Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

Surgery Clinical Trial

Official title:

Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05388383
• Other study ID #: JST-202101
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2022
• Source: Beijing Jishuitan Hospital
• Contact: mingxing fan, MD,PHD
• Phone: +86-13683360600
• Email: van0208[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Economic Problems
• Lumbar Spine Degeneration
• Surgery

Intervention

Device:
• Ti-robot
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COST	Perioperative cost	Up to 12 months
Primary	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
Primary	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
Primary	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
Primary	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	operation time	operation time	During surgery
Secondary	blood lose	blood lose	During surgery
Secondary	Radiation dose	Radiation dose	During surgery
Secondary	Complications	Complications	immediately after the surgery, up to 12 weeks
Secondary	Hospital stay	total hospital stay days	days between in and out hospital
Secondary	Deviation of screw	The deviation between the actual position of screw and the preoperative designed position	up to 12 months