Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients (USLSI)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Disc Herniation; Anular Tear of Lumbar Disc; Nucleus Pulp Hernia;Lumbosac

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Laser Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Access to the annular defect will be evaluated intra-operatively.	Intra-operatively

Collaborators and Investigators

• Sponsor: Intrinsic Therapeutics
• Investigators: Principal Investigator: Reginald Davis, MD, Laser Spine Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: USCONTROL-USLSI-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No