Microendoscopic Lumbar Discectomy: A Study of 100 Cases

November 30, 2017 updated by: guochen, Peking University People's Hospital

Microendoscopic Lumbar Discectomy: A Prospective Study of 100 Cases

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgery for herniated disc using the tubular retractor

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
micro endoscopic discectomy
the patients with lumbar disc herniation
Procedure: micro endoscopic discectomy
the patients receive micro endoscopic discectomy surgery therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 2 years after operation
The efficacy of surgery were evaluated by using Oswestry Disability Index.
2 years after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation
The efficacy of surgery were evaluated by using Oswestry Disability Index.
preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation
Visual Analog Scale
Time Frame: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up
The efficacy of surgery were evaluated by using Visual Analog Scale for back and leg pain.
preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: GUO chen, bachelor, department of spinal surgery,PekingUPH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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