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临床试验/NCT06422390
NCT06422390撤回不适用

Platelet - Rich Plasma Injections for Rotator Cuff Tears

Scripps Clinic1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
入组人数
76
试验地点
1
主要终点
Improvement of pain and function

研究概览

简要总结

Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options.

Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling.

Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI
  • Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with ultrasound.

排除标准

  • Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy)
  • Patient with previous surgical interventions on the same rotator cuff.
  • Patients on aspirin who cannot discontinue medication 1 week prior and 6 weeks after the procedure.
  • Patients who decline to discontinue anti-inflammatory medications or supplements for 1 week prior and 6 weeks after the procedure.
  • Any procedure that utilized less than 2-3 cc of PRP
  • Patients that require blood to be drawn twice on the same day.

研究组 & 干预措施

PRP Injection

Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.

干预措施: Platelet - Rich Plasma (Biological)

结局指标

主要结局

Improvement of pain and function

时间窗: June 2024 to June 2025

Primary outcome: Improvement in patients' subjective pain and function as measured by the American Shoulder and Elbow Surgeons (ASES) score at 6 weeks, 12 weeks, 6 months, and 1 year. Minimum value: No difficulty with normal function of the shoulder and there is no pain. Maximum value: Extreme difficulty with normal function and the pain is as bad as it can be. Pain scale is 0 to 10 with the meaning that scale starts from 0 (no pain) to 10 (pain as bad as it can be).

次要结局

  • Improvement in VAS scores and patient satisfaction(June 2024 to June 2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laika Nur

Clinical Assistant Professor of Orthopedic Surgery - Division of Sports Medicine

Scripps Clinic

研究点 (1)

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