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Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function

14 de mayo de 2015 actualizado por: University of Colorado, Denver

Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty

Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

44

Fase

  • Fase 2

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

    • Colorado
      • Boulder, Colorado, Estados Unidos, 80304
        • University of Colorado Health Sciences Center
      • Denver, Colorado, Estados Unidos, 80262
        • University of Colorado Health Sciences Center
      • Denver, Colorado, Estados Unidos, 80206
        • National Jewish Medical and Research Center

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

50 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
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:
  • TKA Min
Comparador activo: 2
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:
  • TKA Traditional

¿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
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Range of Motion
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Flexion Active Range of Motion (AROM)
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks

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
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test
Periodo de tiempo: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
This outcome measures the time (seconds) it takes to climb up and back down 12 steps.
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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 junio de 2008

Finalización primaria (Actual)

1 de febrero de 2011

Finalización del estudio (Actual)

1 de enero de 2012

Fechas de registro del estudio

Enviado por primera vez

27 de junio de 2008

Primero enviado que cumplió con los criterios de control de calidad

2 de julio de 2008

Publicado por primera vez (Estimar)

4 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de junio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

14 de mayo de 2015

Última verificación

1 de marzo de 2015

Más información

Términos relacionados con este estudio

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.)

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. .

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