Lumbar Disc HerniationNCT05487690
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
A study testing 3D printing guide plate and Conventional guidance in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy
- What is being tested?
- 3D printing guide plate and Conventional guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to 31 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old,
- Pain lasting ≥12 weeks,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
- Agree with spinal minimally invasive and interventional surgery treatments, including endoscopic spinal surgery, radiofrequency treatment of the medial branch of the dorsal ramus or nerve root or sensory ganglion or joint, disc coblation nucleoplasty, etc.
Who cannot join
- Patient refusal to participate in the study,
- Pregnant or nursing
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
- Steroid injection within the previous 12 weeks,
Show all 9Show fewer
- Systemic infection,
- Injection site infection,
- Unstable medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
China1 site
Pain medicine center of Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shuiqing Li, MD, 01082266699, bjfdfx@126.com
Qipeng Luo, MD, 01082265026, 1293194276@qq.com
About this study
Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries
Read the detailed description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgery, radiofrequency ablation of the medial branch of the dorsal ramus or sensory ganglion or joint, disc coblation nucleoplasty, etc. in patients with low back pain, lumbosacral radicular pain, joint pain, perineal pain and pelvic pain. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved lumbar disc herniation (LDH), lumbar spinal stenosis (LCS), radiculopathy, facet joint disorder syndrome, ischemic pain of the lower extremity, cancer pain, etc.. Spinal minimally invasive and interventional surgeries are effective treatments for these disease. Needle Puncture is the key technology in spinal minimally invasive and interventional surgeries.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.
The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy, Lumbosacral Facet Joint Syndrome, Ischemic Pain of the Lower Extremity, Spinal Minimally Invasive and Interventional Surgeries
- Being tested
- 3D printing guide plate, Conventional guidance
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing guide plateOther
3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. to help to reduce intra-operative radiation.
Conventional guidanceOther
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
| Study group | Role | What they receive |
|---|---|---|
| 3D printing guide plate group | Experimental | 3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. Receives: Other: 3D printing guide plate |
| Conventional guidance group | Active comparator | The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. Receives: Other: Conventional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-arm fluoroscopy times
Numbers of using C-arm fluoroscopy
Measured: Intraoperative
Secondary outcomes (4)
Puncture time
Time from the first puncture to the last puncture
Measured: Intraoperative
Numerical rating scale (NRS)
NRS at 1 day, 2 weeks, 1 month after the operation
Measured: Postoperative 1 day, 2 weeks, 1 month
MacNab
Patient satisfaction using the modified MacNab criteria
Measured: Postoperative 1 months
Complications
Complication like nerve injury, blood, hemotoma, etc.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start20 Oct 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487690
- Sponsor's protocol ID
- TTK02
- Status last verified
- Jul 2022
- First submitted
- 2 Aug 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
- ClinicalTrials.gov ID
- NCT05487690
- Acronym / sponsor ID
- TTK02
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy, Lumbosacral Facet Joint Syndrome, Ischemic Pain of the Lower Extremity, Spinal Minimally Invasive and Interventional Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 4 Aug 2022 (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.
Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries
Detailed description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgery, radiofrequency ablation of the medial branch of the dorsal ramus or sensory ganglion or joint, disc coblation nucleoplasty, etc. in patients with low back pain, lumbosacral radicular pain, joint pain, perineal pain and pelvic pain. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved lumbar disc herniation (LDH), lumbar spinal stenosis (LCS), radiculopathy, facet joint disorder syndrome, ischemic pain of the lower extremity, cancer pain, etc.. Spinal minimally invasive and interventional surgeries are effective treatments for these disease. Needle Puncture is the key technology in spinal minimally invasive and interventional surgeries.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.
The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing guide plate group | Experimental | Other: 3D printing guide plate3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. |
| Conventional guidance group | Active comparator | Other: Conventional guidanceThe surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old,
- Pain lasting ≥12 weeks,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
Key exclusion criteria (9 listed)
- Patient refusal to participate in the study,
- Pregnant or nursing
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
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 |
|---|---|---|
| 3D printing guide plate3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. to help to reduce intra-operative radiation. | Other | 3D printing guide plate group |
| Conventional guidanceThe surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. | Other | Conventional guidance group |
Primary outcome
C-arm fluoroscopy times
Time frame: Intraoperative
Numbers of using C-arm fluoroscopy
4 secondary outcomes
Puncture time
Time frame: Intraoperative
Numerical rating scale (NRS)
Time frame: Postoperative 1 day, 2 weeks, 1 month
MacNab
Time frame: Postoperative 1 months
Complications
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing guide plate and Conventional guidance in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, 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 6 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 1 Nov 2022. 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 Shuiqing Li (+86 01082265690, bjfdfx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-arm fluoroscopy times (time frame: Intraoperative). 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 1 Nov 2022.