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

Prosidyan, Inc.9 sites in 1 country102 target enrollmentFebruary 19, 2019

ConditionsDegenerative Disc Disease Spondylolisthesis Spinal Stenosis Lumbar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Prosidyan, Inc.
Enrollment: 102
Locations: 9
Primary Endpoint: Spinal fusion
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 19, 2019

End Date

May 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Prosidyan, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

•Symptomatic at more than two levels.
•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).
•Previous total disc replacement at any lumbar level.
•Undergoing fusion for recurrent stenosis at the level to be treated.
•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 11 degrees.
•Osteoporosis\*, osteopenia, 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.