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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: mingxing fan, MD,PHD
- Telefoonnummer: +86-13683360600
- E-mail: van0208@163.com
Studie Locaties
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Beijing Jishuitan Hospital
-
Contact:
- Mingxing Fan, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
free-hand
spine surgery without robot
|
|
|
robot-assisted
Robot-assisted open surgery
|
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
|
|
mi
Robot-assisted minimally invasive surgery
|
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
COST
Tijdsspanne: Up to 12 months
|
Perioperative cost
|
Up to 12 months
|
|
Visual Analogue Scale
Tijdsspanne: 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
|
|
Oswestry Disability Index
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
operation time
Tijdsspanne: During surgery
|
operation time
|
During surgery
|
|
blood lose
Tijdsspanne: During surgery
|
blood lose
|
During surgery
|
|
Radiation dose
Tijdsspanne: During surgery
|
Radiation dose
|
During surgery
|
|
Complications
Tijdsspanne: immediately after the surgery, up to 12 weeks
|
Complications
|
immediately after the surgery, up to 12 weeks
|
|
Hospital stay
Tijdsspanne: days between in and out hospital
|
total hospital stay days
|
days between in and out hospital
|
|
Deviation of screw
Tijdsspanne: up to 12 months
|
The deviation between the actual position of screw and the preoperative designed position
|
up to 12 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: tian wei, MD,PHD, Beijing Jishuitan Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- JST-202101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .