Vertos Mild - Post Market Patient Outcomes
22 de febrero de 2013 actualizado por: The Center for Pain Relief, Inc.
Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.
The patients will be followed for 6 months after the procedure.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks.
Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
Tipo de estudio
Intervencionista
Inscripción (Actual)
46
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.
Ubicaciones de estudio
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25301
- The Center for Pain Relief, Inc
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Charleston, West Virginia, Estados Unidos, 25301
- The Center for Pain Relief, Inc.
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- Able to walk at least 10 feet unaided before being limited by pain
- Available to complete 26 weeks of follow up
- A signed Consent Form is obtained from the patient
- Adults 18 years of age or older
Exclusion Criteria:
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- Disc protrusion or osteophyte formation severe enough to confound study outcome
- Facet hypertrophy severe enough to confound study outcome
- Bleeding disorders and/or current use of anti-coagulants
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
- Epidural steroids with 3 weeks prior to procedure
- Inability of patient to lie prone for any reason with anesthesia support
- Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
- Dementia and/or inability to give informed consent
- Pregnant and/or breastfeeding
- On workman's Compensation or considering litigation associated with back pain
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Minimally invasive lumbar decompression
|
This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine.
The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring.
Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process.
The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain as Measured by Visual Analog Scale (VAS).
Periodo de tiempo: Baseline and six months
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A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain.
The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
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Baseline and six months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement in Functional Mobility
Periodo de tiempo: baseline and month 6
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Measured subjectively by the Oswestry Disability Index.
Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity.
The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking.
Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations.
The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
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baseline and month 6
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Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
Periodo de tiempo: Baseline and month 6
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As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator.
A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms.
The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value.
Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
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Baseline and month 6
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Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
Periodo de tiempo: Baseline and month 6
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For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function.
Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6.
A positive value represents the baseline value minus the 6 month value.
Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.
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Baseline and month 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Timothy R Deer, MD, Center for Pain Relief, Inc
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
1 de febrero de 2010
Finalización primaria (Actual)
1 de enero de 2012
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
24 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
25 de febrero de 2010
Publicado por primera vez (Estimar)
26 de febrero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de abril de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
22 de febrero de 2013
Última verificación
1 de febrero de 2013
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- #D1
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. .