ACTIVE_NOT_RECRUITING

Transforaminal Lumbar Interbody Fusion (TLIF)

Conditions

Degenerative Disease of the Lumbosacral Spine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. 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.

Official Title

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

Quick Facts

Study Start:2019-12-19

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04073563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

University of Arizona

Tucson, Arizona, 85724

United States

University of California Irvine

Irvine, California, 92617

United States

Memorial Health Services

Laguna Hills, California, 92653

United States

Cedars Sinai Spine Center

Los Angeles, California, 90048

United States

University of California Davis Medical Center

Sacramento, California, 95816

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson

Boulder, Colorado, 80303

United States

Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, 81657

United States

Hartford Hospital

Hartford, Connecticut, 06106

United States

Advent Health Altamonte Springs

Altamonte Springs, Florida, 32701

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Advent Health Orlando

Orlando, Florida, 32803

United States

Orlando Health

Orlando, Florida, 32806

United States

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032

United States

Indiana Spine Group

Carmel, Indiana, 46032

United States

OrthoIndy Northwest Office

Indianapolis, Indiana, 46278

United States

University of Iowa Hospitals and Clinic

Iowa City, Iowa, 52242

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

University of Michigan Health System

Ann Arbor, Michigan, 48109

United States

William Beaumont Hospital

Royal Oak, Michigan, 48073

United States

Mayo Clinic

Rochester, Minnesota, 55901

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

Hospital for Special Surgery

New York, New York, 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Mayfield Brain and Spine Clinic

Cincinnati, Ohio, 45209

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Penn State-Hershey

Hershey, Pennsylvania, 17033

United States

Rothman Institute

Philadelphia, Pennsylvania, 19107

United States

Semmes Murphey

Memphis, Tennessee, 38120

United States

Saint Thomas for Specialty Surgery

Nashville, Tennessee, 37203

United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209

United States

DFW Center for Spinal Disorder

Fort Worth, Texas, 76132

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

American Neurospine Institute

Plano, Texas, 75075

United States

University of Virginia - Clinical Trial Office

Charlottesville, Virginia, 22904

United States

University of Virginia - Health System

Charlottesville, Virginia, 22908

United States

Swedish Neuroscience

Seattle, Washington, 98122

United States

West Virginia University, 1 Medical Center Drive

Morgantown, West Virginia, 26506

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medtronic Spinal and Biologics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-19

Study Completion Date2028-07

Study Record Updates

Study Start Date2019-12-19

Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

Degenerative Disease of the Lumbosacral Spine