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Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

23. maj 2022 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: mingxing fan, MD,PHD
  • Telefonnummer: +86-13683360600
  • E-mail: van0208@163.com

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100000
        • Beijing Jishuitan hospital
        • Kontakt:
          • Mingxing Fan, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who come to our hospital and meet the inclusion and exclusion criteria

Beskrivelse

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.)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
free-hand
spine surgery without robot
robot-assisted
Robot-assisted open surgery
Enhed: Ti-robot
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
mi
Robot-assisted minimally invasive surgery
Enhed: Ti-robot
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
COST
Tidsramme: Up to 12 months
Perioperative cost
Up to 12 months
Visual Analogue Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
operation time
Tidsramme: During surgery
operation time
During surgery
blood lose
Tidsramme: During surgery
blood lose
During surgery
Radiation dose
Tidsramme: During surgery
Radiation dose
During surgery
Complications
Tidsramme: immediately after the surgery, up to 12 weeks
Complications
immediately after the surgery, up to 12 weeks
Hospital stay
Tidsramme: days between in and out hospital
total hospital stay days
days between in and out hospital
Deviation of screw
Tidsramme: up to 12 months
The deviation between the actual position of screw and the preoperative designed position
up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Jishuitan Hospital

Efterforskere

  • Studiestol: tian wei, MD,PHD, Beijing Jishuitan hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juni 2022

Primær færdiggørelse (Forventet)

1. januar 2023

Studieafslutning (Forventet)

1. januar 2025

Datoer for studieregistrering

Først indsendt

14. januar 2021

Først indsendt, der opfyldte QC-kriterier

23. maj 2022

Først opslået (Faktiske)

24. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • JST-202101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

not decided

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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