Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries

Study Overview
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Brief Summary
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Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries

Detailed Description
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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.

Official Title
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Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries

Conditions
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Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy, Lumbosacral Facet Joint Syndrome, Ischemic Pain of the Lower Extremity, Spinal Minimally Invasive and Interventional Surgeries, 3D Printing Guide Plate, Radicular Pain, Low Back Pain

Intervention / Treatment
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* Other: 3D printing guide plate
* Other: Conventional guidance


Participation Criteria
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Eligibility Criteria
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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 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. 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 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, Systemic infection, Injection site infection, Unstable medical or psychiatric condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printing guide plate group<br>3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries. | Other: 3D printing guide plate<br>* 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.<br>|
| Active Comparator: Conventional guidance group<br>The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. | Other: Conventional guidance<br>* The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-arm fluoroscopy times | Numbers of using C-arm fluoroscopy | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture time | Time from the first puncture to the last puncture | Intraoperative | 
| Numerical rating scale (NRS) | NRS at 1 day, 2 weeks, 1 month after the operation | Postoperative 1 day, 2 weeks, 1 month | 
| MacNab | Patient satisfaction using the modified MacNab criteria | Postoperative 1 months | 
| Complications | Complication like nerve injury, blood, hemotoma, etc. | Intraoperative |