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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: mingxing fan, MD,PHD
- Telefonní číslo: +86-13683360600
- E-mail: van0208@163.com
Studijní místa
-
-
Beijing
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Beijing, Beijing, Čína, 100000
- Beijing Jishuitan Hospital
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Kontakt:
- Mingxing Fan, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
|
|
mi
Robot-assisted minimally invasive surgery
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Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
COST
Časové okno: Up to 12 months
|
Perioperative cost
|
Up to 12 months
|
|
Visual Analogue Scale
Časové okno: 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.
|
Up to 12 months
|
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Oswestry Disability Index
Časové okno: Up to 12 months
|
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.
|
Up to 12 months
|
|
modified Japanese orthopaedic association score
Časové okno: 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.
|
Up to 12 months
|
|
SF-36(Medical Outcomes Study Short-Form 36)
Časové okno: 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.
|
Up to 12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
operation time
Časové okno: During surgery
|
operation time
|
During surgery
|
|
blood lose
Časové okno: During surgery
|
blood lose
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During surgery
|
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Radiation dose
Časové okno: During surgery
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Radiation dose
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During surgery
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Complications
Časové okno: 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
Časové okno: 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
Časové okno: up to 12 months
|
The deviation between the actual position of screw and the preoperative designed position
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up to 12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: tian wei, MD,PHD, Beijing Jishuitan Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- JST-202101
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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