Vertebral FractureNCT04980131
Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator
A study testing Pointed lotus root regulator and guide template aided PPSF and Flat ended lotus root regulator and guide template aided PPSF in people with Vertebral Fracture, run by Ming Zhang at 1 site in China.
Trial summary
This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- Pointed lotus root regulator and guide template aided PPSF and Flat ended lotus root regulator and guide template aided PPSF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2018to 30 Jun 2020
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
- The vertebral fracture sites where are located in T11-L2
- No clinical neurological symptoms and signs
- The patients who have complete preoperative X-ray, CT, MRI and other imaging data
Who cannot join
- Vertebral burst fracture with spinal canal occupation
- Fracture caused by severe osteoporosis or tumor and other pathological factors
- Moderate and severe scoliosis
- Patients with pedicle dysplasia
- Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
- Coagulation dysfunction or surgical site of the skin infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures
This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.
Read the detailed description
All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.
- Conditions
- Vertebral Fracture
- Being tested
- Pointed lotus root regulator and guide template aided PPSF, Flat ended lotus root regulator and guide template aided PPSF
- Keywords
- 3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pointed lotus root regulator and guide template aided PPSFDevice
20 patients in group C received PPSF with pointed lotus-style regulator
Flat ended lotus root regulator and guide template aided PPSFDevice
20 patients in group B received PPSF with flat ended lotus-style regulator
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | Group C were received PPSF with pointed lotus-style regulator Receives: Device: Pointed lotus root regulator and guide template aided PPSF |
| Group B | Experimental | Group B were received PPSF with Flat ended lotus root regulator Receives: Device: Flat ended lotus root regulator and guide template aided PPSF |
| Group A | No intervention | Group A were received traditional PPSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position
All the operations were successfully completed. The number of pedicles successfully first pierced in group C was higher than that in group A and group B (P<0.05);The number of insertion, fluoroscopy and operation time before the insertion needle reached the ideal position, the total number and time of intraoperative fluoroscopy, and the intraoperative blood loss in group C were all significantly lower than those of group A and group B (P<0.05)
Measured: twenty months
VAS scores after surgery
All patients were followed up 6 months after surgery. VAS scores at 1 day and 7 days after surgery were higher in Group A than those in other groups（P<0.05）, but no differences were found VAS scores at 1 , 3 and 6 months after surgery in 3 groups.Specific methods: drawing a 10cm line on the paper, one end of the horizontal line is 0, that is painless; The other end is 10, which means severe pain; The intermediate part indicates different levels of pain. Asking the patient to mark the level of pain on a horizontal line according to how he or she feels. 0-2: meaning comfortable; 3-4: slight discomfort; 5-6: moderate discomfort; 7-8: Severe discomfort;9-10: Extreme discomfort.
Measured: twenty-two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start6 Jun 2018
- Primary completion28 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ming Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an
- Responsible party
- Sponsor-investigator, Ming Zhang, The Second People's Hospital of Huai'an
- Investigators
- Quan Zhou, Zhou, Study director, The Second People's Hospital of Huai'an
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980131
- Sponsor's protocol ID
- HEYLL201705
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Wait for the results of related parallel trials before considering sharing data
Publications
Zhang M, Li J, Fang T, Zhao J, Pan W, Wang X, Xu J, Zhou Q. Evaluation of a Three-Dimensional Printed Guide and a Polyoxymethylene Thermoplastic Regulator for Percutaneous Pedicle Screw Fixation in Patients with Thoracolumbar Fracture. Med Sci Monit. 2020 Jan 14;26:e920578. doi: 10.12659/MSM.920578.
PubMed 31932574Zhang M, Li J, Fang T, Yan J, Wu L, Zhou Q. Application of 3-dimensional printing guide template and pointed lotus-style regulator in percutaneous pedicle screw fixation for thoracolumbar fractures. Sci Rep. 2022 Feb 21;12(1):2930. doi: 10.1038/s41598-022-06256-x.
PubMed 35190566
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures
- ClinicalTrials.gov ID
- NCT04980131
- Acronym / sponsor ID
- HEYLL201705
- Conditions
- Vertebral Fracture
- Keywords
- 3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ming ZhangUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 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.
This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.
Detailed description
All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Device: Pointed lotus root regulator and guide template aided PPSFGroup C were received PPSF with pointed lotus-style regulator |
| Group B | Experimental | Device: Flat ended lotus root regulator and guide template aided PPSFGroup B were received PPSF with Flat ended lotus root regulator |
| Group A | No intervention | –Group A were received traditional PPSF |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
- The vertebral fracture sites where are located in T11-L2
- No clinical neurological symptoms and signs
- The patients who have complete preoperative X-ray, CT, MRI and other imaging data
Key exclusion criteria (6 listed)
- Vertebral burst fracture with spinal canal occupation
- Fracture caused by severe osteoporosis or tumor and other pathological factors
- Moderate and severe scoliosis
- Patients with pedicle dysplasia
- Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
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 |
|---|---|---|
| Pointed lotus root regulator and guide template aided PPSF20 patients in group C received PPSF with pointed lotus-style regulator | Device | Group C |
| Flat ended lotus root regulator and guide template aided PPSF20 patients in group B received PPSF with flat ended lotus-style regulator | Device | Group B |
Primary outcome
First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position
Time frame: twenty months
All the operations were successfully completed. The number of pedicles successfully first pierced in group C was higher than that in group A and group B (P<0.05);The number of insertion, fluoroscopy and operation time before the insertion needle reached the ideal position, the total number and time of intraoperative fluoroscopy, and the intraoperative blood loss in group C were all significantly lower than those of group A and group B (P<0.05)
VAS scores after surgery
Time frame: twenty-two months
All patients were followed up 6 months after surgery. VAS scores at 1 day and 7 days after surgery were higher in Group A than those in other groups（P<0.05）, but no differences were found VAS scores at 1 , 3 and 6 months after surgery in 3 groups.Specific methods: drawing a 10cm line on the paper, one end of the horizontal line is 0, that is painless; The other end is 10, which means severe pain; The intermediate part indicates different levels of pain. Asking the patient to mark the level of pain on a horizontal line according to how he or she feels. 0-2: meaning comfortable; 3-4: slight discomfort; 5-6: moderate discomfort; 7-8: Severe discomfort;9-10: Extreme discomfort.
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 28 Jul 2021.
- Results publication: PubMed 31932574Zhang M, Li J, Fang T, Zhao J, Pan W, Wang X, Xu J, Zhou Q. Evaluation of a Three-Dimensional Printed Guide and a Polyoxymethylene Thermoplastic Regulator for Percutaneous Pedicle Screw Fixation in Patients with Thoracolumbar Fracture. Med Sci Monit. 2020 Jan 14;26:e920578. doi: 10.12659/MSM.920578.
- Derived from this study: PubMed 35190566Zhang M, Li J, Fang T, Yan J, Wu L, Zhou Q. Application of 3-dimensional printing guide template and pointed lotus-style regulator in percutaneous pedicle screw fixation for thoracolumbar fractures. Sci Rep. 2022 Feb 21;12(1):2930. doi: 10.1038/s41598-022-06256-x.
- This work is licensed under Creative Common AttributionNonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Wait for the results of related parallel trials before considering sharing data
Related trials for Vertebral Fracture
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruiting
StUdy oN Burst Fractures (SunBurst)
Thoracolumbar Burst Fracture
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
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.
Quan Zhou, Zhou study director
The Second People's Hospital of Huai'an
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pointed lotus root regulator and guide template aided PPSF and Flat ended lotus root regulator and guide template aided PPSF in people with Vertebral Fracture, run by Ming Zhang 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 4 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: finished, as of the sponsor's last update on 28 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.
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?
First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position (time frame: twenty months). The study lists 2 primary outcomes in all. 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 NCT04980131, which also lists 2 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 28 Jul 2021.