Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lumbar Spine Degeneration Economic Problems Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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free-hand

spine surgery without robot

No interventions assigned to this group

robot-assisted

Robot-assisted open surgery

Ti-robot

Intervention Type DEVICE

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

mi

Robot-assisted minimally invasive surgery

Ti-robot

Intervention Type DEVICE

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

Interventions

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Ti-robot

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

Intervention Type DEVICE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No