Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Study Overview
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Brief Summary
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Application of 3D printing guide plate in endoscopic spinal surgery

Detailed Description
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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.

Official Title
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Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Conditions
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Radicular Pain, Lumbar Disc Herniation, Lumbar Spinal Stenosis, 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 endoscopic spinal surgeries. 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.

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: Other
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 endoscopic spinal surgeries. | Other: 3D printing guide plate<br>* 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..<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 | Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition | Postoperative 1 day, 2 weeks, 1 month | 
| Patient satisfaction | Patient satisfaction using the modified MacNab criteria (MacNab) | Postoperative 1 months | 
| Rate of Complications | Rate of Complications like nerve injury, blood, hemotoma, etc. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic spinal surgeries, 3D printing guide plate