Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT

April 18, 2024 updated by: Prosidyan, Inc.

A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix

This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
102

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
      • Long Beach, California, United States, 90806
        • Memorial Orthopaedic Surgical Group
      • Long Beach, California, United States, 90806
        • Long Beach Medical Center
    • Florida
      • Wellington, Florida, United States, 33449
        • Palm Beach Neurosurgery
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Orthopaedic Institute of Western Kentucky
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Washington Spine & Scoliosis Institute at OrthoBethesda
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health Orthopaedic Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • KeiperSpine, PC
    • Texas
      • Fort Worth, Texas, United States, 76132
        • Orthopedic and Neurologic Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Orthopaedics

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Is at least 18 years of age and skeletally mature.
  3. Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1, requiring a fusion.
  4. Must have completed a minimum of three months of unsuccessful conservative, non-operative care.
  5. DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans.
  6. Must score at least 40 points on the Oswestry Disability Index.
  7. Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain.
  8. Must be able to comply with the protocol's follow-up schedule.
  9. Must understand and sign the IRB approved informed consent document.

Exclusion Criteria:

  1. Symptomatic at more than two levels.
  2. Previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the index level (> 6 months) is permitted).
  3. Previous total disc replacement at any lumbar level.
  4. Undergoing fusion for recurrent stenosis at the level to be treated.
  5. Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology.
  6. Spondylolisthesis not able to be reduced to grade I.
  7. Lumbar scoliosis greater than 11 degrees.
  8. Osteoporosis*, osteopenia, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing.
  9. Use of posterior instrumentation for stabilization is not possible.
  10. Intra-operative soft tissue coverage is not possible.
  11. Spinal tumors.
  12. Active arachnoiditis.
  13. Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
  14. Impaired calcium metabolism.
  15. Active systemic infection or surgical site infection.
  16. Osteomyelitis at the graft site.
  17. Rheumatoid arthritis or other autoimmune disease.
  18. Chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
  19. Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
  20. Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight.
  21. Smokers unless the subject agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
  22. Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse.
  23. Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
  24. Documented allergies to titanium.
  25. Subjects with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because FIBERGRAFT® BG Matrix contains bovine collagen.
  26. Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years.
  27. Participation in another investigational study within 30 days.
  28. Prisoners.

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

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
Spinal fusion
Time Frame: 12 months
Spinal fusion will be determined via radiographic imaging at 12 months.
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.
Prosidyan, Inc.

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 19, 2019

Primary Completion (Actual)

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.
May 21, 2023

Study Completion (Actual)

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.
May 21, 2023

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).
March 19, 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.
March 19, 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.
March 21, 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.
April 22, 2024

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.
April 18, 2024

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.
April 1, 2024

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.
  • CD0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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