US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation

NCT ID: NCT03403244

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-01

Brief Summary

The purpose of this study is to evaluate the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation

Detailed Description

Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) a widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. However, the use of fluoroscopy may be usually required to indirectly visualize pertinent anatomy to achieve an optimal result on radiographs. As we known, increased radiation exposure may be associated with potential stochastic and deterministic adverse events. Therefore, it is important to reduce the radiation dose of practitioners to minimize risk of potential radiation-induced complications.

Ultrasound-MR fusion technique combines the advantages of ultrasound and MR, and overcome the shortcomings of each single imaging method. It provides MR cross-sectional multiplanar images that correspond to the acquired real-time US images, and all images can be displayed simultaneously and in real time according to the angle of the US transducer. US-MR fusion image has been widely used in prostate and liver intervention. However, to our limited knowledge, there is only one research about the application of US-MR fusion image in lumbar spinal surgery.

In this study, a comparative cohort study will be performed to evaluate feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation(LDH). We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.

Two groups of patients will be investigated: patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED (US-MR PTED), and fluoroscopy-guided PTED (FL PTED).

The primary outcomes of the study will be radiation exposure and puncture time. Secondary outcomes include fusion efficacy, puncture accuracy, puncture satisfaction of surgeon, comfort of patient and clinical effectiveness.

On the basis of the results of this trial we will, for the first time, have scientific evidence as to the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation.

Conditions

Lumbar Herniated Disc

Study Design

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

Study Groups

US-MR image fusion-guided PTED

US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique.

Group Type: EXPERIMENTAL

US-MR image fusion-guided PTED

Intervention Type: PROCEDURE

patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED

fluoroscopy-guided PTED

fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy.

Group Type: ACTIVE_COMPARATOR

fluoroscopy-guided PTED

Intervention Type: PROCEDURE

patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED

Interventions

US-MR image fusion-guided PTED

patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED

Intervention Type: PROCEDURE

fluoroscopy-guided PTED

patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. persistent radicular pain.

2. an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient

3. single responsible segment of lumbar disc herniation

4. L4-5 segment

Exclusion Criteria

1. Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention

2. Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)

3. Equal to or more than two responsible level

4. Previous spinal surgery

5. unable to collaborate during surgery

6. far-lateral disc herniation

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Limin Rong

proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Limin Rong, MD

Role: CONTACT

ronglimin@21cn.com

+862085252900

Zihao Chen, MD

Role: CONTACT

chenzihao89@163.com

+8615013228407

Facility Contacts

Limin Rong, M.D.

Role: primary

ronglimin@21cn.com

862085252900

References

Xie P, Feng F, Cao J, Chen Z, He B, Kang Z, He L, Wu W, Tan L, Li K, Zheng R, Rong L. Real-time ultrasonography-magnetic resonance image fusion navigation for percutaneous transforaminal endoscopic discectomy. J Neurosurg Spine. 2020 Mar 27;33(2):192-198. doi: 10.3171/2020.1.SPINE191223. Print 2020 Aug 1.

Reference Type: DERIVED

PMID: 32217792 (View on PubMed)

Other Identifiers

US-MR guided PTED for LDH

Identifier Type: -

Identifier Source: org_study_id