A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions

Running, not enrolling · Not applicable

Conditions studied: Multi-Level Degenerative Lumbosacral Spinal Conditions

In brief

The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.

Key facts

Study ID

NCT03118505

Run by

Medtronic Spinal and Biologics

People needed

100

Starts

2017-06-29

Expected to finish

2026-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Degenerative lumbar spine condition:
• Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1; and
• Diagnosed with: instability (up to and including Grade 2 spondylolisthesis, retrolisthesis, or lateral listhesis), stenosis with documented pre-operative instability, and/or recurrent disc herniation, any of which may have possible concomitant lumbar degenerative deformity (Cobb angle ≤ 30 degrees).
• Preoperative ODI score ≥40.
• Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
• Most inferior treated spinal level is able to accommodate an interbody fusion device.
• ≥21 years of age at the time of signing the informed consent.
• Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
• Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.

You may not qualify if…

• Prior spinal fusion surgical procedure at the involved or adjacent spinal levels. (Prior non-fusion surgery at the target levels, including discectomy and/or single-level foraminotomy or laminectomy, is allowed.)
• Prior lumbar disc arthroplasty.
• Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level.
• Planned use of an internal or external bone growth stimulator.
• Lumbar scoliosis >30 degrees.
• Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture.
• Morbidly obese, as defined by a Body Mass Index (BMI) >40.
• Presence of active malignancy or prior history of malignancy.
• Overt or active bacterial infection, either local or systemic.
• Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
• Comorbidities precluding subject from being a surgical candidate.
• History of autoimmune disease known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
• History of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
• History of exposure to any recombinant proteins used for bone formation (i.e., Infuse Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
• Hypersensitivity or allergy to any components of the study treatments including, but not limited to, bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; gentamicin or glycerol (which may be present in trace amounts in the DBM products); and/or instrumentation materials (titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone [PEEK]).
• History of any allergy resulting in anaphylaxis.
• Is a prisoner.
• Is mentally incompetent. If questionable, obtain psychiatric consult.
• Treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
• Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for one year following surgery.
• Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk.

Where it is running

• University of California, Davis — Sacramento, California, United States
• Spine Colorado — Durango, Colorado, United States
• The Steadman Clinic — Vail, Colorado, United States
• The Spine Health Institute — Altamonte Springs, Florida, United States
• Foundation for Orthopedic Research and Education — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Fort Wayne Orthopedics — Fort Wayne, Indiana, United States
• The University of Kansas (KUMC) — Kansas City, Kansas, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• Upstate Orthopedics — East Syracuse, New York, United States
• New York-Presbyterian Hospital/Columbia University — New York, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Seton Spine & Scoliosis Center — Austin, Texas, United States
• American Neurospine Institute PLLC — Plano, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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