- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610553
Application of 3D Printing Guide Plate in Percutaneous Disc Decompression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study applies 3D-printed customized guide plate in assisting the accurate puncture in percutaneous disc decompression, in patients with low back pain, lumbosacral radicular pain, disogenic pain, lumbar disc herniation, disc degeneration, 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 (LDH), disc degeneration, etc. Percutaneous disc decompression surgeries are effective treatments for these disease. Needle Puncture is the key technology in percutaneous disc decompression 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100191
- Pain medicine center of Peking University Third Hospital
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Contact:
- Shuiqing Li, MD
- Phone Number: 01082266699
- Email: bjfdfx@126.com
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Contact:
- Qipeng Luo, MD
- Phone Number: 01082265026
- Email: 1293194276@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 percutaneous disc decompression.
Exclusion Criteria:
- 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;
- Injection site infection;
- Unstable medical or psychiatric condition;
- Unable to tolerate the surgeries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D printing guide plate group
3D-printed customized guide plate will be used to guide the puncture in percutaneous disc decompression surgeries.
|
3D-printed customized guide plate will be used to guide the puncture in percutaneous disc decompression surgeries to help to reduce intra-operative radiation, puncture time, etc..
|
Active Comparator: Conventional guidance group
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
|
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-arm fluoroscopy times
Time Frame: Intraoperative
|
Numbers of using C-arm fluoroscopy
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Puncture time
Time Frame: Intraoperative
|
Time from the first puncture to the last puncture
|
Intraoperative
|
Numerical rating scale (NRS)
Time Frame: Postoperative 1 day, 2 weeks, 1 month
|
NRS at 1 day, 2 weeks, 1 month after the operation
|
Postoperative 1 day, 2 weeks, 1 month
|
MacNab
Time Frame: Postoperative 1 months
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Patient satisfaction using the modified MacNab criteria
|
Postoperative 1 months
|
Complications
Time Frame: Intraoperative
|
Complication like nerve injury, blood, hemotoma, etc.
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Intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTK03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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