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



Status:Recruiting
Healthy:No
Age Range:21 - Any
Updated:11/3/2018
Start Date:June 29, 2017
End Date:August 2020

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A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions

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.


Inclusion Criteria:

1. Degenerative lumbar spine condition:

1. Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4
consecutive levels from L2-S1; and

2. 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).

2. Preoperative ODI score ≥40.

3. Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.

4. Most inferior treated spinal level is able to accommodate an interbody fusion device.

5. ≥21 years of age at the time of signing the informed consent.

6. Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy,
medications, spinal injections, manipulation, and/or TENS).

7. Is willing and able to comply with the study plan and able to understand and sign the
Subject Informed Consent Form.

Exclusion Criteria:

1. 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.)

2. Prior lumbar disc arthroplasty.

3. 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.

4. Planned use of an internal or external bone growth stimulator.

5. Lumbar scoliosis >30 degrees.

6. Osteoporosis to a degree that spinal instrumentation is contraindicated or a history
of atraumatic vertebral fracture.

7. Morbidly obese, as defined by a Body Mass Index (BMI) >40.

8. Presence of active malignancy or prior history of malignancy.

9. Overt or active bacterial infection, either local or systemic.

10. 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.

11. Comorbidities precluding subject from being a surgical candidate.

12. History of autoimmune disease known to affect bone metabolism or the spine (e.g.,
spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease,
Hashimoto's thyroiditis).

13. History of any endocrine or metabolic disorder known to affect osteogenesis (e.g.,
Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis
imperfecta).

14. 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).

15. 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]).

16. History of any allergy resulting in anaphylaxis.

17. Is a prisoner.

18. Is mentally incompetent. If questionable, obtain psychiatric consult.

19. 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.

20. Pregnant or nursing. Females of child-bearing potential must agree not to become
pregnant for one year following surgery.

21. 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.
We found this trial at
13
sites
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Kee Kim, MD
Phone: 916-734-1652
University of California-Davis As we begin our second century, UC Davis is poised to become...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Keith Michael, MD
Phone: 404-778-6857
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Gregory Wiggins, MD
Phone: 269-720-6759
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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711 East Altamonte Drive
Altamonte Springs, Florida 32701
Principal Investigator: Chetan Patel, MD
Phone: 407-303-2367
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Austin, Texas 78731
Principal Investigator: Eeric Truumees, MD
Phone: 512-324-3580
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Carmel, Indiana 46032
Principal Investigator: Joseph Smucker, MD
Phone: 317-715-5897
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Mark E. Shaffrey, MD
Phone: 434-982-1856
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Durango, Colorado 81301
Principal Investigator: Douglas Orndorff, MD
Phone: 970-375-3696
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East Syracuse, New York 13057
Principal Investigator: William Lavelle, MD
Phone: 315-464-8618
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Fort Wayne, Indiana 46804
Principal Investigator: Kevin A Rahn, MD
Phone: 260-436-8686
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Kansas City, Kansas 66160
Principal Investigator: Paul Arnold, MD
Phone: 913-945-8190
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13020 Telecom Parkway North
Tampa, Florida 33637
Principal Investigator: John Small, MD
Phone: 813-978-9700
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Vail, Colorado 81657
Principal Investigator: Donald Corenman, MD
Phone: 970-479-1587
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