Transforaminal Lumbar Interbody Fusion (TLIF)

NCT04073563 | Active Not Recruiting DMC FDA Device

• 1 other identifier: MDT17074SD1706
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 46

Brief Summary

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.

Conditions

Degenerative Disease of the Lumbosacral Spine

Outcome Measures

Primary Outcomes (2)

• Overall success at 24 months

  Overall success is defined as the participant who meet the following five criteria: * Pain/disability (ODI) success, defined as at least a 15-point improvement from baseline; * Fusion success as defined in primary outcome 2. * Neurological success, defined as maintenance or improvement in neurological status; * No SAE related to the TLIF grafting material or interbody device; and * No secondary surgeries at index level that are related to the TLIF grafting material or interbody device

  24 months

• Fusion success at 24 months

  Fusion success at each treatment level must demonstrate: * Evidence of bridging bone via CT. Solid fusion is based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level(s) in at least 1 of the following locations: right lateral, left lateral, anterior, posterior, or through the intervertebral body fusion device. * No evidence of motion as defined by less than 2 mm translational motion and less than 3° in angular motion at each treated level (flexion/extension radiographs).

  24 Months

Secondary Outcomes (7)

• Time to fusion

  From surgery to 24 Months

• ODI success

  24 months

• Leg pain success

  24 months

• Back pain success

  24 months

• Neurological success

  24 months

Study Arms (3)

Group #1

EXPERIMENTAL

Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Device: Infuse™ Bone Graft (Infuse™); Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems

Group #2

EXPERIMENTAL

Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Device: Infuse™ Bone Graft (Infuse™); Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems

Control

ACTIVE COMPARATOR

Local bone autograft and supplemented with cancellous allograft as needed.

Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems

Interventions

Infuse™ Bone Graft (Infuse™) DEVICE

(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))

Group #1; Group #2

Intervertebral body fusion device and Medtronic posterior Fixation Systems DEVICE

Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System

Control; Group #1; Group #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
• 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:
• 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
• Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (46)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California Irvine

Irvine, California, 92617, United States

Location

Memorial Health Services

Laguna Hills, California, 92653, United States

Location

Cedars Sinai Spine Center

Los Angeles, California, 90048, United States

Location

University of California Davis Medical Center

Sacramento, California, 95816, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

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

Boulder, Colorado, 80303, United States

Location

Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, 81657, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Advent Health Altamonte Springs

Altamonte Springs, Florida, 32701, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

OrthoIndy Northwest Office

Indianapolis, Indiana, 46278, United States

Location

University of Iowa Hospitals and Clinic

Iowa City, Iowa, 52242, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Mayfield Brain and Spine Clinic

Cincinnati, Ohio, 45209, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State-Hershey

Hershey, Pennsylvania, 17033, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Semmes Murphey

Memphis, Tennessee, 38120, United States

Location

Saint Thomas for Specialty Surgery

Nashville, Tennessee, 37203, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

Location

DFW Center for Spinal Disorder

Fort Worth, Texas, 76132, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

American Neurospine Institute

Plano, Texas, 75075, United States

Location

University of Virginia - Clinical Trial Office

Charlottesville, Virginia, 22904, United States

Location

University of Virginia - Health System

Charlottesville, Virginia, 22908, United States

Location

Swedish Neuroscience

Seattle, Washington, 98122, United States

Location

West Virginia University, 1 Medical Center Drive

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Peking University Third Hospital

Beijing, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Chongqing Xinqiao Hospital Second Affiliated Hospital of Army Medical University

Chongqing, 400000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: December 19, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (3); US (43)