Lumbar Disc HerniationNCT05632835
Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
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 endoscopic spinal surgery 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, Radicular Pain
- 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
- 28 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to 31 Dec 2023
- 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 endoscopic spinal surgeries.
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 target as evidenced by computed tomography/magnetic resonance imaging;
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;
- Systemic infection;
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- Injection site infection;
- Unstable medical or psychiatric condition;
- Unable to tolerate the surgeries.
Trial locations and contacts
1 site in 1 country.
China1 site
Pain medicine center of Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Application of 3D printing guide plate in endoscopic spinal surgery
Read the detailed description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal 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 or evoked pain.
- Being tested
- 3D printing guide plate, Conventional guidance
- Keywords
- Endoscopic spinal surgeries, 3D printing guide plate
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, 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 endoscopic spinal surgeries to help to reduce intra-operative radiation, puncture time, etc..
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 endoscopic spinal 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
Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition
Measured: Postoperative 1 day, 2 weeks, 1 month
Patient satisfaction
Patient satisfaction using the modified MacNab criteria (MacNab)
Measured: Postoperative 1 months
Rate of Complications
Rate of Complications 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 posted1 Dec 2022
- Study start25 Nov 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT05632835
- Sponsor's protocol ID
- TTK04
- Status last verified
- Sep 2022
- First submitted
- 29 Oct 2022
- Last updated
- 1 Dec 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery
- ClinicalTrials.gov ID
- NCT05632835
- Acronym / sponsor ID
- TTK04
- Keywords
- Endoscopic spinal surgeries, 3D printing guide plate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Dec 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 endoscopic spinal surgery
Detailed description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal 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 or evoked pain.
Study design
- Primary purpose
- Other
- 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 endoscopic spinal 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 target 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 endoscopic spinal surgeries to help to reduce intra-operative radiation, puncture time, etc.. | 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
Time frame: Postoperative 1 day, 2 weeks, 1 month
Patient satisfaction
Time frame: Postoperative 1 months
Rate of 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 Dec 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.
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 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 Dec 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?
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?
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 Dec 2022.