A POST-MARKET, PROSPECTIVE, MULTI-CENTER, NONRANDOMIZED STUDY TO ASSESS POSTEROLATERAL LUMBAR FUSIONS USING FIBERGRAFT® BG MATRIX

  • STATUS
    Recruiting
Updated on 11 June 2020

Summary

This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft bone and bone marrow aspirate in posterolateral fusion.

This study is designed to assess outcomes in patients with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion.

 

Details
Condition Spinal Stenosis, Spondylolisthesis, Spinal Surgery
Clinical Study IdentifierTX234366
Last Modified on11 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject can be included in the study if all of the following criteria are
met
Signed Informed Consent Form
Is at least 18 years of age and skeletally mature
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
Must have completed a minimum of three months of unsuccessful conservative, non-operative care
DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans
Must score at least 40 points on the Oswestry Disability Index
Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain
Must be able to comply with the protocol's follow-up schedule
Must understand and sign the IRB approved informed consent document

Exclusion Criteria

The subject must not exhibit any of the following criteria
Requiring fusion at more than two levels
Previous fusion surgery at any lumbar level with or without instrumentation Previous total disc replacement at any lumbar level
Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology
Spondylolisthesis not able to be reduced to grade I
Lumbar scoliosis greater than 15 degrees
Osteoporosis, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing
Use of posterior instrumentation for stabilization is not possible
Intra-operative soft tissue coverage is not possible
Spinal tumors
Active arachnoiditis
Fractures of the vertrebral body or morphology that would affect instrumentation at that level
Impaired calcium metabolism
Active systemic infection or surgical site infection
Osteomyelitis at the graft site
Rheumatoid arthritis or other autoimmune disease
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
Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight
Current smokers
Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse
Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years
Documented allergies to titanium
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
Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years
Participation in another investigational study within 30 days
Prisoners
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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