Microendoscopic Lumbar Discectomy: A Study of 100 Cases | NCT03359564

Studies
Microendoscopic Lumbar Discectomy: A Study of 100 Cases

NCT03359564

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lumbar Disc Herniation

Interventions

micro endoscopic discectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2017

Last Update Posted Date

Dec 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

guochen, department of spinal surgery, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
micro endoscopic discectomy		the patients with lumbar disc herniation	Procedure: micro endoscopic discectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
micro endoscopic discectomy	Procedure	the patients receive micro endoscopic discectomy surgery therapy	micro endoscopic discectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Oswestry Disability Index	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent surgery for herniated disc using the tubular retractor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YU Guanjie, bachelor	Contact	18500234005		yuguanjieok@163.com

Overall Officials

Name	Affiliation	Role
GUO chen, bachelor	department of spinal surgery,PekingUPH	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided