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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884283
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Prosidyan, Inc.

Brief Summary:
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Spinal Stenosis Lumbar Device: FIBERGRAFT BG Matrix Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: FIBERGRAFT BG Matrix
    Subjects who meet the criteria for entrance into the study will undergo posterolateral fusion using FIBERGRAFT® BG Matrix in combination with local bone autograft and bone marrow aspirate (BMA)


Primary Outcome Measures :
  1. Spinal fusion [ Time Frame: 12 months ]
    Spinal fusion will be determined via radiographic imaging at 12 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884283


Locations
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United States, Kentucky
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42001
Sponsors and Collaborators
Prosidyan, Inc.

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Responsible Party: Prosidyan, Inc.
ClinicalTrials.gov Identifier: NCT03884283     History of Changes
Other Study ID Numbers: CD0001
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis