Cohort Study of PPP Injections for Athletes With Muscle Injury
4 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jason L Dragoo, MD
- Número de teléfono: 303-724-1055
- Correo electrónico: J.DRAGOO@CUANSCHUTZ.EDU
Copia de seguridad de contactos de estudio
- Nombre: Inverness Clinical Trials
- Correo electrónico: Inverness.clinicaltrials@cuanschutz.edu
Ubicaciones de estudio
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Colorado
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Englewood, Colorado, Estados Unidos, 80112
- University of Colorado | Steadman Hawkins Clinic Denver
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Contacto:
- Jason L Dragoo, MD
- Número de teléfono: 720-872-4836
- Correo electrónico: J.DRAGOO@CUANSCHUTZ.EDU
-
Contacto:
- Inverness Clinical Trials
- Número de teléfono: 720-872-4836
- Correo electrónico: Inverness.clinicaltrials@cuanschutz.edu
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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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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Sin intervención: No Injection Arm
Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
1 de junio de 2030
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 22-1841
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .