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

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ClinicalTrials.gov Identifier: NCT03118505
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

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.

Condition or disease Intervention/treatment Phase
Multi-Level Degenerative Lumbosacral Spinal Conditions Device: Infuse Bone Graft Device: Medtronic DBM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Group 1
Infuse Bone Graft [4.2 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
Device: Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation

Experimental: Group 2
Infuse Bone Graft [6 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
Device: Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation

Experimental: Group 3
Infuse Bone Graft [12 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation
Device: Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation

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




Primary Outcome Measures :
  1. Radiological Fusion Success [ Time Frame: 12 months ]

    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).


Secondary Outcome Measures :
  1. Overall success rate at 12 and 24 months [ Time Frame: 12 and 24 months ]

    Overall success is defined as the participant who meet the following five criteria:

    • Radiographic success, defined as radiological fusion success in the posterolateral space;
    • Pain/disability (ODI) success, defined as at least a 15-point improvement from baseline;
    • Neurological success, defined as maintenance or improvement in neurological status;
    • No SAE related to the PLF grafting material or posterior fixation; and
    • No secondary surgeries classified as a "failure."

  2. ODI score at 12 and 24 months [ Time Frame: 12 and 24 months ]
    The self-administered Oswestry Disability Index (ODI) Questionnaire (Version 2.1) will be used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

  3. ODI success rate at 12 and 24 months [ Time Frame: 12 and 24 months ]
    ODI success is defined as at least a 15-point improvement from baseline.

  4. Neurological success rate at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Overall neurological success is defined as maintenance or improvement in four key neurological assessments: motor function, sensory function, reflexes, and straight leg raise. In order to be considered a success, each element in the motor, sensory, reflexes, and straight leg raise examinations must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

  5. Back pain score at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Numerical rating scales, adapted in part from Measuring Health, will be used to evaluate back pain. The back pain score (0-20) is the summation of pain intensity (0-10) and duration (0-10) scores.

  6. Back pain success at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Back pain success is defined as at least 30% improvement from baseline.

  7. Leg pain score at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Numerical rating scales, adapted in part from Measuring Health, will be used to evaluate leg pain. The leg pain score (0-20) is the summation of pain intensity (0-10) and duration (0-10) scores.

  8. Leg pain success at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Leg pain success is defined as at least 30% improvement from baseline.

  9. Radiological fusion success rate at 24 months [ Time Frame: 24 months ]

    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).

  10. AEs related to the PLF grafting material or posterior fixation up to 24 months [ Time Frame: 24 months ]
    A summary of AEs related to the PLF grafting material or posterior fixation up to 24 months.

  11. Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months [ Time Frame: 24 months ]
    A summary of secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118505


Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95816
Contact: Carly Davis    916-734-1652    cjddavis@ucdavis.edu   
Principal Investigator: Kee Kim, MD         
Sub-Investigator: Jared Ament, MD         
Sub-Investigator: Julius Ebinu, MD         
United States, Colorado
Spine Colorado Recruiting
Durango, Colorado, United States, 81301
Contact: Juliana Hill    970-375-3696    jhill@spinecolorado.com   
Principal Investigator: Douglas Orndorff, MD         
Sub-Investigator: Jim Youssef, MD         
The Steadman Clinic Recruiting
Vail, Colorado, United States, 81657
Contact: Kaitie Whitney    970-479-1587    kwhitney@thesteadmanclinic.com   
Principal Investigator: Donald Corenman, MD         
Sub-Investigator: Ehrich Bean, PA-C         
Sub-Investigator: Eric Strauch, PA-C         
Sub-Investigator: Thos Evans, MD         
United States, Florida
The Spine Health Institute Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: Pamela Carrigan    407-303-2367    Pamela.Carrigan@flhosp.org   
Principal Investigator: Chetan Patel, MD         
Sub-Investigator: Emanuel King, MD         
Sub-Investigator: AJ Piovesan, PA-C         
Foundation for Orthopedic Research and Education Recruiting
Tampa, Florida, United States, 33637
Contact: Deborah Warren, RN, CCRC    813-978-9700 ext 6766    dwarren@foreonline.org   
Principal Investigator: John Small, MD         
Sub-Investigator: Cruz Christian, PA         
Sub-Investigator: Ann Growski, ARNP-C         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Lauren Glenney    404-778-6857    lauren.glenney@emory.edu   
Principal Investigator: Keith Michael, MD         
Sub-Investigator: Matthew Gary, MD         
Sub-Investigator: Dheera Ananthakrishnan, MD         
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 46032
Contact: Sheetal Vinayek, M.Sc    317-715-5897    svinayek@indianaspinegroup.com   
Principal Investigator: Joseph Smucker, MD         
Sub-Investigator: Paul Kraemer, MD         
Fort Wayne Orthopedics Terminated
Fort Wayne, Indiana, United States, 46804
United States, Kansas
The University of Kansas (KUMC) Recruiting
Kansas City, Kansas, United States, 66160
Contact: Eric Penner    913-945-8190    epenner@kumc.edu   
Principal Investigator: Paul Arnold, MD         
United States, Michigan
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Brad Allen    269-720-6759    ballen@c2rs.com   
Principal Investigator: Gregory Wiggins, MD         
Sub-Investigator: Chris Sloffer, MD         
Sub-Investigator: Joshua Ellwitz, MD         
United States, New York
Upstate Orthopedics Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig    315-464-8618    craigt@upstate.edu   
Principal Investigator: William Lavelle, MD         
Sub-Investigator: Richard Tallarico, MD         
United States, Texas
Seton Spine & Scoliosis Center Recruiting
Austin, Texas, United States, 78731
Contact: Devender Singh    512-324-3580 ext 15196    dpSingh@ascension.org   
Principal Investigator: Eeric Truumees, MD         
Sub-Investigator: John Stokes, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Lorrie Sipe    434-924-8775    LAG3K@hscmail.mcc.virginia.edu   
Principal Investigator: Mark E. Shaffrey, MD         
Sub-Investigator: Chun-Po Yen, MD         
Sub-Investigator: Avery L. Buchholz, MD         
Sponsors and Collaborators
Medtronic Spinal and Biologics

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Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT03118505     History of Changes
Other Study ID Numbers: P16-03
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Disease
Pathologic Processes