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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: mingxing fan, MD,PHD
- Numero di telefono: +86-13683360600
- Email: van0208@163.com
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 100000
- Beijing Jishuitan Hospital
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Contatto:
- Mingxing Fan, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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COST
Lasso di tempo: Up to 12 months
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Perioperative cost
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Up to 12 months
|
|
Visual Analogue Scale
Lasso di tempo: 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
Lasso di tempo: 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
|
|
modified Japanese orthopaedic association score
Lasso di tempo: Up to 12 months
|
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
|
|
SF-36(Medical Outcomes Study Short-Form 36)
Lasso di tempo: Up to 12 months
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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operation time
Lasso di tempo: During surgery
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operation time
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During surgery
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blood lose
Lasso di tempo: During surgery
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blood lose
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During surgery
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Radiation dose
Lasso di tempo: During surgery
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Radiation dose
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During surgery
|
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Complications
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: tian wei, MD,PHD, Beijing Jishuitan Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- JST-202101
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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