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临床试验/NCT07231471
NCT07231471招募中不适用

Platelet Rich Plasma for Musculoskeletal Conditions

University of Utah1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Visual analog score (pain)

研究概览

简要总结

The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction.

This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditions include, but are not limited to, osteoarthritis (OA) of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

详细描述

Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to osteoarthritis (OA) and other musculoskeletal conditions. Research on PRP has expanded dramatically over the last several decades, elevating its status from snake oil to a proven injection option superior to corticosteroids. It has demonstrated superior efficacy to standard-of-care corticosteroids in numerous musculoskeletal conditions. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid for the most commonly-studied condition, knee OA. Most importantly, just as corticosteroids have been used in numerous musculoskeletal conditions (OA, tendinopathy, bursitis, etc.), PRP has the same potential, but with vastly reduced risk; corticosteroids have many known dangers. To summarize, PRP has demonstrated level 1 evidence of superiority to corticosteroids in pain and function in numerous musculoskeletal conditions, with considerably less risk.

This study will evaluate pain, function, and overall patient satisfaction outcomes for the use of PRP for the treatment of a diverse MSK conditions, including, but not limited to, OA of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 18+ years old
  • Musculoskeletal pathology that may benefit from a PRP injection
  • Failed other conservative treatments

排除标准

  • No active malignancy
  • No active infection in the area of injection
  • No platelet disorder
  • No active systemic infections
  • No patients currently undergoing dialysis

研究组 & 干预措施

Platelet Rich Plasma Injection

Experimental

Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their whole blood and the produced PRP will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months..

干预措施: Platelet Rich Plasma Injection (Biological)

Platelet Rich Plasma Injection

Experimental

Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their whole blood and the produced PRP will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months..

干预措施: Platelet Rich Plasma Preparation (Device)

结局指标

主要结局

Visual analog score (pain)

时间窗: 6 months

The VAS is a 0 to 10 scale, with zero being no pain and ten being the worst pain imaginable for their condition

次要结局

  • Foot and Ankle Outcome Score (FAOS)(1, 3, 6, 12 months)
  • Visual Analog Score (pain)(1, 3, and 12 months)
  • Global satisfaction(1, 3, 6, 12 months)
  • Western Ontario and McMaster Universities Arthritis Index (knee)(1, 3, 6, 12 months)
  • International Hip Outcome Tool 12 (IHOT12)(1, 3, 6, 12 months)
  • EQ-5D(1, 3, 6, 12 months)
  • Visual Analog Score (pain)(1, 3, and 12 months)
  • Global satisfaction(1, 3, 6, 12 months)
  • Western Ontario and McMaster Universities Arthritis Index (knee)(1, 3, 6, 12 months)
  • Disorders of the Arm, Shoulder, and Hand (QuickDASH)(1, 3, 6, 12 months)
  • International Hip Outcome Tool 12 (IHOT12)(1, 3, 6, 12 months)
  • Foot and Ankle Outcome Score (FAOS)(1, 3, 6, 12 months)
  • EQ-5D(1, 3, 6, 12 months)

研究者

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

Daniel Cushman

Principal Investigator, Clinical Professor

University of Utah

研究点 (1)

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