Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)
Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Redwood City, California, Estados Unidos, 94063
- Stanford University Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Exclusion Criteria:
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
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The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Otros nombres:
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Comparador activo: Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
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Microfracture performed with no post-operative unloader bracing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Periodo de tiempo: 2 years
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KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Tegner Score (Clinical Outcome)
Periodo de tiempo: 2 years
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The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports.
The patient is asked to select the level of participation that best describes their current level of activity and that before injury.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
A score >6 can only be achieved if the person participates in recreational or competitive sport.
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2 years
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Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Periodo de tiempo: 2 years
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SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
A higher value indicates a better quality of life of the patient.
The scores range from 0 to 100.
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2 years
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Change From Baseline in Lysholm Score (Clinical Outcome)
Periodo de tiempo: 2 years
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The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
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2 years
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Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Periodo de tiempo: 2 years
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T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
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2 years
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Change From Baseline in Cartilage Volume (Radiographic Outcome)
Periodo de tiempo: 2 years
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2 years
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Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Periodo de tiempo: 2 years
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2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason Dragoo, MD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- oss-mfx-2013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Unloader Bracing
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