Spine DiseasePhase 3NCT04956588
Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
A Phase 3 study testing surgical robot in people with Spine Disease and Spinal Fractures, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Disease, Spinal Fractures
- What is being tested?
- surgical robot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.
Who cannot join
- Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial to Evaluate the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.
- Conditions
- Spine Disease, Spinal Fractures
- Being tested
- surgical robot, controlled approach
- Keywords
- smart orthopedics, minimally invasive surgical systems, spinal surgery
- Medical subject headings
- Spinal Diseases, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical robotCombination product
The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.
controlled approachCombination product
The screw placement was performed using a controlled approach according to the surgical plan.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Combination Product: surgical robot |
| control group | Active comparator | Not described Receives: Combination Product: controlled approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incorrect placement of guide pin
After the subject completes the preparation for guide needle placement (e.g. reduction), a C-arm scan is performed. Get the image. Surgical planning is performed on images. Control robot positioning. The doctor completes the insertion of the guide needle. Then the C-arm scan image was obtained again. Fusion of two groups of images on a third-party software. The deviation distance between the entry and exit points of the guide needle and the surgical plan was measured. The accuracy of guide needle placement was evaluated by the deviation of guide needle placement.
Measured: During operation
Number of X-ray exposures
The number of exposures was defined as the number of times the investigator used the X-ray during the operative period and also included the number of exposures performed to determine the surgical site.
Measured: During operation
X-ray exposure time
X-ray exposure time refers to the total time of using X-rays from the planning of the operation to the end of the operation.
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Second People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956588
- Sponsor's protocol ID
- D2017079
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial to Evaluate the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
- ClinicalTrials.gov ID
- NCT04956588
- Acronym / sponsor ID
- D2017079
- Conditions
- Spine Disease, Spinal Fractures
- Keywords
- smart orthopedics, minimally invasive surgical systems, spinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Second People's Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2021 (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.
To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: surgical robot |
| control group | Active comparator | Combination Product: controlled approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.
Key exclusion criteria (1 listed)
- Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.
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 |
|---|---|---|
| surgical robotThe surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process. | Combination product | experimental group |
| controlled approachThe screw placement was performed using a controlled approach according to the surgical plan. | Combination product | control group |
Primary outcome
Incorrect placement of guide pin
Time frame: During operation
After the subject completes the preparation for guide needle placement (e.g. reduction), a C-arm scan is performed. Get the image. Surgical planning is performed on images. Control robot positioning. The doctor completes the insertion of the guide needle. Then the C-arm scan image was obtained again. Fusion of two groups of images on a third-party software. The deviation distance between the entry and exit points of the guide needle and the surgical plan was measured. The accuracy of guide needle placement was evaluated by the deviation of guide needle placement.
Number of X-ray exposures
Time frame: During operation
The number of exposures was defined as the number of times the investigator used the X-ray during the operative period and also included the number of exposures performed to determine the surgical site.
X-ray exposure time
Time frame: During operation
X-ray exposure time refers to the total time of using X-rays from the planning of the operation to the end of the operation.
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 9 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 surgical robot in people with Spine Disease and Spinal Fractures, run by Peking University Third 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: finished, as of the sponsor's last update on 9 Jul 2021. 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?
Incorrect placement of guide pin (time frame: During operation). The study lists 3 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 9 Jul 2021.