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

Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

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.

Study Overview

• Status: Recruiting
• Conditions: Epicondylitis, Lateral; Patellar Tendinopathy; Plantar Fasciitis, Chronic; Achilles Tendinopathy (AT)
• Intervention / Treatment: Biological: Platelet rich plasma (PRP)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Resport Clinic, MD PhD; Phone Number: +34 93 2778709; Email: abat@resportclinic.com

Study Locations

• Spain
  • A Coruña, Spain, 15009
    • Recruiting
    • Instituto Médico Arriaza
    • Contact: Dr Rafael Arriaza, MD; Phone Number: +34 981 113 030; Email: info@arriaza.es
  • Barcelona, Spain, 08023
    • Recruiting
    • Instituto Cugat
    • Contact: Dr Ramón Cugat, MD PhD; Phone Number: +34 938 34 64 50; Email: info@institutocugat.com
  • Barcelona, Spain, 08029
    • Recruiting
    • ReSport Clinic
    • Contact: Dr Ferran Abat, MD PhD; Phone Number: +34 932 77 87 09; Email: abat@resportclinic.com
  • Madrid, Spain, 28010
    • Recruiting
    • Ripoll y dePrado Medical Group
    • Contact: Dra Patricia Núñez, MD; Phone Number: +34 91 457 78 02; Email: madrid@ripollydeprado.com
  • Vitoria-Gasteiz, Spain, 01010
    • Recruiting
    • Hospital MIKS
    • Contact: Dr Mikel Sanchez, MD PhD; Email: pacientes@hospitalmiks.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patellar tendinopathy; Patellar tendinopathy treated with PRP	Biological: Platelet 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
Achilles tendinopathy; Achilles tendinopathy treated with PRP	Biological: Platelet 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
Plantar fasciosis; Plantar fasciosis treated with PRP	Biological: Platelet 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
Chronic epycondylitis; Chronic epycondylitis treated with PRP	Biological: Platelet 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale		From baseline up to 12 months post-treatment
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.	baseline, 1 month, 3 months, 6 months and 12 months
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).	baseline, 1 month, 3 months, 6 months and 12 months
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.	baseline, 1 month, 3 months, 6 months and 12 months
Foot Function Index	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.	baseline, 1 month, 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors of response to PRP treatment	Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence	baseline
Adverse events	Assess the incidence of local or systemic adverse events following PRP administration	1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: ReSport Clinic
• Collaborators: BioSmartData
• Investigators: Principal Investigator: Ferran Abat Gonzalez, MD PhD, ReSport Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: tendinopathy, Real World Evidence (RWE), platelet-rich plasma, plantar fasciosis, epicondylitis, patellar tendon, Achilles tendon
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Foot Diseases; Arm Injuries; Fasciitis; Tendinopathy; Fasciitis, Plantar; Tennis Elbow
• Other Study ID Numbers: RWE-TDP-20251206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No