NCT05403775

Application of 3D Printing Guide Plate in Dorsal Root Ganglion Intervention Treatments

Application of 3D Printing Guide Plate in Transforaminal Epidural Steroid Injection (TFESI) Combined With Pulsed Radiofrequency (PRF) Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study applies 3D-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (TFESI) combined with pulsed radiofrequency (PRF) treatment. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

Detailed description

Lumbar disc herniation (LDH) is a common degenerative spine disease and it can cause low back pain and lumbosacral radicular pain (LSRP). Transforaminal epidural steroid injection (TFESI) is one of the most common minimally invasive interventions for the treatment of LDH. TFESI combined with dorsal root ganglion pulsed radiofrequency (PRF) is an effective procedure for treating LSRP. Needle Puncture is the key technology in this procedure. 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 is well solved by applying the 3D printing guide plate. The application procedure for the the 3D printing guide plate: the model of the spine 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

Interventions

Type	Name	Description
OTHER	3D printing guide plate	3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF 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.

Timeline

• Start date: 2022-07-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-06-03
• Last updated: 2022-08-03

Locations

1 site across 1 country: China