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

NCT03884283 | Completed FDA Device

• 1 other identifier: CD0001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 9

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis Lumbar

Outcome Measures

Primary Outcomes (1)

• Spinal fusion

  Spinal fusion will be determined via radiographic imaging at 12 months.

  12 months

Interventions

FIBERGRAFT BG Matrix DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Spinal tumors.
• Active arachnoiditis.
• Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• Impaired calcium metabolism.
• Active systemic infection or surgical site infection.

Sponsors & Collaborators

• Prosidyan, Inc.: lead

Study Sites (9)

Long Beach Medical Center

Long Beach, California, 90806, United States

Location

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

Palm Beach Neurosurgery

Wellington, Florida, 33449, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Washington Spine & Scoliosis Institute at OrthoBethesda

Bethesda, Maryland, 20817, United States

Location

Northwell Health Orthopaedic Institute

Great Neck, New York, 11021, United States

Location

KeiperSpine, PC

Eugene, Oregon, 97401, United States

Location

Orthopedic and Neurologic Research Institute

Fort Worth, Texas, 76132, United States

Location

University of Virginia Orthopaedics

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: February 19, 2019
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

US (9)