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| Name | Class |
|---|---|
| BioSmartData | OTHER |
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This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterization, clinical variables, treatment protocols, and longitudinal assessment of therapeutic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patellar tendinopathy | Patellar tendinopathy treated with PRP |
| |
| Achilles tendinopathy | Achilles tendinopathy treated with PRP |
| |
| Plantar fasciosis | Plantar fasciosis treated with PRP |
| |
| Chronic epycondylitis | Chronic epycondylitis treated with PRP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma (PRP) | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | From baseline up to 12 months post-treatment | |
| VISA-P | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive factors of response to PRP treatment | Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence | baseline |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (>18 years), of both sexes, diagnosed with patellar, Achilles, epicondylar tendinopathy or plantar fasciosis, who have received PRP treatment according to physician discretion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Resport Clinic, MD PhD | Contact | +34 93 2778709 | abat@resportclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Ferran Abat Gonzalez, MD PhD | ReSport Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Médico Arriaza | Recruiting | A Coruña | 15009 | Spain |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| D036981 | Fasciitis, Plantar |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
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Assess the incidence of local or systemic adverse events following PRP administration
| 1 month, 3 months, 6 months, 12 months |
| Instituto Cugat | Recruiting | Barcelona | 08023 | Spain |
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| ReSport Clinic | Recruiting | Barcelona | 08029 | Spain |
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| Ripoll y dePrado Medical Group | Recruiting | Madrid | 28010 | Spain |
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| Hospital MIKS | Recruiting | Vitoria-Gasteiz | 01010 | Spain |
|
| D001134 |
| Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D005208 | Fasciitis |
| D005534 | Foot Diseases |