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

NCT05487690 | Unknown

• 1 other identifier: TTK02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• C-arm fluoroscopy times

  Numbers of using C-arm fluoroscopy

  Intraoperative

Secondary Outcomes (4)

• Puncture time

  Intraoperative

• Numerical rating scale (NRS)

  Postoperative 1 day, 2 weeks, 1 month

• MacNab

  Postoperative 1 months

• Complications

  Intraoperative

Study Arms (2)

3D printing guide plate group

EXPERIMENTAL

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

Conventional guidance group

ACTIVE COMPARATOR

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

Other: Conventional guidance

Interventions

3D printing guide plate OTHER

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.

3D printing guide plate group

Conventional guidance OTHER

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

Conventional guidance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old,
• Pain lasting ≥12 weeks,
• The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
• Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
• Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Pain medicine center of Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Spinal Stenosis; Radiculopathy; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Shuiqing Li

CONTACT

+86 01082265690; bjfdfx@126.com

Qipeng Luo

CONTACT

+86 01082265026; 1293194276@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: October 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)