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

Intrinsic Therapeutics

Status: Withdrawn

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03252691

USCONTROL-USLSI-001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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