Characterizing Knee Pain and Response to Surgery Using Local Biomarkers
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Lavage of the operative and contralateral knee for comparison are performed under anesthesia prior to arthroscopy by the infusion of 10cc sterile saline into the knee joint followed by the immediate withdrawal into the syringe, and storage at -80°C in a tube containing a protease inhibitor. At 12wk post-operative a 10cc lavage is performed on the knee that underwent surgery. Clinical findings for each sample are quantified using gold-standard symptom severity questionnaires.
The specimens will be analyzed for 31 potential biomarkers using a multiplexed immunoassay panel, the results of which will be compared with pre- and post-operative clinical findings and radiographic imaging. Plans do not currently include microarray analysis, but this may be later included.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University School of Medicine
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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
Our study population includes adult males and females presenting to a single orthopaedic surgeon for arthroscopic management of acute or chronic knee pain due to a mechanical derangement discernable by MRI.
Subjects are selected using a probability sampling scheme, such that every knee arthroscopy patient that presents, without exclusionary criteria described above, is offered enrollment in the study. To date, approximately 85% of patients consent to enrollment, with no apparent sampling bias. Additionally, we are using repeated measures (matched random sampling) to evaluate the role of mediators of knee pain, and to assess the potential of utilizing expression profiles to monitor surgical outcome. For example, clinical indicators and biomarker expression profiles taken peri-operatively are compared to those obtained 12 weeks post-operatively in the same subject.
Descripción
Inclusion Criteria:
•Adult patients with knee pain (acute or chronic) who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both, absence of severe joint space narrowing on plain radiography, and the presence of grade III signal changes on MRI in an anatomic location consistent with the history and physical examination.
Exclusion Criteria:
- Less than 18 years old.
- Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis).
- In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Surgical outcome: pain and functionality
Periodo de tiempo: 12-24wk post-operative.
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12-24wk post-operative.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Expression profiles of inflammatory mediators
Periodo de tiempo: 24wk
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24wk
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason L Dragoo, MD, Stanford University
- Silla de estudio: Eric Leroux, Stanford University
- Silla de estudio: Amy Wasterlain, Stanford University
- Investigador principal: Gaetano Scuderi, MD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SU-07292009-3441
- IRB 16305 (Otro identificador: Stanford IRB)
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