Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
23 de mayo de 2022 actualizado por: Wei Tian, Beijing Jishuitan Hospital
With the change of lifestyle and the aging of the population, the prevalence of Lumbar disc herniation (LDH) in my country is increasing year by year, and surgery is one of the main ways to treat LDH. Surgical robots have good application prospects in the surgical treatment of patients with lumbar degenerative diseases. Studies have shown that orthopedic robot-assisted surgery has less soft tissue damage, small surgical incisions, less bleeding, high safety, and quick postoperative recovery; it reduces the risk of spinal cord and blood vessel damage that may be caused during manual operations; does not require repeated fluoroscopy To determine the position of the nail, reduce the intraoperative radiation by more than 70%, and reduce the risk of patient infection.
The current clinical research on robotics technology mainly stays in the aspects of accuracy, effectiveness, and safety. If the technology is promoted in clinical applications, the support of health economics evaluation data is urgently needed. This study hopes to apply robot-assisted technology in LDH surgical treatment through observational research design, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, focus on health economics evaluation, and provide treatment options for patients and medical care in the health sector. The reasonable allocation of resources and the promotion and application of this technology provide data support.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
Beijing Jishuitan Hospital is a pioneer in the research and application of orthopedic robotics in my country.
At present, it has completed hundreds of orthopedic surgeries using the "Tianji" robotic system, and has completed a number of randomized controlled clinical trials, proving that robot-assisted surgery is effective in bone degenerative diseases Safety and accuracy in surgical treatment.
Based on this platform, this research hopes to apply robot-assisted technology in the treatment of patients with lumbar intervertebral disc herniation, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, and focus on health economics evaluation, and provide treatment options for patients and health departments The reasonable allocation of medical resources and the promotion and application of this technology provide data support.
Tipo de estudio
De observación
Inscripción (Anticipado)
600
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.
Estudio Contacto
- Nombre: mingxing fan, MD,PHD
- Número de teléfono: +86-13683360600
- Correo electrónico: van0208@163.com
Ubicaciones de estudio
-
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Beijing
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Beijing, Beijing, Porcelana, 100000
- Beijing Jishuitan Hospital
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Contacto:
- Mingxing Fan, MD
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients who come to our hospital and meet the inclusion and exclusion criteria
Descripción
Inclusion Criteria:
- Diagnose lumbar degenerative diseases and lumbar fractures
- single-level lumbar pedicle screw internal fixation
- Sign informed consent
Exclusion Criteria:
- Multi-level lumbar pedicle screw internal fixation
- QCT diagnoses severe osteoporosis (BMD <60mg/cm3).
- Combined with abnormal coagulation function
- Combined with serious medical diseases
- Spinal cord injury, paraplegia
- The doctor or nurse believes that it is not appropriate to enroll patients (such as unable to cooperate in completing the study, unable to communicate effectively, severe mental anxiety, lower limb movement disorders, etc.)
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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free-hand
spine surgery without robot
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robot-assisted
Robot-assisted open surgery
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Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
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mi
Robot-assisted minimally invasive surgery
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Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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COST
Periodo de tiempo: Up to 12 months
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Perioperative cost
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Up to 12 months
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Visual Analogue Scale
Periodo de tiempo: Up to 12 months
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The basic method is to use a moving ruler with a length of about 10cm.
One side is marked with 10 scales.
The two ends are respectively "0" and "10" points.
A point of 0 means no pain, and a point of 10 means the most intolerable Severe pain.
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Up to 12 months
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Oswestry Disability Index
Periodo de tiempo: Up to 12 months
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The minimum score for each item is 0 points, and the highest score is 5 points.
The higher the score, the more severe the degree of dysfunction; the corresponding scores of the 10 items are accumulated.
Calculate the percentage of the highest score (50 points) of the 10 items, which is the Oswestry dysfunction index.
The higher the score, the more severe the patient's dysfunction.
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Up to 12 months
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modified Japanese orthopaedic association score
Periodo de tiempo: Up to 12 months
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Spinal function scoring method, including limb movement, sensory and bladder function evaluation, a total of 17 points.
The higher the score, the better the recovery of spinal cord function.
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Up to 12 months
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SF-36(Medical Outcomes Study Short-Form 36)
Periodo de tiempo: Up to 12 months
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Medical Outcomes Study S hort-Form 36.
There are 8 dimensions to evaluate health-related life quality (HRQOL), which are divided into two categories: physical health and physical health, namely physical function (PF), physical function (RP), physical pain (BP), General health (CH), vitality (VT), social function (SF), emotional function (RE), mental health (MH).
The score is between 0-100, a high score indicates a good health.
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Up to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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operation time
Periodo de tiempo: During surgery
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operation time
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During surgery
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blood lose
Periodo de tiempo: During surgery
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blood lose
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During surgery
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Radiation dose
Periodo de tiempo: During surgery
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Radiation dose
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During surgery
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Complications
Periodo de tiempo: immediately after the surgery, up to 12 weeks
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Complications
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immediately after the surgery, up to 12 weeks
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Hospital stay
Periodo de tiempo: days between in and out hospital
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total hospital stay days
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days between in and out hospital
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Deviation of screw
Periodo de tiempo: up to 12 months
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The deviation between the actual position of screw and the preoperative designed position
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up to 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: tian wei, MD,PHD, Beijing Jishuitan Hospital
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 (Anticipado)
1 de junio de 2022
Finalización primaria (Anticipado)
1 de enero de 2023
Finalización del estudio (Anticipado)
1 de enero de 2025
Fechas de registro del estudio
Enviado por primera vez
14 de enero de 2021
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2022
Publicado por primera vez (Actual)
24 de mayo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
23 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- JST-202101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
not decided
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
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