Clinical trial NCT05388383: Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
Official title: Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spine Degeneration
Economic Problems
Surgery
Keywords: robot-assisted
spine surgery
cost-effectiveness
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who come to our hospital and meet the inclusion and exclusion criteria

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: COST
timeFrame: Up to 12 months
measure: Visual Analogue Scale
timeFrame: Up to 12 months
measure: Oswestry Disability Index
timeFrame: Up to 12 months
measure: modified Japanese orthopaedic association score
timeFrame: Up to 12 months
measure: SF-36(Medical Outcomes Study Short-Form 36)
timeFrame: Up to 12 months
Secondary outcomes:
measure: operation time
timeFrame: During surgery
measure: blood lose
timeFrame: During surgery
measure: Radiation dose
timeFrame: During surgery
measure: Complications
timeFrame: immediately after the surgery, up to 12 weeks
measure: Hospital stay
timeFrame: days between in and out hospital
measure: Deviation of screw
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: tian wei, MD,PHD
role: STUDY_CHAIR
References: