NCT03359564

Brief Summary

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

November 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

November 26, 2017

Last Update Submit

November 30, 2017

Conditions

Lumbar Disc Herniation

Keywords

Lumbar Disc HerniationMicro Endoscopic Discectomy

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index

    The efficacy of surgery were evaluated by using Oswestry Disability Index.

    2 years after operation

Secondary Outcomes (2)

  • Oswestry Disability Index

    preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation

  • Visual Analog Scale

    preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up

Study Arms (1)

micro endoscopic discectomy

the patients with lumbar disc herniation

Procedure: micro endoscopic discectomy

Interventions

micro endoscopic discectomyPROCEDURE

the patients receive micro endoscopic discectomy surgery therapy

micro endoscopic discectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent surgery for herniated disc using the tubular retractor

You may qualify if:

  • Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain
  • Patients are diagnosed with lumbar disc herniation by MRI
  • Patients who underwent surgery for herniated disc using the tubular retractor

You may not qualify if:

  • Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

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

Study Officials

  • GUO chen, bachelor

    department of spinal surgery,PekingUPH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YU Guanjie, bachelor

CONTACT

18500234005yuguanjieok@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of spinal surgery

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 2, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 2, 2017

Record last verified: 2017-11