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
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ACTIVE_NOT_RECRUITING
NA
600 participants
INTERVENTIONAL
2019-12-19
2028-07-31
Brief Summary
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Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group #1
Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Group #2
Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Control
Local bone autograft and supplemented with cancellous allograft as needed.
Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Interventions
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Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Eligibility Criteria
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Inclusion Criteria
1. History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
2. History of neurogenic claudication.
* I.2. Has a history of low back pain.
* I.3. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
1. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
2. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
3. Recurrent disc herniation
* I.4. Has preoperative Oswestry Disability Index score ≥ 35.
* I.5. Has preoperative back and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.
* I.6. Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
* I.7. Is at least 18 years of age and skeletally mature at the time of surgery.
* I.8. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
* I.9. Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.
Exclusion Criteria
* E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
* E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
* E.3 Planned use of an internal or external bone growth stimulator.
* E.4 Lumbar scoliosis \>30 degrees.
* E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)
* E.6 Morbidly obese, as defined by a Body Mass Index (BMI) \>40.
* E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
* E.8 Overt or active bacterial infection, either local to surgical space or systemic.
* E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.
* This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
* Use of steroidal inhalers is allowed pre- and post-operatively
* Short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks. Use of steroids for longer than two weeks post-operatively through the 24-month follow-up visit is prohibited.
* E.10 Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
* E.11 Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
* E.12 Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
* E.13 Known exposure to any recombinant proteins used for bone formation (e.g., 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).
* E.14 Known 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; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
* E.15 History of any allergy resulting in anaphylaxis.
* E.16 Is a prisoner.
* E.17 Is mentally incompetent. If questionable, obtain psychiatric consult.
* E.18 Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
* E.19 Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
* E.20 A documented diagnosis of substance use disorder as defined by the DSM-5.22 (Nicotine use is allowed.)
* E.21 Pursuing worker's compensation or active litigation for spinal fusion procedure.
* E.22 Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.
18 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California Irvine
Irvine, California, United States
Memorial Health Services
Laguna Hills, California, United States
Cedars Sinai Spine Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson
Boulder, Colorado, United States
Vail-Summit Orthopaedics and Neurosurgery
Vail, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Advent Health Altamonte Springs
Altamonte Springs, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Orlando Health
Orlando, Florida, United States
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
Indiana Spine Group
Carmel, Indiana, United States
OrthoIndy Northwest Office
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinic
Iowa City, Iowa, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital for Special Surgery
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Mayfield Brain and Spine Clinic
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Penn State-Hershey
Hershey, Pennsylvania, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Semmes Murphey
Memphis, Tennessee, United States
Saint Thomas for Specialty Surgery
Nashville, Tennessee, United States
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States
DFW Center for Spinal Disorder
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
American Neurospine Institute
Plano, Texas, United States
University of Virginia - Clinical Trial Office
Charlottesville, Virginia, United States
University of Virginia - Health System
Charlottesville, Virginia, United States
Swedish Neuroscience
Seattle, Washington, United States
West Virginia University, 1 Medical Center Drive
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Peking University Third Hospital
Beijing, , China
West China Hospital of Sichuan University
Chengdu, , China
Chongqing Xinqiao Hospital Second Affiliated Hospital of Army Medical University
Chongqing, , China
Countries
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Other Identifiers
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MDT17074SD1706
Identifier Type: -
Identifier Source: org_study_id
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