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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Resport Clinic, MD PhD
- Numero di telefono: +34 93 2778709
- Email: abat@resportclinic.com
Luoghi di studio
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A Coruña, Spagna, 15009
- Reclutamento
- Instituto Médico Arriaza
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Contatto:
- Dr Rafael Arriaza, MD
- Numero di telefono: +34 981 113 030
- Email: info@arriaza.es
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Barcelona, Spagna, 08023
- Reclutamento
- Instituto Cugat
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Contatto:
- Dr Ramón Cugat, MD PhD
- Numero di telefono: +34 938 34 64 50
- Email: info@institutocugat.com
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Barcelona, Spagna, 08029
- Reclutamento
- ReSport Clinic
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Contatto:
- Dr Ferran Abat, MD PhD
- Numero di telefono: +34 932 77 87 09
- Email: abat@resportclinic.com
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Madrid, Spagna, 28010
- Reclutamento
- Ripoll y dePrado Medical Group
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Contatto:
- Dra Patricia Núñez, MD
- Numero di telefono: +34 91 457 78 02
- Email: madrid@ripollydeprado.com
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Vitoria-Gasteiz, Spagna, 01010
- Reclutamento
- Hospital MIKS
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Contatto:
- Dr Mikel Sanchez, MD PhD
- Email: pacientes@hospitalmiks.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Patellar tendinopathy
Patellar tendinopathy treated with PRP
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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 |
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Achilles tendinopathy
Achilles tendinopathy treated with PRP
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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 |
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Plantar fasciosis
Plantar fasciosis treated with PRP
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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 |
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Chronic epycondylitis
Chronic epycondylitis treated with PRP
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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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Visual Analog Scale
Lasso di tempo: From baseline up to 12 months post-treatment
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From baseline up to 12 months post-treatment
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VISA-P
Lasso di tempo: baseline, 1 month, 3 months, 6 months and 12 months
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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.
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baseline, 1 month, 3 months, 6 months and 12 months
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VISA-A
Lasso di tempo: baseline, 1 month, 3 months, 6 months and 12 months
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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).
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baseline, 1 month, 3 months, 6 months and 12 months
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Patient Rated Tennis Elbow Evaluation Scale
Lasso di tempo: baseline, 1 month, 3 months, 6 months and 12 months
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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.
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baseline, 1 month, 3 months, 6 months and 12 months
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Foot Function Index
Lasso di tempo: baseline, 1 month, 3 months, 6 months and 12 months
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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.
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baseline, 1 month, 3 months, 6 months and 12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Predictive factors of response to PRP treatment
Lasso di tempo: baseline
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Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
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baseline
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Adverse events
Lasso di tempo: 1 month, 3 months, 6 months, 12 months
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Assess the incidence of local or systemic adverse events following PRP administration
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1 month, 3 months, 6 months, 12 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ferran Abat Gonzalez, MD PhD, ReSport Clinic
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RWE-TDP-20251206
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Prove cliniche su Platelet rich plasma (PRP)
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University of California, San DiegoReclutamentoArtrite al ginocchioStati Uniti