Clinical trial NCT05487690: Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
Official title: Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old,
2. Pain lasting ≥12 weeks,
3. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
4. Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
5. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
6. Agree with spinal minimally invasive and interventional surgery treatments, including endoscopic spinal surgery, radiofrequency treatment of the medial branch of the dorsal ramus or nerve root or sensory ganglion or joint, disc coblation nucleoplasty, etc.

Exclusion Criteria:

1. Patient refusal to participate in the study,
2. Pregnant or nursing
3. Allergies to local anesthetics, contrast dyes or steroids
4. Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
6. Steroid injection within the previous 12 weeks,
7. Systemic infection,
8. Injection site infection,
9. Unstable medical or psychiatric condition

Primary outcomes:
measure: C-arm fluoroscopy times
timeFrame: Intraoperative
Secondary outcomes:
measure: Puncture time
timeFrame: Intraoperative
measure: Numerical rating scale (NRS)
timeFrame: Postoperative 1 day, 2 weeks, 1 month
measure: MacNab
timeFrame: Postoperative 1 months
measure: Complications
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pain medicine center of Peking University Third Hospital
state: Beijing
Study officials:
References: