Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
研究概览
简要总结
The investigators hypothesize that a single injection of platelet-poor plasma (PPP) into an acute muscle injury will significantly improve local muscle regeneration and patient outcomes compared to the standard of care using only ultrasound-guided hematoma aspiration. Muscle regeneration will be assessed through quantitative MRI analysis. The investigators anticipate that PPP injections will lead to a measurable reduction in scar tissue and an increase in regenerated muscle tissue at the injury site over a six-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 45 years
- •Diagnosis of a muscle strain in the lower extremities, including but not limited to hamstring, quadriceps, and gastrocnemius
- •Injury occurred within 10 days of the initial clinical evaluation
- •Injury occurred while engaging in athletic or sporting activities
- •Participants must be willing to undergo prescribed physical therapy
- •Participants have agreed to standard-of-care management for their injury, which may include ultrasound-guided aspiration with or without a platelet-poor plasma injection
排除标准
- •Previous injection at the injury site.
- •Pregnant or breastfeeding women, or women who may become pregnant during the study duration
- •Injuries resulting from puncture or crush trauma
- •Injuries occurring more than 10 days prior to the injection date
- •Injuries not caused by athletic or sporting activity
- •Previous muscle injury in the same muscle group within 6 months
研究组 & 干预措施
No Injection Arm
Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.
PPP Injection Treated Arm
US-guided aspiration of hematoma (if present) and injection of small volume (1-6cc's) of autologous platelet poor plasma (PPP) at the site of injury and post-injection physical therapy.
干预措施: Platelet Poor Plasma (PPP) Injection (Device)
结局指标
主要结局
Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
时间窗: Bseline MRI and 6-month follow-up MRI
Scar tissue volume at the site of acute muscle injury will be measured using quantitative mapping magnetic resonance imaging (MRI). MRI images will be segmented using SyngoVia software to identify abnormal (scar) tissue within the injured muscle. Scar tissue volume will be calculated in cubic centimeters (cm³). This outcome measure represents the change in scar tissue volume, calculated as the difference between baseline MRI and 6-month follow-up MRI measurements. A lower scar tissue volume indicates greater muscle regeneration and reduced fibrosis.
Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
时间窗: Baseline MRI and 6-month follow-up MRI
Scar tissue volume at the site of acute muscle injury will be measured using quantitative mapping magnetic resonance imaging (MRI). MRI images will be segmented using software to identify abnormal (scar) tissue within the injured muscle. Scar tissue volume will be calculated in cubic centimeters (cm³). This outcome measure represents the change in scar tissue volume, calculated as the difference between baseline MRI and 6-month follow-up MRI measurements. A lower scar tissue volume indicates greater muscle regeneration and reduced fibrosis.
次要结局
未报告次要终点