Status:
WITHDRAWN
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Lead Sponsor:
Intrinsic Therapeutics
Conditions:
Lumbar Disc Herniation
Anular Tear of Lumbar Disc
Eligibility:
All Genders
18-75 years
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.
Eligibility Criteria
Inclusion
- Must be 18-75 years of age, and skeletally mature
- Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
- Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
- Subject must understand and sign the written Informed Consent.
Exclusion
- Prior surgery at the index lumbar vertebral level.
- Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
- Morbid obesity (BMI ≥ 40 kg/m2)
- Investigational drug or device use within 30 days
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03252691
Start Date
September 1 2020
End Date
May 18 2021
Last Update
May 20 2021
Active Locations (1)
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1
Laser Spine Institute
Tampa, Florida, United States, 33607