Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Low Back Pain Clinical Trial

Official title:

Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632835
• Other study ID #: TTK04
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Application of 3D printing guide plate in endoscopic spinal surgery

Description:

This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal 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 or evoked pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• 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 endoscopic spinal surgeries.

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 target as evidenced by computed tomography/magnetic resonance imaging;

5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;

6. Systemic infection;

7. Injection site infection;

8. Unstable medical or psychiatric condition;

9. Unable to tolerate the surgeries.

Related Conditions & MeSH terms

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

Intervention

Other:
• 3D printing guide plate
3D-printed customized guide plate will be used to guide the puncture in endoscopic spinal surgeries to help to reduce intra-operative radiation, puncture time, etc..
• 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	Numerical rating scale (NRS) at 1 day, 2 weeks, 1 month after the operation, with 0-10 numbers and 10 represents most worse condition	Postoperative 1 day, 2 weeks, 1 month
Secondary	Patient satisfaction	Patient satisfaction using the modified MacNab criteria (MacNab)	Postoperative 1 months
Secondary	Rate of Complications	Rate of Complications like nerve injury, blood, hemotoma, etc.	Intraoperative