Robotic Surgical ProceduresNCT03512379
Clinical Trial for the Application of Robotic System in Spinal Surgery
A study testing TIANJI Robot, Fluoroscopy and Navigation in people with Robotic Surgical Procedures and Spinal Surgery, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Robotic Surgical Procedures, Spinal Surgery, Safety
- What is being tested?
- TIANJI Robot, Fluoroscopy and Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2015to 31 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spinal disease required for screw fixation；signed the inform consent
Who cannot join
- Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Weijun Zhang, MD, 010-82156660, zhangweijun@tinavi.com
About this study
Official title: Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
Read the detailed description
Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.
- Conditions
- Robotic Surgical Procedures, Spinal Surgery, Safety
- Being tested
- TIANJI Robot, Fluoroscopy, Navigation
- Keywords
- robot-assisted surgery, pedicle screw, spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIANJI RobotDevice
A robotic system for spinal surgery
FluoroscopyDevice
For fluoroscopy-based free hand surgery
NavigationDevice
For navigation-assisted spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted surgery group | Experimental | Spinal surgery using TIANJI Robot system. Receives: Device: TIANJI Robot |
| Free hand surgery group | Active comparator | Spinal surgery using fluoroscopy-based free hand technique Receives: Device: Fluoroscopy |
| Navigation-assisted surgery group | Active comparator | Spinal surgery using Navigation-assisted technique Receives: Device: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw guide wire adjustment times
The adjustment times of screw guide wire during surgery
Measured: During surgery
Screw adjustment times
The adjustment times of screw during surgery
Measured: During surgery
Deviation of screw
The deviation between the actual position of screw and the preoperative designed position
Measured: Up to 12 weeks
Perforation rate of screw
Rate of screws breaching out pedicles on postoperative CT image
Measured: Up to 12 weeks
Secondary outcomes (13)
Operation time
Operation time
Measured: During surgery
Blood loss
Blood loss during surgery
Measured: During surgery
Complications
Complications after surgery
Measured: Up to 4 weeks
Hospital stay after surgery
Hospital stay after surgery
Measured: Up to 4 weeks
Hospitalization costs
Hospitalization costs
Measured: Up to 4 weeks
Visual Analogue Scale
Visual Analogue Scale
Measured: 3 days before surgery
Visual Analogue Scale
Visual Analogue Scale
Measured: 3 days after surgery
Neck Disability Index
Neck Disability Index
Measured: 3 days before surgery
Neck Disability Index
Neck Disability Index
Measured: 3 days after surgery
Oswestry Disability Index
Oswestry Disability Index
Measured: 3 days before surgery
Oswestry Disability Index
Oswestry Disability Index
Measured: 3 days after surgery
modified Japanese orthopaedic association score
modified Japanese orthopaedic association score
Measured: 3 days before surgery
modified Japanese orthopaedic association score
modified Japanese orthopaedic association score
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Aug 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies 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
- Model description
- Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 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
- Wei Tian, MD,PHD, Study chair, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512379
- Sponsor's protocol ID
- JST-201508
- Status last verified
- Sep 2018
- First submitted
- 3 Apr 2018
- Last updated
- 24 Sep 2018
- 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 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03512379
- Acronym / sponsor ID
- JST-201508
- Conditions
- Robotic Surgical Procedures, Spinal Surgery, Safety
- Keywords
- robot-assisted surgery, pedicle screw, spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Apr 2018 (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.
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
Detailed description
Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
| Arm | Type | Receives |
|---|---|---|
| Robot assisted surgery group | Experimental | Device: TIANJI RobotSpinal surgery using TIANJI Robot system. |
| Free hand surgery group | Active comparator | Device: FluoroscopySpinal surgery using fluoroscopy-based free hand technique |
| Navigation-assisted surgery group | Active comparator | Device: NavigationSpinal surgery using Navigation-assisted technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Spinal disease required for screw fixation；signed the inform consent
Key exclusion criteria (1 listed)
- Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.
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 |
|---|---|---|
| TIANJI RobotA robotic system for spinal surgery | Device | Robot assisted surgery group |
| FluoroscopyFor fluoroscopy-based free hand surgery | Device | Free hand surgery group |
| NavigationFor navigation-assisted spinal surgery | Device | Navigation-assisted surgery group |
Primary outcome
Screw guide wire adjustment times
Time frame: During surgery
The adjustment times of screw guide wire during surgery
Screw adjustment times
Time frame: During surgery
The adjustment times of screw during surgery
Deviation of screw
Time frame: Up to 12 weeks
The deviation between the actual position of screw and the preoperative designed position
Perforation rate of screw
Time frame: Up to 12 weeks
Rate of screws breaching out pedicles on postoperative CT image
13 secondary outcomes
Operation time
Time frame: During surgery
Blood loss
Time frame: During surgery
Complications
Time frame: Up to 4 weeks
Hospital stay after surgery
Time frame: Up to 4 weeks
Hospitalization costs
Time frame: Up to 4 weeks
Visual Analogue Scale
Time frame: 3 days before surgery
Visual Analogue Scale
Time frame: 3 days after surgery
Neck Disability Index
Time frame: 3 days before surgery
Neck Disability Index
Time frame: 3 days after surgery
Oswestry Disability Index
Time frame: 3 days before surgery
Oswestry Disability Index
Time frame: 3 days after surgery
modified Japanese orthopaedic association score
Time frame: 3 days before surgery
modified Japanese orthopaedic association score
Time frame: 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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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.
Wei Tian, 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?
A study testing TIANJI Robot, Fluoroscopy and Navigation in people with Robotic Surgical Procedures and Spinal Surgery, 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 1 inclusion and 1 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 Sep 2018. 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?
Screw guide wire adjustment times (time frame: During surgery). The study lists 4 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 Sep 2018.