Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Application of 3D printing guide plate in endoscopic spinal surgery

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Lumbar Disc Herniation; Lumbar Spinal Stenosis; Radicular Pain
• Intervention / Treatment: Other: Conventional guidance; Other: 3D printing guide plate

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Pain medicine center of Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional guidance group; The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.	Other: Conventional guidance; The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT.
Experimental: 3D printing guide plate group; 3D-printed customized guide plate will be used to guide the puncture in endoscopic spinal surgeries.	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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-arm fluoroscopy times	Numbers of using C-arm fluoroscopy	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture time	Time from the first puncture to the last puncture	Intraoperative
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
Patient satisfaction	Patient satisfaction using the modified MacNab criteria (MacNab)	Postoperative 1 months
Rate of Complications	Rate of Complications like nerve injury, blood, hemotoma, etc.	Intraoperative

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopic spinal surgeries; 3D printing guide plate
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: TTK04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No