Lower Extremity Injury
Conditions
Keywords
Lower extremity injury, PPP injection, Platelet Poor Plasma injection, Athlete, muscle injury
Brief summary
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.
Interventions
DEVICEPlatelet Poor Plasma (PPP) Injection
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.
Sponsors
University of Colorado, Denver
Emory University
University of Iowa
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping | 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. |
Countries
United States
Contacts
CONTACTJason L Dragoo, MD
CONTACTInverness Clinical Trials
Outcome results
None listed