NCT03403244

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

January 4, 2018

Last Update Submit

April 2, 2018

Conditions

Lumbar Herniated Disc

Outcome Measures

Primary Outcomes (1)

  • radiation exposure

    dose of radiation exposure

    during operation

Secondary Outcomes (6)

  • puncture accuracy

    during operation

  • puncture satisfaction of surgeon

    during operation

  • comfort of patient

    during operation

  • degree of pain

    preoperation, immediately postoperation, 1 week postoperation

  • degree of disability

    preoperation, immediately postoperation, 1 week postoperation

  • +1 more secondary outcomes

Study Arms (2)

US-MR image fusion-guided PTED

EXPERIMENTAL

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

fluoroscopy-guided PTED

ACTIVE COMPARATOR

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

Procedure: fluoroscopy-guided PTED

Interventions

US-MR image fusion-guided PTEDPROCEDURE

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

US-MR image fusion-guided PTED
fluoroscopy-guided PTEDPROCEDURE

patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED

fluoroscopy-guided PTED

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • persistent radicular pain.
  • an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient
  • single responsible segment of lumbar disc herniation
  • L4-5 segment

You may not qualify if:

  • Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
  • Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
  • Equal to or more than two responsible level
  • Previous spinal surgery
  • unable to collaborate during surgery
  • far-lateral disc herniation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32217792DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Limin Rong, MD

CONTACT

+862085252900ronglimin@21cn.com

Zihao Chen, MD

CONTACT

+8615013228407chenzihao89@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
proffesor

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 18, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

CN(1)