assess the incidence of local or systemic adverse events following PRP administration |
Countries
Spain
Contacts
CONTACTResport Clinic, MD PhD
PRINCIPAL_INVESTIGATORFerran Abat Gonzalez, MD PhD
ReSport Clinic
Outcome results
None listed