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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Resport Clinic, MD PhD
- Número de teléfono: +34 93 2778709
- Correo electrónico: abat@resportclinic.com
Ubicaciones de estudio
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A Coruña, España, 15009
- Reclutamiento
- Instituto Médico Arriaza
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Contacto:
- Dr Rafael Arriaza, MD
- Número de teléfono: +34 981 113 030
- Correo electrónico: info@arriaza.es
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Barcelona, España, 08023
- Reclutamiento
- Instituto Cugat
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Contacto:
- Dr Ramón Cugat, MD PhD
- Número de teléfono: +34 938 34 64 50
- Correo electrónico: info@institutocugat.com
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Barcelona, España, 08029
- Reclutamiento
- ReSport Clinic
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Contacto:
- Dr Ferran Abat, MD PhD
- Número de teléfono: +34 932 77 87 09
- Correo electrónico: abat@resportclinic.com
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Madrid, España, 28010
- Reclutamiento
- Ripoll y dePrado Medical Group
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Contacto:
- Dra Patricia Núñez, MD
- Número de teléfono: +34 91 457 78 02
- Correo electrónico: madrid@ripollydeprado.com
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Vitoria-Gasteiz, España, 01010
- Reclutamiento
- Hospital MIKS
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Contacto:
- Dr Mikel Sanchez, MD PhD
- Correo electrónico: pacientes@hospitalmiks.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Analog Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Predictive factors of response to PRP treatment
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ferran Abat Gonzalez, MD PhD, ReSport Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RWE-TDP-20251206
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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