Incidence of Large Annular Defects in Primary Lumbar Disc... | NCT03252691

Studies
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

NCT03252691

Sponsor

Intrinsic Therapeutics

Status

Withdrawn

Last Update Posted

May 20, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lumbar Disc Herniation
Anular Tear of Lumbar Disc
Nucleus Pulp Hernia;Lumbosac

Interventions

Not provided

Countries

United States

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

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site closure and no patient enrolled

Expanded Access Info

Start Date

Sep 2020Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

May 18, 2021Actual

First Submitted Date

Aug 15, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 17, 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

May 18, 2021

Last Update Posted Date

May 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Lumbar discectomy study, collection and evaluation of incidence of large annular defects.

Detailed Description

This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of large defects noted on primary lumbar discectomy procedure.	Annular defect size will be measured intra-operatively.	Intra-operatively

Secondary Outcomes

Measure	Description	Time Frame
Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.	Amount of nucleus removed will be measured intra-operatively.	Intra-operatively
Verify access to annular defect with approved manual surgical instruments.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be 18-75 years of age, and skeletally mature
Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

Prior surgery at the index lumbar vertebral level.
Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
Morbid obesity (BMI ≥ 40 kg/m2)
Investigational drug or device use within 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

One hundred and fifty (150) subjects will participate in the study. Participants will be between 18 and 75 years of age. All subjects will have been diagnosed with primary lumbar disc herniation requiring surgical discectomy as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria, do not meet any of the exclusion criteria, and who elect to participate and sign the informed consent will be included in the study.

Sampling Method

Probability Sample

Name	Affiliation	Role
Reginald Davis, MD	Laser Spine Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Laser Spine Institute		Tampa	Florida	33607	United States

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