SurgeryNCT06416631
Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery
A study testing artificial intelligence based screw planning and manually screw planning in people with Surgery, run by Beijing Jishuitan Hospital.
Trial summary
The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are: Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- artificial intelligence based screw planning and manually screw planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2024to 1 May 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission to one of the participating centers；
- Need for and start of robotic spinal surgery
- Patients had complete medical records and imaging data;
Who cannot join
- Age less than 18 years;
- Patients with severe comorbidities;
- Patients diagnosed with tumor diseases;
- Inability to carry out the intervention (mental of physical conditions that limited participation);
- Patients with morbid obesity (body mass index > 40);
- Missing medical records and imaging data;
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- Patients with suspected or confirmed pregnancy;
- Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome;
- No informed consent.
About this study
Official title: Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study
The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are:
Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical accuracy？ Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery.
Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group.
Read the detailed description
Study design:
multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery.
Monitoring:
Monitoring of patient's safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board (DSMB). The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.
Sample Size Calculation:
Group size calculation is focused on demonstrating non-inferiority. Assuming that the percentage of clinically acceptable screws would be 90% in the artificial intelligence planning group and 95% in the manual planning group, with a non-inferiority margin of 10% and a one-sided significance level of 2.5%, we calculated that a sample of 79 screws per treatment group would give the trial approximately 95% power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point.
- Conditions
- Surgery
- Being tested
- artificial intelligence based screw planning, manually screw planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence based screw planningProcedure or surgery
artificial intelligence technology helps to plan screws in robot assisted spinal surgery
manually screw planningProcedure or surgery
the screw trajcetories are manually planned
| Study group | Role | What they receive |
|---|---|---|
| artificial intelligence planning group | Experimental | Not described Receives: Procedure: artificial intelligence based screw planning |
| manual planning group | Placebo comparator | Not described Receives: Procedure: manually screw planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of screw positioning or placement
according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach <2 mm), grade C (pedicle cortical breach <4 mm), grade D (pedicle cortical breach <6 mm), and grade E (pedicle cortical breach >6 mm). Grade A + B were considered clinically acceptable. The percentage of clinically acceptable screws was recorded.
Measured: 1 month
Secondary outcomes (2)
The planning time
Time from start to finish of planning
Measured: 1 day
postoperative complication
Nerve injury, epidural hematoma, and infection
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start25 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416631
- Sponsor's protocol ID
- AI-RASS
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT06416631
- Acronym / sponsor ID
- AI-RASS
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 25 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 May 2024 (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.
The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are:
Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical accuracy？ Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery.
Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group.
Detailed description
Study design:
multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery.
Monitoring:
Monitoring of patient's safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board (DSMB). The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.
Sample Size Calculation:
Group size calculation is focused on demonstrating non-inferiority. Assuming that the percentage of clinically acceptable screws would be 90% in the artificial intelligence planning group and 95% in the manual planning group, with a non-inferiority margin of 10% and a one-sided significance level of 2.5%, we calculated that a sample of 79 screws per treatment group would give the trial approximately 95% power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artificial intelligence planning group | Experimental | Procedure: artificial intelligence based screw planning |
| manual planning group | Placebo comparator | Procedure: manually screw planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to one of the participating centers；
- Need for and start of robotic spinal surgery
- Patients had complete medical records and imaging data;
Key exclusion criteria (9 listed)
- Age less than 18 years;
- Patients with severe comorbidities;
- Patients diagnosed with tumor diseases;
- Inability to carry out the intervention (mental of physical conditions that limited participation);
- Patients with morbid obesity (body mass index > 40);
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 |
|---|---|---|
| artificial intelligence based screw planningartificial intelligence technology helps to plan screws in robot assisted spinal surgery | Procedure or surgery | artificial intelligence planning group |
| manually screw planningthe screw trajcetories are manually planned | Procedure or surgery | manual planning group |
Primary outcome
The accuracy of screw positioning or placement
Time frame: 1 month
according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach <2 mm), grade C (pedicle cortical breach <4 mm), grade D (pedicle cortical breach <6 mm), and grade E (pedicle cortical breach >6 mm). Grade A + B were considered clinically acceptable. The percentage of clinically acceptable screws was recorded.
2 secondary outcomes
The planning time
Time frame: 1 day
postoperative complication
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligence based screw planning and manually screw planning in people with Surgery, run by Beijing Jishuitan Hospital.
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 9 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of screw positioning or placement (time frame: 1 month). 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 16 May 2024.