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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Lumbar Disc Herniation; Radiculopathy; Lumbar Spinal Stenosis; Radicular Pain; 3D Printing Guide Plate; Lumbosacral Facet Joint Syndrome; Ischemic Pain of the Lower Extremity; Spinal Minimally Invasive and Interventional Surgeries
• 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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuiqing Li; Phone Number: +86 01082265690; Email: bjfdfx@126.com
• Study Contact Backup: Name: Qipeng Luo; Phone Number: +86 01082265026; Email: 1293194276@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Pain medicine center of Peking University Third Hospital
      • Contact: Shuiqing Li, MD; Phone Number: 01082266699; Email: bjfdfx@126.com
      • Contact: Qipeng Luo, MD; Phone Number: 01082265026; Email: 1293194276@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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 the spinal minimally invasive and interventional surgeries.	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.

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 (NRS)	NRS at 1 day, 2 weeks, 1 month after the operation	Postoperative 1 day, 2 weeks, 1 month
MacNab	Patient satisfaction using the modified MacNab criteria	Postoperative 1 months
Complications	Complication like nerve injury, blood, hemotoma, etc.	Intraoperative

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Radiculopathy; Spinal Stenosis
• Other Study ID Numbers: TTK02

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