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

23. april 2026 opdateret af: ReSport Clinic

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
      • A Coruña, Spanien, 15009
        • Rekruttering
        • Instituto Médico Arriaza
        • Kontakt:
          • Dr Rafael Arriaza, MD
          • Telefonnummer: +34 981 113 030
          • E-mail: info@arriaza.es
      • Barcelona, Spanien, 08023
        • Rekruttering
        • Instituto Cugat
        • Kontakt:
      • Barcelona, Spanien, 08029
        • Rekruttering
        • ReSport Clinic
        • Kontakt:
      • Madrid, Spanien, 28010
        • Rekruttering
        • Ripoll y dePrado Medical Group
        • Kontakt:
      • Vitoria-Gasteiz, Spanien, 01010

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patellar tendinopathy
Patellar tendinopathy treated with PRP
Biologisk: 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
Biologisk: 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
Biologisk: 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
Biologisk: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analog Scale
Tidsramme: From baseline up to 12 months post-treatment
From baseline up to 12 months post-treatment
VISA-P
Tidsramme: 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.
baseline, 1 month, 3 months, 6 months and 12 months
VISA-A
Tidsramme: 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).
baseline, 1 month, 3 months, 6 months and 12 months
Patient Rated Tennis Elbow Evaluation Scale
Tidsramme: 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.
baseline, 1 month, 3 months, 6 months and 12 months
Foot Function Index
Tidsramme: 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.
baseline, 1 month, 3 months, 6 months and 12 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ReSport Clinic

Samarbejdspartnere

BioSmartData

Efterforskere

  • Ledende efterforsker: Ferran Abat Gonzalez, MD PhD, ReSport Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RWE-TDP-20251206

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Epikondylitis, lateral

Kliniske forsøg med Platelet rich plasma (PRP)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner