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

NCT ID: NCT05487690

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2025-01-31

Brief Summary

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

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3D printing guide plate

Intervention Type: 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.

Conventional guidance group

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

Group Type: ACTIVE_COMPARATOR

Conventional guidance

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Conventional guidance

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pain medicine center of Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Shuiqing Li

Role: CONTACT

bjfdfx@126.com

+86 01082265690

Qipeng Luo

Role: CONTACT

1293194276@qq.com

+86 01082265026

Facility Contacts

Shuiqing Li, MD

Role: primary

bjfdfx@126.com

01082266699

Qipeng Luo, MD

Role: backup

1293194276@qq.com

01082265026

Other Identifiers

TTK02

Identifier Type: -

Identifier Source: org_study_id