NCT05487690

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	3D printing guide plate	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.
OTHER	Conventional guidance	The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.

Timeline

• Start date: 2022-10-20
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2022-08-04
• Last updated: 2022-11-01

Locations

1 site across 1 country: China