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

US-MR Image Fusion-guided Versus Fluoroscopy-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation: a Comparative Cohort Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03403244
Enrollment
20
Registered
2018-01-18
Start date
2018-01-01
Completion date
2020-01-01
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Herniated Disc

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.

Interventions

PROCEDUREUS-MR image fusion-guided PTED

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

PROCEDUREfluoroscopy-guided PTED

patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
radiation exposureduring operationdose of radiation exposure

Secondary

MeasureTime frameDescription
puncture satisfaction of surgeonduring operationuse Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more satisfactory) to evaluate the satisfaction of surgeon during puncture
comfort of patientduring operationuse Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more comfortable) to evaluate the comfort of patient during puncture
puncture accuracyduring operationthe accuracy of puncture position confirmed by fluoroscopy.
degree of disabilitypreoperation, immediately postoperation, 1 week postoperationOswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain)
puncture timeduring operationthe time from the begin of puncture to the confirmation of optimal puncture
degree of painpreoperation, immediately postoperation, 1 week postoperationVisual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)

Countries

China

Contacts

Primary ContactLimin Rong, MD
ronglimin@21cn.com+862085252900
Backup ContactZihao Chen, MD
chenzihao89@163.com+8615013228407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026