An interventional study of 3D printing guide plate and Conventional guidance in Lumbar Disc Herniation, Lumbar Spinal Stenosis and Radiculopathy, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
489 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 353 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Peking University Third Hospital is the lead sponsor of 745 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
3D-printed customized guide plate will be used to guide the puncture in the spinal minimally invasive and interventional surgeries.
Other: 3D printing guide plate
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
Other: Conventional guidance
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.
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
C-arm fluoroscopy times
Numbers of using C-arm fluoroscopy
Time frame: Intraoperative
Puncture time
Time from the first puncture to the last puncture
Time frame: Intraoperative
Numerical rating scale (NRS)
NRS at 1 day, 2 weeks, 1 month after the operation
Time frame: Postoperative 1 day, 2 weeks, 1 month
MacNab
Patient satisfaction using the modified MacNab criteria
Time frame: Postoperative 1 months
Complications
Complication like nerve injury, blood, hemotoma, etc.
Time frame: Intraoperative
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Displacement →
Peking University Third Hospital →