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Application of 3D printing guide plate in endoscopic spinal surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printing guide plate group | Experimental | 3D-printed customized guide plate will be used to guide the puncture in endoscopic spinal surgeries. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printing guide plate | Other | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| C-arm fluoroscopy times | Numbers of using C-arm fluoroscopy | Intraoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain medicine center of Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D013130 | Spinal Stenosis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Conventional guidance | Other | The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. |
|
| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |