Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03252691

Acronym

USLSI

Enrollment

Registered

2017-08-17

Start date

2020-09-30

Completion date

2021-05-18

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results