Cohort Study of PPP Injections for Athletes With Muscle Injury
4 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
90
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jason L Dragoo, MD
- Numero di telefono: 303-724-1055
- Email: J.DRAGOO@CUANSCHUTZ.EDU
Backup dei contatti dello studio
- Nome: Inverness Clinical Trials
- Email: Inverness.clinicaltrials@cuanschutz.edu
Luoghi di studio
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Colorado
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Englewood, Colorado, Stati Uniti, 80112
- University of Colorado | Steadman Hawkins Clinic Denver
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Contatto:
- Jason L Dragoo, MD
- Numero di telefono: 720-872-4836
- Email: J.DRAGOO@CUANSCHUTZ.EDU
-
Contatto:
- Inverness Clinical Trials
- Numero di telefono: 720-872-4836
- Email: Inverness.clinicaltrials@cuanschutz.edu
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
-
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- University of Iowa
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Nessun intervento: No Injection Arm
Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
Lasso di tempo: 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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
1 giugno 2030
Completamento dello studio (Stimato)
31 dicembre 2030
Date di iscrizione allo studio
Primo inviato
28 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2026
Primo Inserito (Effettivo)
4 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 22-1841
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No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .