Lumbar Discectomy Control Study, Risk Factors for Reherniation

September 27, 2023 updated by: Intrinsic Therapeutics

A Prospective, Multicenter Study Investigating Reherniation Risk Factors and Associated Costs in Primary Lumbar Disc Herniation Patients

The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll up to 100 patients at select US (approximately 4-7) sites. Patients that are scheduled for an L1-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients will be divided into two arms (small- and large-defect) based on the size of their annular defect as measured intra-operatively; each arm will be capped at 50 patients. All patients included in the trial will be followed for at least 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopaedics at Rush Medical Center
    • Kansas
      • Galena, Kansas, United States, 66739
        • Orthopaedic Specialists Of The Four States
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Orthopaedic Institute of Western Kentucky
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Michigan Orthopedic Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with single level, symptomatic lumbar disc herniation

Description

Inclusion Criteria:

  1. Age 21 to 75 years old and skeletally mature (male or female).
  2. Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using MRI. [Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
  3. Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
  4. Oswestry Questionnaire score of at least 40/100 at baseline.
  5. VAS leg pain (one or both legs) of at least 40/100 at baseline.
  6. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
  7. Minimum posterior disc height of 5mm at the index level.

Exclusion Criteria:

  1. Spondylolisthesis Grade II or higher (25% slip or greater).
  2. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
  3. Subject has back or non-radicular leg pain of unknown etiology.
  4. Prior surgery at the index lumbar vertebral level.
  5. Subject requiring a spine dual energy x-ray absorptiometry (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
  6. Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
  7. Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
  8. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  9. Any metabolic bone disease.
  10. Subject has an active infection either systemic or local.
  11. Subject has cauda equine syndrome or neurogenic bowel/bladder dysfunction.
  12. Subject has severe arterial insufficiency of the legs or other peripheral vascular disease. (Screening on physical examination for patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded.)
  13. Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
  14. Subject has insulin-dependent diabetes mellitus.
  15. Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).
  16. Subject has been diagnosed with active hepatitis, AIDS, or HIV.
  17. Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  18. Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  19. Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
  20. Subject is immunologically suppressed, received steroids >1 month over the past year.
  21. Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
  22. Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
  23. Subject has a life expectancy of less than three (3) years.
  24. Subject is currently involved in active spinal litigation.
  25. Subject is currently involved in another investigational study.
  26. Subject is incarcerated.
  27. Patients will be divided into two arms (small- and large-defect) based on the width of their annular defect as measured intra-operatively. Patients with defects <6mm in width will be in the "small defect" arm; patients with defects ≥6mm in width will be in the "large defect" arm. Each arm will be capped at 50 patients. Once 50 patients are accrued in one arm, subsequent patients who meet the criteria for that arm will be excluded. Enrollment will continue until both arms are filled.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Small annular defect group
Patients with lumbar defect less than 6mm wide after lumbar discectomy
Other: Discectomy
Lumbar discectomy
Large annular defect group
Patients with lumbar defect greater than 6mm wide after lumbar discectomy
Other: Discectomy
Lumbar discectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lumbar reherniation at the index level
Time Frame: 12 Months
Reherniation of index level, yes or no
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reoperation at the index level
Time Frame: 12 Months
Reoperation at index level, yes or no
12 Months
Hospitalization at physician cost
Time Frame: 12 Months
The total hospitalization and physician costs for the index surgery and any secondary surgical intervention of the index level will be summed and reported for each subject based on data collected on the UB-04
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intrinsic Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: David H Kim, MD, New England Baptist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US CONTROL-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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