- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01811563
Total Knee Arthroplasty: Functional and Clinical Outcomes
28 de abril de 2017 actualizado por: Duke University
Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants.
In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery.
All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA.
Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest.
The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes.
This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making.
Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
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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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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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 a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients requiring primary total knee replacement
- Patients willing and able to comply with the follow-up visits and evaluations
- Patients willing to sign informed consent approved by the Institutional Review Board
Exclusion Criteria:
- Patients with inflammatory arthritis
- Patients with diabetic neuropathy
- Patients unable to ambulate without the use of an assistive device prior to surgery
- Patients unable to stand in single limb stance on each foot prior to surgery.
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
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Comparador activo: Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
Periodo de tiempo: Baseline (Pre-Operative) to 6 weeks following total knee replacement
|
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
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Baseline (Pre-Operative) to 6 weeks following total knee replacement
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Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
Periodo de tiempo: Baseline (Pre-Operative) to 52 weeks following total knee replacement
|
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
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Baseline (Pre-Operative) to 52 weeks following total knee replacement
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Periodo de tiempo: Baseline and 52 weeks following total knee replacement
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Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
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Baseline and 52 weeks following total knee replacement
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Walking Speed at 6 Weeks Following Total Knee Replacement.
Periodo de tiempo: 6 weeks following total knee replacement
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Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
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6 weeks following total knee replacement
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
Periodo de tiempo: Baseline and 52 weeks following total knee replacement
|
The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
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Baseline and 52 weeks following total knee replacement
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University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
Periodo de tiempo: 6 weeks following total knee replacement
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The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
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6 weeks following total knee replacement
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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
Periodo de tiempo: Baseline (Pre-Operative) and 52 weeks following total knee replacement
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The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
The previous week is the time period considered when answering the questions.
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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Baseline (Pre-Operative) and 52 weeks following total knee replacement
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Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
Periodo de tiempo: 6 weeks and 52 weeks following total knee replacement
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The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant.
The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport.
Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction.
Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100.
The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
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6 weeks and 52 weeks following total knee replacement
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Knee Society Score (KSS)
Periodo de tiempo: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement.
This outcome measures both patient reported pain and function changes from prior to surgery through recovery.
The score range is from 0 to 100.
The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Sit to Stand Time
Periodo de tiempo: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Timed Get up and go
Periodo de tiempo: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Samuel S Wellman, MD, Duke University
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 2013
Finalización primaria (Actual)
26 de febrero de 2016
Finalización del estudio (Actual)
26 de febrero de 2016
Fechas de registro del estudio
Enviado por primera vez
12 de marzo de 2013
Primero enviado que cumplió con los criterios de control de calidad
12 de marzo de 2013
Publicado por primera vez (Estimar)
14 de marzo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00043737
- 193447 (Otro número de subvención/financiamiento: Stryker)
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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