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NCT03252691 Clinical Trial

Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

Lumbar Disc Herniation Clinical Trial

— USLSI  

Official title:
Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03252691
Other study ID # USCONTROL-USLSI-001
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2020
Est. completion date May 18, 2021

Study information
Verified date May 2021
Source Intrinsic Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 18, 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Must be 18-75 years of age, and skeletally mature 2. Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1. 3. Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care. 4. Subject must understand and sign the written Informed Consent. Exclusion Criteria: 1. Prior surgery at the index lumbar vertebral level. 2. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain 3. Morbid obesity (BMI = 40 kg/m2) 4. Investigational drug or device use within 30 days

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Laser Spine Institute Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Intrinsic Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of large defects noted on primary lumbar discectomy procedure. Annular defect size will be measured intra-operatively. Intra-operatively
Secondary Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure. Amount of nucleus removed will be measured intra-operatively. Intra-operatively
Secondary Verify access to annular defect with approved manual surgical instruments. Access to the annular defect will be evaluated intra-operatively. Intra-operatively
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