Lumbar Spine DegenerationNCT05388383
Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
An observational study of Lumbar Spine Degeneration and Economic Problems, run by Beijing Jishuitan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Spine Degeneration, Economic Problems, Surgery
- What is being tested?
- Ti-robot
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who come to our hospital and meet the inclusion and exclusion criteria
Who may be able to join
- Diagnose lumbar degenerative diseases and lumbar fractures
- single-level lumbar pedicle screw internal fixation
- Sign informed consent
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Jishuitan hospital
Beijing, Beijing Municipality, 100000
Mingxing Fan, MD
About this study
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.
Read the 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.
- Conditions
- Lumbar Spine Degeneration, Economic Problems, Surgery
- Being tested
- Ti-robot
- Keywords
- robot-assisted, spine surgery, cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ti-robotDevice
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
| Study group | Role | What they receive |
|---|---|---|
| free-hand | spine surgery without robot | |
| robot-assisted | Robot-assisted open surgery Receives: Device: Ti-robot | |
| mi | Robot-assisted minimally invasive surgery Receives: Device: Ti-robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
COST
Perioperative cost
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (6)
operation time
operation time
Measured: During surgery
blood lose
blood lose
Measured: During surgery
Radiation dose
Radiation dose
Measured: During surgery
Complications
Complications
Measured: immediately after the surgery, up to 12 weeks
Hospital stay
total hospital stay days
Measured: days between in and out hospital
Deviation of screw
The deviation between the actual position of screw and the preoperative designed position
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Tian, Beijing Jishuitan Hospital
- Investigators
- tian wei, MD,PHD, Study chair, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388383
- Sponsor's protocol ID
- JST-202101
- Status last verified
- May 2022
- First submitted
- 14 Jan 2021
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
- ClinicalTrials.gov ID
- NCT05388383
- Acronym / sponsor ID
- JST-202101
- Conditions
- Lumbar Spine Degeneration, Economic Problems, Surgery
- Keywords
- robot-assisted, spine surgery, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| free-hand | – | –spine surgery without robot |
| robot-assisted | – | Device: Ti-robotRobot-assisted open surgery |
| mi | – | Device: Ti-robotRobot-assisted minimally invasive surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who come to our hospital and meet the inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- Diagnose lumbar degenerative diseases and lumbar fractures
- single-level lumbar pedicle screw internal fixation
- Sign informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ti-robotTianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital | Device | mi, robot-assisted |
Primary outcome
COST
Time frame: Up to 12 months
Perioperative cost
Visual Analogue Scale
Time frame: Up to 12 months
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.
Oswestry Disability Index
Time frame: Up to 12 months
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.
modified Japanese orthopaedic association score
Time frame: Up to 12 months
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.
SF-36(Medical Outcomes Study Short-Form 36)
Time frame: Up to 12 months
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.
6 secondary outcomes
operation time
Time frame: During surgery
blood lose
Time frame: During surgery
Radiation dose
Time frame: During surgery
Complications
Time frame: immediately after the surgery, up to 12 weeks
Hospital stay
Time frame: days between in and out hospital
Deviation of screw
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided. not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tian wei, MD,PHD study chair
Beijing Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Degeneration and Economic Problems, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mingxing fan, MD,PHD (+86-13683360600, van0208@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COST (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.