Patellar TendinopathyRWE-TDP-PRPNCT07558564
Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies
An observational study of Patellar Tendinopathy and Achilles Tendinopathy (AT), run by ReSport Clinic at 5 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Tendinopathy, Achilles Tendinopathy (AT), Epicondylitis, Lateral
- What is being tested?
- Platelet rich plasma (PRP)
- How many people
- 2,000 participants
- Where
- 5 sitesSpain
- Study dates
- Apr 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Instituto Médico Arriaza
A Coruña, 15009
Dr Rafael Arriaza, MD, +34 981 113 030, info@arriaza.es
- Recruiting
Instituto Cugat
Barcelona, 08023
Dr Ramón Cugat, MD PhD, +34 938 34 64 50, info@institutocugat.com
- Recruiting
ReSport Clinic
Barcelona, 08029
Dr Ferran Abat, MD PhD, +34 932 77 87 09, abat@resportclinic.com
- Recruiting
Ripoll y dePrado Medical Group
Madrid, 28010
Dra Patricia Núñez, MD, +34 91 457 78 02, madrid@ripollydeprado.com
- Recruiting
Hospital MIKS
Vitoria-Gasteiz, 01010
Dr Mikel Sanchez, MD PhD, pacientes@hospitalmiks.com
About this study
Official title: Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies
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.
- Conditions
- Patellar Tendinopathy, Achilles Tendinopathy (AT), Epicondylitis, Lateral, Plantar Fasciitis, Chronic
- Being tested
- Platelet rich plasma (PRP)
- Keywords
- tendinopathy, Real World Evidence (RWE), platelet-rich plasma, plantar fasciosis, epicondylitis, patellar tendon, Achilles tendon
- Medical subject headings
- Tennis Elbow, Fasciitis, Plantar, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patellar tendinopathy | Patellar tendinopathy treated with PRP Receives: Biological: Platelet rich plasma (PRP) | |
| Achilles tendinopathy | Achilles tendinopathy treated with PRP Receives: Biological: Platelet rich plasma (PRP) | |
| Plantar fasciosis | Plantar fasciosis treated with PRP Receives: Biological: Platelet rich plasma (PRP) | |
| Chronic epycondylitis | Chronic epycondylitis treated with PRP Receives: Biological: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline, 1 month, 3 months, 6 months and 12 months
Secondary outcomes (2)
Predictive factors of response to PRP treatment
Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence
Measured: baseline
Adverse events
Assess the incidence of local or systemic adverse events following PRP administration
Measured: 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReSport Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- BioSmartData
- Responsible party
- Sponsor
- Investigators
- Ferran Abat Gonzalez, MD PhD, Principal investigator, ReSport Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558564
- Sponsor's protocol ID
- RWE-TDP-20251206
- Acronym
- RWE-TDP-PRP
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies
- ClinicalTrials.gov ID
- NCT07558564
- Acronym / sponsor ID
- RWE-TDP-PRP / RWE-TDP-20251206
- Conditions
- Patellar Tendinopathy, Achilles Tendinopathy (AT), Epicondylitis, Lateral, Plantar Fasciitis, Chronic
- Keywords
- tendinopathy, Real World Evidence (RWE), platelet-rich plasma, plantar fasciosis, epicondylitis, patellar tendon, Achilles tendon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ReSport ClinicUniversity, hospital or other
- Collaborators
- BioSmartData
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patellar tendinopathy | – | Biological: Platelet rich plasma (PRP)Patellar tendinopathy treated with PRP |
| Achilles tendinopathy | – | Biological: Platelet rich plasma (PRP)Achilles tendinopathy treated with PRP |
| Plantar fasciosis | – | Biological: Platelet rich plasma (PRP)Plantar fasciosis treated with PRP |
| Chronic epycondylitis | – | Biological: Platelet rich plasma (PRP)Chronic epycondylitis treated with PRP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma (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 | Biological | Achilles tendinopathy, Chronic epycondylitis, Patellar tendinopathy, Plantar fasciosis |
Primary outcome
Visual Analog Scale
Time frame: From baseline up to 12 months post-treatment
VISA-P
Time frame: 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.
VISA-A
Time frame: 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).
Patient Rated Tennis Elbow Evaluation Scale
Time frame: 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.
Foot Function Index
Time frame: 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.
2 secondary outcomes
Predictive factors of response to PRP treatment
Time frame: baseline
Adverse events
Time frame: 1 month, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Patellar Tendinopathy
Enrolling by invitation
Photobiomodultion in Anterior Knee Pain
Anterior Knee Pain, Photobiomodulation (PBM)
Recruiting
Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk
Patellar Tendinitis, Jumper's Knee
Active, not recruiting
Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT
Chronic Patellar Tendinopathy
Enrolling by invitation
Effects of Resistance Training on Patellar Tendon Properties in People With Patellar Tendinoapthy
Patellar Tendinopathy
Active, not recruiting
Unlocking the Hidden Effects of Shockwave: Longitudinal Changes in Sensorimotor Function and Kinesiophobia in Adolescents With Patellar Tendinopathy
Patellar Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferran Abat Gonzalez, MD PhD principal investigator
ReSport Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Tendinopathy and Achilles Tendinopathy (AT), run by ReSport Clinic at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Resport Clinic, MD PhD (+34 93 2778709, abat@resportclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: From baseline up to 12 months post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.