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Not yet recruiting NCT07566039

Cohort Study of PPP Injections for Athletes With Muscle Injury

No phase Interventional Lower Extremity Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet Poor Plasma (PPP) Injection.
Who it may be relevant to
Registry conditions: Lower Extremity Injury. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury

Overview

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

  • Device Platelet 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.

Primary outcome measures

  • Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping [Time frame: Baseline MRI and 6-month follow-up MRI]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Colorado | Steadman Hawkins Clinic Denver — Englewood
  • Emory University — Atlanta
  • University of Iowa — Iowa City

Publications

  • Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK. Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. J Extra Corpor Technol. 2007 Sep;39(3):177-82. PMID 17972452
  • Yilmaz S, Kabadayi C, Ipci SD, Cakar G, Kuru B. Treatment of intrabony periodontal defects with platelet-rich plasma versus platelet-poor plasma combined with a bovine-derived xenograft: a controlled clinical trial. J Periodontol. 2011 Jun;82(6):837-44. doi: 10.1902/jop.2010.100503. Epub 2010 Dec 7. PMID 21138357
  • Thierfelder KM, Gerhardt JS, Gemescu IN, Notohamiprodjo S, Rehnitz C, Weber MA. Imaging of hip and thigh muscle injury: a pictorial review. Insights Imaging. 2019 Feb 15;10(1):20. doi: 10.1186/s13244-019-0702-1. PMID 30771029
  • Tchkonia T, Zhu Y, van Deursen J, Campisi J, Kirkland JL. Cellular senescence and the senescent secretory phenotype: therapeutic opportunities. J Clin Invest. 2013 Mar;123(3):966-72. doi: 10.1172/JCI64098. Epub 2013 Mar 1. PMID 23454759
  • Stevens KJ, Crain JM, Akizuki KH, Beaulieu CF. Imaging and ultrasound-guided steroid injection of internal oblique muscle strains in baseball pitchers. Am J Sports Med. 2010 Mar;38(3):581-5. doi: 10.1177/0363546509350105. Epub 2010 Jan 5. PMID 20051499
  • Shahidi M, Vatanmakanian M, Arami MK, Sadeghi Shirazi F, Esmaeili N, Hydarporian S, Jafari S. A comparative study between platelet-rich plasma and platelet-poor plasma effects on angiogenesis. Med Mol Morphol. 2018 Mar;51(1):21-31. doi: 10.1007/s00795-017-0168-5. Epub 2017 Sep 25. PMID 28948378
  • Setayesh K, Villarreal A, Gottschalk A, Tokish JM, Choate WS. Treatment of Muscle Injuries with Platelet-Rich Plasma: a Review of the Literature. Curr Rev Musculoskelet Med. 2018 Dec;11(4):635-642. doi: 10.1007/s12178-018-9526-8. PMID 30343400
  • Otrocka-Domagala I, Pazdzior-Czapula K, Gesek M. Dexamethasone-induced impairment of post-injury skeletal muscle regeneration. BMC Vet Res. 2019 Feb 11;15(1):56. doi: 10.1186/s12917-019-1804-1. PMID 30744624

Identifiers

NCT: NCT07566039 · 22-1841

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗