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

NCT03118505 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P16-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Multi-Level Degenerative Lumbosacral Spinal Conditions

Outcome Measures

Primary Outcomes (1)

• Radiological Fusion Success

  Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level: * Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT); * No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and * Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass (all radiograph views).

  12 months

Secondary Outcomes (11)

• Overall success rate at 12 and 24 months

  12 and 24 months

• ODI score at 12 and 24 months

  12 and 24 months

• ODI success rate at 12 and 24 months

  12 and 24 months

• Neurological success rate at 12 and 24 months

  12 and 24 months

• Back pain score at 12 and 24 months

  12 and 24 months

Study Arms (4)

Group 1

EXPERIMENTAL

Infuse Bone Graft \[4.2 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Device: Infuse Bone Graft

Group 2

EXPERIMENTAL

Infuse Bone Graft \[6 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Device: Infuse Bone Graft

Group 3

EXPERIMENTAL

Infuse Bone Graft \[12 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Device: Infuse Bone Graft

Control

ACTIVE COMPARATOR

Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.

Device: Medtronic DBM

Interventions

Infuse Bone Graft DEVICE

Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation

Group 1; Group 2; Group 3

Medtronic DBM DEVICE

Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[PEEK\]).

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (17)

University of California, Davis

Sacramento, California, 95816, United States

Location

Spine Colorado

Durango, Colorado, 81301, United States

Location

The Steadman Clinic

Vail, Colorado, 81657, United States

Location

The Spine Health Institute

Altamonte Springs, Florida, 32701, United States

Location

Foundation for Orthopedic Research and Education

Tampa, Florida, 33637, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Fort Wayne Orthopedics

Fort Wayne, Indiana, 46804, United States

Location

The University of Kansas (KUMC)

Kansas City, Kansas, 66160, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

New York-Presbyterian Hospital/Columbia University

New York, New York, 10034, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Seton Spine & Scoliosis Center

Austin, Texas, 78731, United States

Location

American Neurospine Institute PLLC

Plano, Texas, 75075, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Officials

• Chetan Patel

  Spine Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: June 29, 2017
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (17)