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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Resport Clinic, MD PhD
- Telefonnummer: +34 93 2778709
- E-post: abat@resportclinic.com
Studieorter
-
-
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A Coruña, Spanien, 15009
- Rekrytering
- Instituto Médico Arriaza
-
Kontakt:
- Dr Rafael Arriaza, MD
- Telefonnummer: +34 981 113 030
- E-post: info@arriaza.es
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Barcelona, Spanien, 08023
- Rekrytering
- Instituto Cugat
-
Kontakt:
- Dr Ramón Cugat, MD PhD
- Telefonnummer: +34 938 34 64 50
- E-post: info@institutocugat.com
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Barcelona, Spanien, 08029
- Rekrytering
- ReSport Clinic
-
Kontakt:
- Dr Ferran Abat, MD PhD
- Telefonnummer: +34 932 77 87 09
- E-post: abat@resportclinic.com
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Madrid, Spanien, 28010
- Rekrytering
- Ripoll y dePrado Medical Group
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Kontakt:
- Dra Patricia Núñez, MD
- Telefonnummer: +34 91 457 78 02
- E-post: madrid@ripollydeprado.com
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Vitoria-Gasteiz, Spanien, 01010
- Rekrytering
- Hospital MIKS
-
Kontakt:
- Dr Mikel Sanchez, MD PhD
- E-post: pacientes@hospitalmiks.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patellar tendinopathy
Patellar 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 |
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analog Scale
Tidsram: From baseline up to 12 months post-treatment
|
From baseline up to 12 months post-treatment
|
|
|
VISA-P
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Predictive factors of response to PRP treatment
Tidsram: baseline
|
Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
|
baseline
|
|
Adverse events
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ferran Abat Gonzalez, MD PhD, ReSport Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RWE-TDP-20251206
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