The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Increased age, larger tear size, and more advanced fatty degeneration of the rotator cuff musculature have been correlated with poorer healing rates after rotator cuff repair. Platelets are an endogenous source of growth factors present during rotator cuff healing.
The investigators hypothesis is that augmentation of rotator cuff repairs with platelet-rich fibrin matrix (PRFM) may improve the biology of rotator cuff healing and thus improve functional outcome scores and retear rates after repair.
Rotator cuff tears at risk for retear were prospectively identified using an algorithm; points were assigned for age (50-59 years = 1; 60-69 years = 2; .70 years = 3), anterior-to-posterior tear size (2-2.9 cm = 0; 3-3.9 cm = 1; .4 cm = 2), and fatty atrophy (Goutallier score 0-2 = 0; Goutallier score 3-4 = 1). Three points were required for enrollment. Arthroscopic rotator cuff repair was performed with the addition of PRFM. Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores were obtained. Imaging and functional outcomes were compared with historical controls meeting the same enrollment criteria.
Enrollment for the study began in September 2008 and continued until March 2010.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Utah
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Salt Lake city, Utah, Estados Unidos, 84108
- University Of Utah Orthopedics Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Algorithm score greater and equal to 3
- Both men and women over the age of 50
- Full-thickness rotator cuff tear at least 2 cm in size
- Tear repairable by arthoscopic-only techniques
Exclusion Criteria:
- Inflamation joint disease
- Active use of oral steroids
- Irreparable rotator cuff tear
- Subscapularis tear requiring open repair
- Claustrophobia
- Prior rotator cuff sugery on the affected shoulder
- Failure to return for follow-up magnetic resonance imaging scan
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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PRFM Group
Patients were selected prospectively for the study based on a 3-part algorithm used to identify rotator cuff tears at risk for retear.
A total algorithm score of 3 or greater was required for enrollment in the study.
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Control Group
The control group were recruited retrospectively.
Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRFM augmentation will be encouraged to participate by letter initially, and then by telephone invitation.
The same inclusion and exclusion criteria applied.
MRI, pain, and functional scores will be collected in the same manner as the PRFM group at one time point at least one year post operatively.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
Periodo de tiempo: 1 year
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Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage.
Shoulder pain scores, functional scores, and MRI data will be obtained pre-operatively and compared to the same data collected 1 year post-operatively.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert Burks, MD, University Of Utah Orthopedics Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 29598
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