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Active, not recruitingNCT03118505Updated Jun 25, 2026

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

An interventional study of Infuse Bone Graft and Medtronic DBM in Multi-Level Degenerative Lumbosacral Spinal Conditions, sponsored by Medtronic Spinal and Biologics. Active, not recruiting at 17 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Medtronic Spinal and Biologics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multi-Level Degenerative Lumbosacral Spinal Conditions
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group 1

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

    Device: Infuse Bone Graft

  • Experimental
    Group 2

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

    Device: Infuse Bone Graft

  • Experimental
    Group 3

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

    Device: Infuse Bone Graft

  • Active comparator
    Control

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

    Device: Medtronic DBM

Interventions

  • DeviceInfuse Bone Graft

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

  • DeviceMedtronic DBM

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

05

What researchers measure

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).

    Time frame: 12 months

Secondary outcomes

  1. Overall success rate at 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."

    Time frame: 12 and 24 months

  2. ODI score at 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).

    Time frame: 12 and 24 months

  3. ODI success rate at 12 and 24 months

    ODI success is defined as at least a 15-point improvement from baseline.

    Time frame: 12 and 24 months

  4. Neurological success rate at 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.

    Time frame: 12 and 24 months

  5. Back pain score at 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.

    Time frame: 12 and 24 months

  6. Back pain success at 12 and 24 months

    Back pain success is defined as at least 30% improvement from baseline.

    Time frame: 12 and 24 months

  7. Leg pain score at 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.

    Time frame: 12 and 24 months

  8. Leg pain success at 12 and 24 months

    Leg pain success is defined as at least 30% improvement from baseline.

    Time frame: 12 and 24 months

  9. Radiological fusion success rate at 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).

    Time frame: 24 months

  10. AEs related to the PLF grafting material or posterior fixation up to 24 months

    A summary of AEs related to the PLF grafting material or posterior fixation up to 24 months.

    Time frame: 24 months

  11. Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months

    A summary of secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months

    Time frame: 24 months

06

Study locations

17 sites
  • University of California, Davis
    Sacramento, California 95816, United States
  • Spine Colorado
    Durango, Colorado 81301, United States
  • The Steadman Clinic
    Vail, Colorado 81657, United States
  • The Spine Health Institute
    Altamonte Springs, Florida 32701, United States
  • Foundation for Orthopedic Research and Education
    Tampa, Florida 33637, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Indiana Spine Group
    Carmel, Indiana 46032, United States
  • Fort Wayne Orthopedics
    Fort Wayne, Indiana 46804, United States
  • The University of Kansas (KUMC)
    Kansas City, Kansas 66160, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • Upstate Orthopedics
    East Syracuse, New York 13057, United States
  • New York-Presbyterian Hospital/Columbia University
    New York, New York 10034, United States
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Seton Spine & Scoliosis Center
    Austin, Texas 78731, United States
  • American Neurospine Institute PLLC
    Plano, Texas 75075, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22903, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
07

Registry details

Key details

Study ID
NCT03118505
Lead sponsor
Medtronic Spinal and Biologics
Responsible party
Sponsor
First posted
Apr 18, 2017
Start date
Jun 29, 2017
Primary completion
Jul 1, 2025
Completion
Dec 2026 (estimated)
Last update
Jun 25, 2026

Study contacts

Chetan Patel
principal investigator · Spine Health Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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