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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Lumbar Spine Degeneration; Economic Problems
• Intervention / Treatment: Device: Ti-robot

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: mingxing fan, MD,PHD; Phone Number: +86-13683360600; Email: van0208@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Jishuitan Hospital
      • Contact: Mingxing Fan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
free-hand; spine surgery without robot
robot-assisted; Robot-assisted open surgery	Device: Ti-robot; Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
mi; Robot-assisted minimally invasive surgery	Device: Ti-robot; Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COST	Perioperative cost	Up to 12 months
Visual Analogue Scale	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	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	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)	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Study Chair: tian wei, MD,PHD, Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cost-effectiveness; spine surgery; robot-assisted
• Other Study ID Numbers: JST-202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No