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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Resport Clinic, MD PhD
- Telefonnummer: +34 93 2778709
- E-post: abat@resportclinic.com
Studiesteder
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A Coruña, Spania, 15009
- Rekruttering
- Instituto Médico Arriaza
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Ta kontakt med:
- Dr Rafael Arriaza, MD
- Telefonnummer: +34 981 113 030
- E-post: info@arriaza.es
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Barcelona, Spania, 08023
- Rekruttering
- Instituto Cugat
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Ta kontakt med:
- Dr Ramón Cugat, MD PhD
- Telefonnummer: +34 938 34 64 50
- E-post: info@institutocugat.com
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Barcelona, Spania, 08029
- Rekruttering
- ReSport Clinic
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Ta kontakt med:
- Dr Ferran Abat, MD PhD
- Telefonnummer: +34 932 77 87 09
- E-post: abat@resportclinic.com
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Madrid, Spania, 28010
- Rekruttering
- Ripoll y dePrado Medical Group
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Ta kontakt med:
- Dra Patricia Núñez, MD
- Telefonnummer: +34 91 457 78 02
- E-post: madrid@ripollydeprado.com
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Vitoria-Gasteiz, Spania, 01010
- Rekruttering
- Hospital MIKS
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Ta kontakt med:
- Dr Mikel Sanchez, MD PhD
- E-post: pacientes@hospitalmiks.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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 |
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analog Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Predictive factors of response to PRP treatment
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ferran Abat Gonzalez, MD PhD, ReSport Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RWE-TDP-20251206
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