- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01204736
Comparing Outcomes of Elbow Extension Tendon Transfers
A Comparison of Two Surgical Procedures That Restore Elbow Extension
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.
The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Hines, Illinois, Estados Unidos, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
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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:
- Cervical Spinal Cord Injury (C5-C7)
- Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
- Biceps to Triceps Tendon Transfer at least one year post-surgery
Exclusion Criteria:
Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:
- unhealed decubiti
- use of baclofen pumps
- existing infection
- cardiovascular disease
- significant osteoporosis (as indicated by a history of fractures following injury)
- or a history of pulmonary complications or autonomic dysreflexia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1
Subjects with posterior deltoid-to-triceps tendon transfers
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Group 2
Subjects with biceps-to-triceps tendon transfers
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Group 3
Subjects with cervical SCI who have not had tendon transfers
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Group 4
Unimpaired control subjects
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Elbow Extension Strength
Periodo de tiempo: At least one year post surgery
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Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate.
We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions.
Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds.
The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.
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At least one year post surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wendy M Murray, PhD, Edward Hines Jr. VA Hospital, Hines, IL
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
- B7515-R
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