Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

NCT03252691 | Withdrawn DMC

• 1 other identifier: USCONTROL-USLSI-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of large defects noted on primary lumbar discectomy procedure.

  Annular defect size will be measured intra-operatively.

  Intra-operatively

Secondary Outcomes (2)

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

  Intra-operatively

• Verify access to annular defect with approved manual surgical instruments.

  Intra-operatively

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intrinsic Therapeutics: lead

Study Sites (1)

Laser Spine Institute

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Reginald Davis, MD

  Laser Spine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 18, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

US (1)