- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00710840
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
Descripción general del estudio
Estado
Condiciones
Descripción detallada
More than 400,000 TKAs are performed each year in the United States to alleviate pain and disability associated with knee OA. Although this procedure reliably reduces pain and improves function in people with knee OA, recovery of the strength of the quadriceps muscle to normal levels is rare. For years after a TKA, performance while walking or while doing a more physically demanding activity, such as stair climbing, is also significantly lower in people who have had a TKA than in healthy adults of the same age. Within the past few years, less invasive TKA surgical techniques have been developed as promising alternatives to traditional TKA. Minimally invasive TKA, or TKA(min), achieves the same surgical objectives, but possibly without doing as much damage to the quadriceps muscle as is seen with traditional TKA. No studies, however, have specifically investigated how TKA(min) might preserve quadriceps muscle function. This study will determine whether TKA(min) is better than TKA at improving quadriceps muscle force production and activation, increasing knee range of motion, and reducing post-operative pain to improve overall functional outcomes.
Participants who are scheduled to undergo knee replacement surgery will be randomly assigned to receive either traditional TKA or TKA(min). Prior to surgery, participants will attend a 30-minute orientation session and undergo certain tests to evaluate knee function. Functional testing will include timed walking, stair climbing, balance testing, and knee flexibility measurements. Other evaluations will include thigh muscle strength and activation testing, which uses brief electrical pulses to determine if the muscles are contracted as much as possible, and health status questionnaires. After the operation, participants will be instructed to use walking aids, such as a walker, crutches, or a cane, for a period of time. Participants will attend study visits for repeat testing 48 hours following surgery; at Months 1, 3, and 6; and at Years 1 and 2.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Boulder, Colorado, Estados Unidos, 80304
- University of Colorado Health Sciences Center
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado Health Sciences Center
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Medical and Research 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:
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Exclusion Criteria:
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
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TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee.
This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
Otros nombres:
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Comparador activo: 2
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TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quadriceps Muscle Force
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Knee Range of Motion
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Knee Flexion Active Range of Motion (AROM)
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional Performance: 6 Minute Walk (6MW) Distance
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Functional Performance: Stair Climb Test
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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This outcome measures the time (seconds) it takes to climb up and back down 12 steps.
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jennifer E. Stevens, MPT, PhD, University of Colorado, Denver
- Investigador principal: Michael Dayton, MD, University of Colorado, Denver
- Investigador principal: Wendy Kohrt, PhD, University of Colorado School of Medicine
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
- 06-0183
- R03AR054538 (Subvención/contrato del NIH de EE. UU.)
- 1R03AR054538-01A2 (Subvención/contrato del NIH de EE. UU.)
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