Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

Intrinsic Therapeutics

Overview

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

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

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Laser Spine Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Incidence of large defects noted on primary lumbar discectomy procedure.

Annular defect size will be measured intra-operatively.

Time frame: Intra-operatively

Secondary Outcomes

Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.

Amount of nucleus removed will be measured intra-operatively.

Time frame: Intra-operatively

Verify access to annular defect with approved manual surgical instruments.

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

Time frame: Intra-operatively

Data from ClinicalTrials.gov

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