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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Resport Clinic, MD PhD
- Numéro de téléphone: +34 93 2778709
- E-mail: abat@resportclinic.com
Lieux d'étude
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A Coruña, Espagne, 15009
- Recrutement
- Instituto Médico Arriaza
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Contact:
- Dr Rafael Arriaza, MD
- Numéro de téléphone: +34 981 113 030
- E-mail: info@arriaza.es
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Barcelona, Espagne, 08023
- Recrutement
- Instituto Cugat
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Contact:
- Dr Ramón Cugat, MD PhD
- Numéro de téléphone: +34 938 34 64 50
- E-mail: info@institutocugat.com
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Barcelona, Espagne, 08029
- Recrutement
- ReSport Clinic
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Contact:
- Dr Ferran Abat, MD PhD
- Numéro de téléphone: +34 932 77 87 09
- E-mail: abat@resportclinic.com
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Madrid, Espagne, 28010
- Recrutement
- Ripoll y dePrado Medical Group
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Contact:
- Dra Patricia Núñez, MD
- Numéro de téléphone: +34 91 457 78 02
- E-mail: madrid@ripollydeprado.com
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Vitoria-Gasteiz, Espagne, 01010
- Recrutement
- Hospital MIKS
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Contact:
- Dr Mikel Sanchez, MD PhD
- E-mail: pacientes@hospitalmiks.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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 |
|
Achilles tendinopathy
Achilles tendinopathy treated with 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
|
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
|
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Visual Analog Scale
Délai: From baseline up to 12 months post-treatment
|
From baseline up to 12 months post-treatment
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VISA-P
Délai: 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.
|
baseline, 1 month, 3 months, 6 months and 12 months
|
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VISA-A
Délai: 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).
|
baseline, 1 month, 3 months, 6 months and 12 months
|
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Patient Rated Tennis Elbow Evaluation Scale
Délai: 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
|
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Foot Function Index
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Predictive factors of response to PRP treatment
Délai: baseline
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Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
|
baseline
|
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Adverse events
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ferran Abat Gonzalez, MD PhD, ReSport Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RWE-TDP-20251206
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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