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
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Resport Clinic, MD PhD
- 전화번호: +34 93 2778709
- 이메일: abat@resportclinic.com
연구 장소
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A Coruña, 스페인, 15009
- 모병
- Instituto Médico Arriaza
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연락하다:
- Dr Rafael Arriaza, MD
- 전화번호: +34 981 113 030
- 이메일: info@arriaza.es
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Barcelona, 스페인, 08023
- 모병
- Instituto Cugat
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연락하다:
- Dr Ramón Cugat, MD PhD
- 전화번호: +34 938 34 64 50
- 이메일: info@institutocugat.com
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Barcelona, 스페인, 08029
- 모병
- ReSport Clinic
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연락하다:
- Dr Ferran Abat, MD PhD
- 전화번호: +34 932 77 87 09
- 이메일: abat@resportclinic.com
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Madrid, 스페인, 28010
- 모병
- Ripoll y dePrado Medical Group
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연락하다:
- Dra Patricia Núñez, MD
- 전화번호: +34 91 457 78 02
- 이메일: madrid@ripollydeprado.com
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Vitoria-Gasteiz, 스페인, 01010
- 모병
- Hospital MIKS
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연락하다:
- Dr Mikel Sanchez, MD PhD
- 이메일: pacientes@hospitalmiks.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Predictive factors of response to PRP treatment
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RWE-TDP-20251206
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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