Fusion of Spine (Disease)Phase 3NCT02890043
Clinical Trial for the Application of Tirobot System
A Phase 3 study testing robot-assisted spine surgery, free-hand surgery and TiRobot system in people with Fusion of Spine (Disease) and Robotic Surgical Procedures, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The object of this study was to evaluate the accuracy and safety of the Tirobot system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusion of Spine (Disease), Robotic Surgical Procedures
- What is being tested?
- robot-assisted spine surgery, free-hand surgery and TiRobot system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery
Who cannot join
- severe osteoporosis
- old thoracolumbar fracture
- deformity of pedicle
- combined with coagulation disorders
- combined with other systematic disease
Trial locations and contacts
1 site in 1 country.
About this study
The object of this study was to evaluate the accuracy and safety of the Tirobot system.
Read the detailed description
Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.
- Being tested
- robot-assisted spine surgery, free-hand surgery, TiRobot system
- Keywords
- spine, robot-assisted surgery, pedicle screw
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted spine surgeryProcedure or surgery
robot-assisted spine surgery using Tirobot system
free-hand surgeryProcedure or surgery
traditional free-hand surgery
TiRobot systemDevice
a robot-assisted spine surgery system
| Study group | Role | What they receive |
|---|---|---|
| Robot | Experimental | Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system Receives: Procedure: robot-assisted spine surgery; Device: TiRobot system |
| Free-hand | Active comparator | Intervention: Surgery: free-hand surgery Receives: Procedure: free-hand surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
perforation rate of pedicle screws
number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number
Measured: up to postoperative 3 days
Secondary outcomes (2)
operation time
total operation time of the surgery (time in minutes)
Measured: through the operation complete, an average of 2 hours
complications
Number of Adverse Events That Are Related to Treatments
Measured: up to postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fusion of Spine (Disease)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tinavi Medical Technology Co Ltd, Chinese PLA General Hospital, Tianjin Hospital
- Responsible party
- Principal investigator, Wei Tian, Beijing Jishuitan Hospital
- Investigators
- Wei Tian, MD, Study chair, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890043
- Sponsor's protocol ID
- JST-Tirobot-2016
- Status last verified
- Sep 2016
- First submitted
- 21 Aug 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
PubMed 21079498Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: is it safe? J Spinal Disord Tech. 2008 Feb;21(1):63-7. doi: 10.1097/BSD.0b013e3181453dc6.
PubMed 18418139Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46.
PubMed 1395312Han X, Tian W, Liu Y, Liu B, He D, Sun Y, Han X, Fan M, Zhao J, Xu Y, Zhang Q. Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial. J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1.
PubMed 30738398
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Application of Tirobot System
- ClinicalTrials.gov ID
- NCT02890043
- Acronym / sponsor ID
- JST-Tirobot-2016
- Keywords
- spine, robot-assisted surgery, pedicle screw
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Beijing Tinavi Medical Technology Co Ltd, Chinese PLA General Hospital, Tianjin Hospital
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 object of this study was to evaluate the accuracy and safety of the Tirobot system.
Detailed description
Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot | Experimental | Procedure: robot-assisted spine surgery, Device: TiRobot systemIntervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system |
| Free-hand | Active comparator | Procedure: free-hand surgeryIntervention: Surgery: free-hand surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery
Key exclusion criteria (5 listed)
- severe osteoporosis
- old thoracolumbar fracture
- deformity of pedicle
- combined with coagulation disorders
- combined with other systematic disease
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 |
|---|---|---|
| robot-assisted spine surgeryrobot-assisted spine surgery using Tirobot system | Procedure or surgery | Robot |
| free-hand surgerytraditional free-hand surgery | Procedure or surgery | Free-hand |
| TiRobot systema robot-assisted spine surgery system | Device | Robot |
Primary outcome
perforation rate of pedicle screws
Time frame: up to postoperative 3 days
number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number
2 secondary outcomes
operation time
Time frame: through the operation complete, an average of 2 hours
complications
Time frame: up to postoperative 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Results publication: PubMed 21079498Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
- Results publication: PubMed 18418139Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: is it safe? J Spinal Disord Tech. 2008 Feb;21(1):63-7. doi: 10.1097/BSD.0b013e3181453dc6.
- Results publication: PubMed 1395312Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46.
- Derived from this study: PubMed 30738398Han X, Tian W, Liu Y, Liu B, He D, Sun Y, Han X, Fan M, Zhao J, Xu Y, Zhang Q. Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial. J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1.
- Individual participant dataSharing planned: Undecided
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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 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 Phase 3 study testing robot-assisted spine surgery, free-hand surgery and TiRobot system in people with Fusion of Spine (Disease) and Robotic Surgical Procedures, 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 5 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: finished, as of the sponsor's last update on 12 Sep 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
perforation rate of pedicle screws (time frame: up to postoperative 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890043, which also lists 4 linked publications.
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 12 Sep 2016.