Study of Lumbar Discectomy With Annular Closure

September 27, 2023 updated by: Intrinsic Therapeutics

Prospective Evaluation Of Lumbar Discectomy With Additional Implantation Of An Annular Closure Device In Patients With Large Postsurgical Annular Defects For Prevention Of Lumbar Disc Reherniation

The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.

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 single-arm case series will enroll 75 patients at select US (approximately 8-10) sites. Patients that are scheduled for a single-level L4-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients that meet all intraoperative criteria will be enrolled into the study and treated with lumbar discectomy and additional annular closure device implantation. All enrolled subjects 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.
Interventional

Enrollment (Actual)

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.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • California
      • San Diego, California, United States, 92037
        • UC San Diego Health System
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist - Lyerly Neurosurgery
    • Illinois
      • Evanston, Illinois, United States, 60201
        • North Shore University Health System
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana Spine Group
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Orthopaedic Institute of Western Kentucky
    • Louisiana
      • Shreveport, Louisiana, United States, 71101-4643
        • Louisiana Spine Institute
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake Orthopaedic Clinic

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 75 years old and skeletally mature (male or female)
  2. Subjects with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. [Note: Intraoperatively, only patients with an anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
  3. At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.;
  4. Minimum posterior disc height of 5mm at the index level.
  5. Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)
  6. Oswestry Questionnaire score of at least 40/100 at baseline.
  7. VAS leg pain (one or both legs) of at least 40/100 at baseline.
  8. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

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 DEXA (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 equina 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, defined as a subject 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 a known allergy to titanium, polyethylene or polyester materials.
  19. Any subject that cannot have a baseline MRI taken.
  20. Subject is pregnant or interested in becoming pregnant in the next 2 years.
  21. Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  22. Subject has a history of active malignancy: A subject 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.
  23. Subject is immunologically suppressed, received steroids >1 month over the past year.
  24. Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
  25. Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
  26. Subject has a life expectancy of less than three (3) years.
  27. Subject is currently involved in active spinal litigation.
  28. Subject is currently involved in another investigational study.
  29. Subject is incarcerated.
  30. Any contraindication for MRI (e.g. claustrophobia, contrast allergy).

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: Annular closure device
Single arm study; all patients treated with an annular closure device
Device: Annular closure device
Annular closure, following limited discectomy procedure at a single LS level between L4 and S1

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
Blood loss
Time Frame: Intra-operative
Amount of blood loss measured in ml
Intra-operative
Procedure time
Time Frame: Intra-operative
Length of surgery, measured in minutes
Intra-operative
Hospital stay
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Length of the hospital stay measured in days between hospital admission and hospital discharge
Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Discharge status
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Evaluation of improvement in motor and sensory neurologic status
Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Leg pain severity (0-100 VAS score)
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Baseline, 4 Weeks, 3 Months, 1 year
Back pain severity (0-100 VAS score)
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Baseline, 4 Weeks, 3 Months, 1 year
ODI
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in Oswestry Disability Index. The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability
Baseline, 4 Weeks, 3 Months, 1 year
EQ-5D
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in EQ-5D. The EuroQol (EQ-5D) is a generic utility measure used to characterize current health states. The subject-reported questionnaire consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which can take one of three responses. Possible responses include three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
Baseline, 4 Weeks, 3 Months, 1 year
Satisfaction with surgery procedure
Time Frame: 1 year
Patient satisfaction with surgery and treatment assessed utilizing questionnaire with Composite questionnaire with 2 questions will be administered; 1.) Indicate degree of satisfaction with the outcome and 2.) likelihood of recommending the procedure to others
1 year
Neurological assessment
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in sensory (sensation response at dermatomal levels) reflex, (knee jerk, ankle jerk, response measured as "normal", "increased", "absent" and "decreased") and muscle strength measured 0-5 with "0" representing no evidence of motor strength and "5" representing full resistance
Baseline, 4 Weeks, 3 Months, 1 year
Adverse events
Time Frame: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure
Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Hospital readmission occurrence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of re-admissions to hospital, post treatment
Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Symptomatic reherniation incidence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of post-operative recurrent herniation at the index level. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review
Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Reoperation incidence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of post-operative reoperation at the index level
Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Return to work assessment
Time Frame: 4 Weeks, 3 Months, 1 year
Change from baseline in work status (ability to return to work, with or without reported restrictions)
4 Weeks, 3 Months, 1 year
Opioid consumption
Time Frame: Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).
Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
May 1, 2020

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.
June 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.
December 1, 2024

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 6, 2019

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 12, 2019

First Posted (Actual)

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 14, 2019

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.
  • CP-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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