New bone graft study aims to improve spine surgery outcomes

NCT ID NCT04073563

Disease control Sponsor: Medtronic Spinal and Biologics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special bone graft (Infuse) helps spine bones fuse together better after back surgery. About 600 adults with degenerative spine disease will be followed for two years. The goal is to see if the graft reduces pain, improves function, and safely helps bones heal.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A subject must meet all of the following inclusion criteria to participate in this study: * I.1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by: 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. Has to meet either inclusion criteria 5 or 6 to qualify for the study: * 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: A subject will be excluded from participating in this study for any of the following reasons: * 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.

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Conditions

The condition(s) this trial relates to.

lumbar disk degenerative disorder lumbar disk disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disease of the lumbosacral spine

Contacts and locations

Locations

Advent Health Altamonte Springs

Altamonte Springs, Florida, 32701, United States
Advent Health Orlando

Orlando, Florida, 32803, United States
American Neurospine Institute

Plano, Texas, 75075, United States
Baystate Medical Center

Springfield, Massachusetts, 01199, United States
Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson

Boulder, Colorado, 80303, United States
Cedars Sinai Spine Center

Los Angeles, California, 90048, United States
Chongqing Xinqiao Hospital Second Affiliated Hospital of Army Medical University

Chongqing, 400000, China
DFW Center for Spinal Disorder

Fort Worth, Texas, 76132, United States
Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States
Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States
Hartford Hospital

Hartford, Connecticut, 06106, United States
Hospital for Special Surgery

New York, New York, 10021, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Indiana Spine Group

Carmel, Indiana, 46032, United States
Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States
Mayfield Brain and Spine Clinic

Cincinnati, Ohio, 45209, United States
Mayo Clinic

Phoenix, Arizona, 85054, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55901, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Health Services

Laguna Hills, California, 92653, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Orlando Health

Orlando, Florida, 32806, United States
OrthoIndy Northwest Office

Indianapolis, Indiana, 46278, United States
Peking University Third Hospital

Beijing, China
Penn State-Hershey

Hershey, Pennsylvania, 17033, United States
Rothman Institute

Philadelphia, Pennsylvania, 19107, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Thomas for Specialty Surgery

Nashville, Tennessee, 37203, United States
Semmes Murphey

Memphis, Tennessee, 38120, United States
Swedish Neuroscience

Seattle, Washington, 98122, United States
Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
University of Arizona

Tucson, Arizona, 85724, United States
University of California Davis Medical Center

Sacramento, California, 95816, United States
University of California Irvine

Irvine, California, 92617, United States
University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States
University of Iowa Hospitals and Clinic

Iowa City, Iowa, 52242, United States
University of Michigan Health System

Ann Arbor, Michigan, 48109, United States
University of Virginia - Clinical Trial Office

Charlottesville, Virginia, 22904, United States
University of Virginia - Health System

Charlottesville, Virginia, 22908, United States
Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, 81657, United States
West China Hospital of Sichuan University

Chengdu, China
West Virginia University, 1 Medical Center Drive

Morgantown, West Virginia, 26506, United States
William Beaumont Hospital

Royal Oak, Michigan, 48073, United States