Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printing guide plate group | Experimental | 3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional 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 the spinal minimally invasive and interventional surgeries. to help to reduce intra-operative radiation. |
| 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 (NRS) | NRS at 1 day, 2 weeks, 1 month after the operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuiqing Li | Contact | +86 01082265690 | bjfdfx@126.com | |
| Qipeng Luo | Contact | +86 01082265026 | 1293194276@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain medicine center of Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| MacNab | Patient satisfaction using the modified MacNab criteria | Postoperative 1 months |
| Complications | Complication like nerve injury, blood, hemotoma, etc. | Intraoperative |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D013130 | Spinal Stenosis |
| D011843 | Radiculopathy |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided