A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
NCT ID: NCT03118505
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2017-06-29
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
NCT01494493
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
NCT05405374
Transforaminal Lumbar Interbody Fusion (TLIF)
NCT04073563
INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
NCT01491542
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
NCT01415908
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Infuse Bone Graft \[4.2 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Group 2
Infuse Bone Graft \[6 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Group 3
Infuse Bone Graft \[12 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Control
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.
Medtronic DBM
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infuse Bone Graft
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Medtronic DBM
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chetan Patel
Role: PRINCIPAL_INVESTIGATOR
Spine Health Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P16-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.