Actively Recruiting

Age: 18Years +
All Genders
ID07558564

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

Led by ReSport Clinic · Updated on 2026-04-30

2000

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

R

ReSport Clinic

Lead Sponsor

B

BioSmartData

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter, prospective, observational study to evaluate the effectiveness and safety of Platelet-Rich Plasma (PRP) treatment for four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. The study uses real-world evidence and data collected through the BioSmartData4 platform, including hematology analyzers for detailed PRP characterization, clinical variables, treatment protocols, and ongoing assessment of treatment response. Participants with chronic tendinopathy will receive PRP treatment following standardized protocols documented across centers. Variables such as the type of PRP (leukocyte-rich or leukocyte-poor), preparation method (single or double centrifugation), injected volume, anatomical site, administration technique (preferably ultrasound-guided), number of treatment sessions, and intervals between sessions will be recorded. The study groups include patients treated for patellar tendinopathy, Achilles tendinopathy, plantar fasciosis, and chronic epicondylitis. During the 12-month follow-up, participants will undergo evaluations including pain scales like the Visual Analog Scale and condition-specific disability scores such as VISA-P, VISA-A, Patient Rated Tennis Elbow Evaluation Scale, and Foot Function Index at multiple time points. Researchers will also monitor predictive factors for treatment response and any adverse events. Participants' treatment and progression will be observed in real-world clinical settings from baseline through one year after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical or ultrasound diagnosis of chronic tendinopathy lasting more than 6 weeks
  • Age 18 years or older
  • Written informed consent provided
  • Willingness and ability to complete follow-up assessments for 12 months
Not Eligible

You will not qualify if you...

  • Surgical treatment on the affected tendon within the last 6 months
  • Corticosteroid injection in the affected area within the last month
  • Presence of systemic inflammatory diseases such as rheumatoid arthritis
  • Coagulopathies or ongoing anticoagulant therapy
  • Platelet count less than 100 x 10^9/L on blood test
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for clinical or ultrasound diagnosis and blood test

Treatment

Duration - Variable depending on number of PRP sessions

Participants receive platelet-rich plasma (PRP) injections for their tendinopathy, with details recorded on preparation and administration.

1 to multiple visits for PRP injection sessions depending on treatment plan

Long-term Monitoring

Duration - Up to 12 months

Participants are monitored for treatment effectiveness and adverse events with follow-up assessments up to 12 months post-treatment.

Follow-up visits at 1 month, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 5 locations

1

Instituto Médico Arriaza

A Coruña, Spain, 15009

Actively Recruiting

2

Instituto Cugat

Barcelona, Spain, 08023

Actively Recruiting

3

ReSport Clinic

Barcelona, Spain, 08029

Actively Recruiting

4

Ripoll y dePrado Medical Group

Madrid, Spain, 28010

Actively Recruiting

5

Hospital MIKS

Vitoria-Gasteiz, Spain, 01010

Actively Recruiting

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Research Team

R

Resport Clinic, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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