CClinicalTrials.gg
Status unknownNCT03403244Updated Apr 4, 2018

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

An interventional study of US-MR image fusion-guided PTED and fluoroscopy-guided PTED in Lumbar Herniated Disc, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Lumbar Herniated Disc
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: US-MR image fusion-guided PTED

  • Active comparator
    fluoroscopy-guided PTED

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

    Procedure: fluoroscopy-guided PTED

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

05

What researchers measure

Primary outcomes

  1. radiation exposure

    dose of radiation exposure

    Time frame: during operation

Secondary outcomes

  1. puncture accuracy

    the accuracy of puncture position confirmed by fluoroscopy.

    Time frame: during operation

  2. puncture satisfaction of surgeon

    use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more satisfactory) to evaluate the satisfaction of surgeon during puncture

    Time frame: during operation

  3. comfort of patient

    use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more comfortable) to evaluate the comfort of patient during puncture

    Time frame: during operation

  4. degree of pain

    Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)

    Time frame: preoperation, immediately postoperation, 1 week postoperation

  5. degree of disability

    Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain)

    Time frame: preoperation, immediately postoperation, 1 week postoperation

  6. puncture time

    the time from the begin of puncture to the confirmation of optimal puncture

    Time frame: during operation

06

Study locations

1 of 1 sites recruiting
  • the Third Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong 510630, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 32217792 ↗
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Registry details

Key details

Study ID
NCT03403244
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Responsible party
Limin Rong (proffesor, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Jan 18, 2018
Start date
Jan 1, 2018
Primary completion
Jan 1, 2019 (estimated)
Completion
Jan 1, 2020 (estimated)
Last update
Apr 4, 2018

Study contacts

Limin Rong, MD
Contact
ronglimin@21cn.com
+862085252900
Zihao Chen, MD
Contact
chenzihao89@163.com
+8615013228407

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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