Application of 3D Printing Guide Plate in Percutaneous Disc Decompression

NCT05610553 | Unknown

• 1 other identifier: TTK03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Application of 3D printing guide plate in percutaneous disc decompression

Conditions

Lumbar Disc Herniation; Radiculopathy; Percutaneous Disc Decompression; 3D Printing Guide Plate; Radicular Pain; Low Back Pain; Discogenic 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 percutaneous disc decompression 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 percutaneous disc decompression surgeries to help to reduce intra-operative radiation, puncture time, etc..

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 percutaneous disc decompression.

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 target as evidenced by computed tomography/magnetic resonance imaging;
• Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;
• Systemic infection;
• Injection site infection;
• Unstable medical or psychiatric condition;
• Unable to tolerate the surgeries.

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; 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

Study Design

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

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 9, 2022
• Study Start: December 10, 2022
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)