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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05487690
• Other study ID #: TTK02
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2022
• Source: Peking University Third Hospital
• Contact: Shuiqing Li
• Phone: +86 01082265690
• Email: bjfdfx[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Radicular Pain
• Radiculopathy
• Spinal Stenosis

Intervention

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.
• Conventional guidance
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.

Locations

Country	Name	City	State
China	Pain medicine center of Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-arm fluoroscopy times	Numbers of using C-arm fluoroscopy	Intraoperative
Secondary	Puncture time	Time from the first puncture to the last puncture	Intraoperative
Secondary	Numerical rating scale (NRS)	NRS at 1 day, 2 weeks, 1 month after the operation	Postoperative 1 day, 2 weeks, 1 month
Secondary	MacNab	Patient satisfaction using the modified MacNab criteria	Postoperative 1 months
Secondary	Complications	Complication like nerve injury, blood, hemotoma, etc.	Intraoperative