Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

NCT05388383 | Unknown

• 1 other identifier: JST-202101
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spine Degeneration; Economic Problems; Surgery

Keywords

robot-assisted; spine surgery; cost-effectiveness

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• operation time

  During surgery

• blood lose

  During surgery

• Radiation dose

  During surgery

• Complications

  immediately after the surgery, up to 12 weeks

• Hospital stay

  days between in and out hospital

Study Arms (3)

free-hand

spine surgery without robot

robot-assisted

Robot-assisted open surgery

Device: Ti-robot

mi

Robot-assisted minimally invasive surgery

Device: Ti-robot

Interventions

Ti-robot DEVICE

Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital

mi; robot-assisted

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnose lumbar degenerative diseases and lumbar fractures
• single-level lumbar pedicle screw internal fixation
• Sign informed consent

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

Location

Study Officials

• tian wei, MD,PHD

  Beijing Jishuitan Hospital

  STUDY CHAIR

Central Study Contacts

mingxing fan, MD,PHD

CONTACT

+86-13683360600; van0208@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Spine department, Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: May 24, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2025
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CN (1)