Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: mingxing fan, MD,PHD
- Número de telefone: +86-13683360600
- E-mail: van0208@163.com
Locais de estudo
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Beijing
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Beijing, Beijing, China, 100000
- Beijing Jishuitan Hospital
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Contato:
- Mingxing Fan, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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COST
Prazo: 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
Prazo: Up to 12 months
|
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
Prazo: 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
Prazo: 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.
|
Up to 12 months
|
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SF-36(Medical Outcomes Study Short-Form 36)
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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operation time
Prazo: During surgery
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operation time
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During surgery
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blood lose
Prazo: During surgery
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blood lose
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During surgery
|
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Radiation dose
Prazo: During surgery
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Radiation dose
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During surgery
|
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Complications
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Investigadores
- Cadeira de estudo: tian wei, MD,PHD, Beijing Jishuitan Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- JST-202101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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