Cohort Study of PPP Injections for Athletes With Muscle Injury
4. mai 2026 oppdatert av: University of Colorado, Denver
Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jason L Dragoo, MD
- Telefonnummer: 303-724-1055
- E-post: J.DRAGOO@CUANSCHUTZ.EDU
Studer Kontakt Backup
- Navn: Inverness Clinical Trials
- E-post: Inverness.clinicaltrials@cuanschutz.edu
Studiesteder
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Colorado
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Englewood, Colorado, Forente stater, 80112
- University of Colorado | Steadman Hawkins Clinic Denver
-
Ta kontakt med:
- Jason L Dragoo, MD
- Telefonnummer: 720-872-4836
- E-post: J.DRAGOO@CUANSCHUTZ.EDU
-
Ta kontakt med:
- Inverness Clinical Trials
- Telefonnummer: 720-872-4836
- E-post: Inverness.clinicaltrials@cuanschutz.edu
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-
Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
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Ingen inngripen: No Injection Arm
Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
Tidsramme: 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. |
Baseline MRI and 6-month follow-up MRI
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Miroshnychenko O, Chang WT, Dragoo JL. The Use of Platelet-Rich and Platelet-Poor Plasma to Enhance Differentiation of Skeletal Myoblasts: Implications for the Use of Autologous Blood Products for Muscle Regeneration. Am J Sports Med. 2017 Mar;45(4):945-953. doi: 10.1177/0363546516677547. Epub 2016 Dec 27.
- Mueller-Wohlfahrt HW, Haensel L, Mithoefer K, Ekstrand J, English B, McNally S, Orchard J, van Dijk CN, Kerkhoffs GM, Schamasch P, Blottner D, Swaerd L, Goedhart E, Ueblacker P. Terminology and classification of muscle injuries in sport: the Munich consensus statement. Br J Sports Med. 2013 Apr;47(6):342-50. doi: 10.1136/bjsports-2012-091448. Epub 2012 Oct 18.
- Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.
- 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.
- Garg K, Corona BT, Walters TJ. Therapeutic strategies for preventing skeletal muscle fibrosis after injury. Front Pharmacol. 2015 Apr 21;6:87. doi: 10.3389/fphar.2015.00087. eCollection 2015.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Malahias MA, Mavrogenis AF, Nikolaou VS, Megaloikonomos PD, Kazas ST, Chronopoulos E, Babis GC. Similar effect of ultrasound-guided platelet-rich plasma versus platelet-poor plasma injections for chronic plantar fasciitis. Foot (Edinb). 2019 Mar;38:30-33. doi: 10.1016/j.foot.2018.11.003. Epub 2018 Nov 28.
- Liu W, Wang D, Ouyang H, Chen N, Chang B, Zhu Q, Li J. Ultrasound Assessment of Muscle Injury Associated with Closed Limb Fracture. Biomed Res Int. 2019 Jun 11;2019:9365291. doi: 10.1155/2019/9365291. eCollection 2019.
- Levine WN, Bergfeld JA, Tessendorf W, Moorman CT 3rd. Intramuscular corticosteroid injection for hamstring injuries. A 13-year experience in the National Football League. Am J Sports Med. 2000 May-Jun;28(3):297-300. doi: 10.1177/03635465000280030301.
- Laberge RM, Zhou L, Sarantos MR, Rodier F, Freund A, de Keizer PL, Liu S, Demaria M, Cong YS, Kapahi P, Desprez PY, Hughes RE, Campisi J. Glucocorticoids suppress selected components of the senescence-associated secretory phenotype. Aging Cell. 2012 Aug;11(4):569-78. doi: 10.1111/j.1474-9726.2012.00818.x. Epub 2012 Apr 17.
- Kirkland JL, Tchkonia T. Senolytic drugs: from discovery to translation. J Intern Med. 2020 Nov;288(5):518-536. doi: 10.1111/joim.13141. Epub 2020 Aug 4.
- Kearney RS, Ji C, Warwick J, Parsons N, Brown J, Harrison P, Young J, Costa ML; ATM Trial Collaborators. Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial. JAMA. 2021 Jul 13;326(2):137-144. doi: 10.1001/jama.2021.6986.
- Kasitinon D, Dragoo JL, Hwang CE. Use of Platelet-Poor Plasma in Acute Quadriceps Muscle Strain in a Division I Football Placekicker: A Case Report. Curr Sports Med Rep. 2021 Nov 1;20(11):572-574. doi: 10.1249/JSR.0000000000000901. No abstract available.
- Huard J, Li Y, Fu FH. Muscle injuries and repair: current trends in research. J Bone Joint Surg Am. 2002 May;84(5):822-32. No abstract available.
- Hotfiel T, Seil R, Bily W, Bloch W, Gokeler A, Krifter RM, Mayer F, Ueblacker P, Weisskopf L, Engelhardt M. Nonoperative treatment of muscle injuries - recommendations from the GOTS expert meeting. J Exp Orthop. 2018 Jun 22;5(1):24. doi: 10.1186/s40634-018-0139-3.
- Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, Giorgadze N, Hashmi SK, Herrmann SM, Jensen MD, Jia Q, Jordan KL, Kellogg TA, Khosla S, Koerber DM, Lagnado AB, Lawson DK, LeBrasseur NK, Lerman LO, McDonald KM, McKenzie TJ, Passos JF, Pignolo RJ, Pirtskhalava T, Saadiq IM, Schaefer KK, Textor SC, Victorelli SG, Volkman TL, Xue A, Wentworth MA, Wissler Gerdes EO, Zhu Y, Tchkonia T, Kirkland JL. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease. EBioMedicine. 2019 Sep;47:446-456. doi: 10.1016/j.ebiom.2019.08.069. Epub 2019 Sep 18.
- Hamilton B, Valle X, Rodas G, Til L, Grive RP, Rincon JA, Tol JL. Classification and grading of muscle injuries: a narrative review. Br J Sports Med. 2015 Mar;49(5):306. doi: 10.1136/bjsports-2014-093551. Epub 2014 Nov 13.
- Hamilton B, Alonso JM, Best TM. Time for a paradigm shift in the classification of muscle injuries. J Sport Health Sci. 2017 Sep;6(3):255-261. doi: 10.1016/j.jshs.2017.04.011. Epub 2017 Apr 27.
- Hakim M, Hage W, Lovering RM, Moorman CT 3rd, Curl LA, De Deyne PG. Dexamethasone and recovery of contractile tension after a muscle injury. Clin Orthop Relat Res. 2005 Oct;439:235-42. doi: 10.1097/01.blo.0000177716.70404.f9.
- Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Mar;282(3):646-663. doi: 10.1148/radiol.2017160267.
- Grassi A, Quaglia A, Canata GL, Zaffagnini S. An update on the grading of muscle injuries: a narrative review from clinical to comprehensive systems. Joints. 2016 Jun 13;4(1):39-46. doi: 10.11138/jts/2016.4.1.039. eCollection 2016 Jan-Mar.
- Floryan KM, Berghoff WJ. Intraoperative use of autologous platelet-rich and platelet-poor plasma for orthopedic surgery patients. AORN J. 2004 Oct;80(4):668-74, quiz 675-8. doi: 10.1016/s0001-2092(06)61320-3.
- Erfanian Y, Grueneisen J, Kirchner J, Wetter A, Podleska LE, Bauer S, Poeppel T, Forsting M, Herrmann K, Umutlu L. Integrated 18F-FDG PET/MRI compared to MRI alone for identification of local recurrences of soft tissue sarcomas: a comparison trial. Eur J Nucl Med Mol Imaging. 2017 Oct;44(11):1823-1831. doi: 10.1007/s00259-017-3736-y. Epub 2017 May 31.
- Drakos M, Birmingham P, Delos D, Barnes R, Murphy C, Weiss L, Warren R. Corticosteroid and Anesthetic Injections for Muscle Strains and Ligament Sprains in the NFL. HSS J. 2014 Jul;10(2):136-42. doi: 10.1007/s11420-014-9395-7. Epub 2014 May 21.
- Dorio M, Pereira RMR, Luz AGB, Deveza LA, de Oliveira RM, Fuller R. Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. BMC Musculoskelet Disord. 2021 Sep 24;22(1):822. doi: 10.1186/s12891-021-04706-7.
- Delos D, Maak TG, Rodeo SA. Muscle injuries in athletes: enhancing recovery through scientific understanding and novel therapies. Sports Health. 2013 Jul;5(4):346-52. doi: 10.1177/1941738113480934.
- Bentzinger CF, Wang YX, Dumont NA, Rudnicki MA. Cellular dynamics in the muscle satellite cell niche. EMBO Rep. 2013 Dec;14(12):1062-72. doi: 10.1038/embor.2013.182. Epub 2013 Nov 15.
- Batista JD, Justino Oliveira Limirio PH, Rocha FS, Gomes Moura CC, Zanetta-Barbosa D, Dechichi P. Influence of Platelet-Poor Plasma on Angiogenesis and Maintenance of Volume in Autogenous Bone Grafts. J Oral Maxillofac Surg. 2018 Oct;76(10):2097-2102. doi: 10.1016/j.joms.2018.06.024. Epub 2018 Jun 27.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. juni 2030
Studiet fullført (Antatt)
31. desember 2030
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
28. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22-1841
Plan for individuelle deltakerdata (IPD)
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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