A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)
2 de mayo de 2022 actualizado por: Smith & Nephew, Inc.
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.
Tipo de estudio
De observación
Inscripción (Actual)
128
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
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85016
- Hedley Orthopedics
-
-
California
-
Santa Barbara, California, Estados Unidos, 93105
- Santa Barbara Cottage Hospital
-
-
Michigan
-
Battle Creek, Michigan, Estados Unidos, 49015
- Bronson Orthopedic Specialists
-
-
Ohio
-
New Albany, Ohio, Estados Unidos, 43054
- OrthoNeuro New Albany
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- Rothman Institute
-
-
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
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
Descripción
Inclusion Criteria:
- Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
- Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.
Exclusion Criteria:
- Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
- Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
- Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
- Subject, in the opinion of the Investigator, was morbidly obese.
- Subject, in the opinion of the Investigator, was contraindicated for UKR.
- Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
- Subject (prospective subjects only) is a prisoner.
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Periodo de tiempo: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
|
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
|
Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Periodo de tiempo: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function. Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points. Higher scores indicated a better outcome. |
Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
Periodo de tiempo: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health). Domain Scores: Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25 Sub-domain Scores: Physical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10 Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100 A higher score indicates a better outcome. |
Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: Preoperative (Baseline)
|
Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
Preoperative (Baseline)
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 6 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
6 months postoperatively
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 12 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
12 months postoperatively
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 18 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
18 months postoperatively
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 24 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
24 months postoperatively
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 30 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
30 months postoperatively
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Periodo de tiempo: 36 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
36 months postoperatively
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Beate Hanson, MD, PhD, Smith & Nephew, 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 (Actual)
10 de julio de 2017
Finalización primaria (Actual)
29 de noviembre de 2017
Finalización del estudio (Actual)
29 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
2 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
2 de marzo de 2017
Publicado por primera vez (Actual)
7 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
2 de mayo de 2022
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 16-NPFS-11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .