Degenerative Disease of the Lumbosacral SpineTLIFNCT04073563

Transforaminal Lumbar Interbody Fusion (TLIF)

A study testing Infuse™ Bone Graft (Infuse™) and Intervertebral body fusion device and Medtronic posterior Fixation Systems in people with Degenerative Disease of the Lumbosacral Spine, run by Medtronic Spinal and Biologics at 46 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disease of the Lumbosacral Spine
What is being tested?: Infuse™ Bone Graft (Infuse™) and Intervertebral body fusion device and Medtronic posterior Fixation Systems
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 46 sitesin 2 countries
Study dates: 19 Dec 2019to Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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:

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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.
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.

Who cannot join

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.)

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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.

Trial locations and contacts

46 sites in 2 countries.

Country

City, postcode or hospital

46 sites in 2 countries

United States43 sites

Advent Health Altamonte Springs
Altamonte Springs, Florida, 32701
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson
Boulder, Colorado, 80303
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
Indiana Spine Group
Carmel, Indiana, 46032
University of Virginia - Clinical Trial Office
Charlottesville, Virginia, 22904
University of Virginia - Health System
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Mayfield Brain and Spine Clinic
Cincinnati, Ohio, 45209
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
DFW Center for Spinal Disorder
Fort Worth, Texas, 76132
Hartford Hospital
Hartford, Connecticut, 06106
Penn State-Hershey
Hershey, Pennsylvania, 17033
Houston Methodist Hospital
Houston, Texas, 77030
OrthoIndy Northwest Office
Indianapolis, Indiana, 46278
University of Iowa Hospitals and Clinic
Iowa City, Iowa, 52242
University of California Irvine
Irvine, California, 92617
Mayo Clinic
Jacksonville, Florida, 32224
Memorial Health Services
Laguna Hills, California, 92653
Cedars Sinai Spine Center
Los Angeles, California, 90048
Semmes Murphey
Memphis, Tennessee, 38120
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University, 1 Medical Center Drive
Morgantown, West Virginia, 26506
Saint Thomas for Specialty Surgery
Nashville, Tennessee, 37203
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Hospital for Special Surgery
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Advent Health Orlando
Orlando, Florida, 32803
Orlando Health
Orlando, Florida, 32806
Rothman Institute
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Phoenix, Arizona, 85054
American Neurospine Institute
Plano, Texas, 75075
Mayo Clinic
Rochester, Minnesota, 55901
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California Davis Medical Center
Sacramento, California, 95816
Swedish Neuroscience
Seattle, Washington, 98122
Baystate Medical Center
Springfield, Massachusetts, 01199
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
Montefiore Medical Center
The Bronx, New York, 10467
University of Arizona
Tucson, Arizona, 85724
Vail-Summit Orthopaedics and Neurosurgery
Vail, Colorado, 81657

Other trials in United States

China3 sites

Peking University Third Hospital
Beijing
West China Hospital of Sichuan University
Chengdu
Chongqing Xinqiao Hospital Second Affiliated Hospital of Army Medical University
Chongqing, 400000

Other trials in China

About this study

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

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
Being tested: Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Infuse™ Bone Graft (Infuse™)Device
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
Intervertebral body fusion device and Medtronic posterior Fixation SystemsDevice
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System

Study groups in NCT04073563
Study group	Role	What they receive
Group #1	Experimental	Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed Receives: 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 Receives: 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. Receives: Device: Intervertebral body fusion device and Medtronic posterior Fixation Systems

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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).
Measured: 24 Months

Secondary outcomes (7)

Time to fusion
The first time point when a subject's fusion status has been determined to be a success per the fusion success criteria
Measured: From surgery to 24 Months
ODI success
The self-administered Oswestry Disability Index (ODI) will be used. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score ≥ 15 points
Measured: 24 months
Leg pain success
Numerical rating scales (NRS 0-10) will be used to measure leg pain, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be. Success for leg pain is defined as at least 30% improvement from pre-operative score: (Preoperative Score - Postoperative Score) / Preoperative Score ≥ 30%
Measured: 24 months
Back pain success
Numerical rating scales (NRS 0-10) will be used to measure back pain, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be". Success for back pain is defined as at least 30% improvement from pre-operative score: (Preoperative Score - Postoperative Score) / Preoperative Score ≥ 30%
Measured: 24 months
Neurological success
Overall neurological success is defined as maintenance or improvement in four key neurological assessments: motor function, sensory function, reflexes, and straight leg raise. In order to be considered a success, each element in the motor, sensory, reflexes, and straight leg raise examinations must remain the same or improve from the time of the preoperative evaluation to the time period evaluated. Therefore, if any one motor, sensory, or reflexes element does not stay the same or improve, then a subject will not be considered a success for neurological status.
Measured: 24 months
Serious Adverse Events
Serious Adverse Events related to TLIF grafting material or interbody device up to 24 months
Measured: up to 24 months
Secondary Surgery
Secondary surgeries that are classified as a "failure", defined as any secondary surgeries at index level(s) "related" to TLIF grafting material or interbody device.
Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 2019Jul 2028

First posted29 Aug 2019
Study start19 Dec 2019
Primary completionJul 2027 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Disease of the Lumbosacral SpineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04073563
Sponsor's protocol ID: MDT17074SD1706
Acronym: TLIF
Status last verified: Feb 2026
First submitted: 27 Aug 2019
Last updated: 4 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04073563
Acronym / sponsor ID: TLIF / MDT17074SD1706
Conditions: Degenerative Disease of the Lumbosacral Spine
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
Study start: 19 Dec 2019 (actual)
Primary completion: Jul 2027 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 29 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Group #1	Experimental	Device: Infuse™ Bone Graft (Infuse™), Device: Intervertebral body fusion device and Medtronic posterior Fixation SystemsInvestigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Group #2	Experimental	Device: Infuse™ Bone Graft (Infuse™), Device: Intervertebral body fusion device and Medtronic posterior Fixation SystemsInvestigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Control	Active comparator	Device: Intervertebral body fusion device and Medtronic posterior Fixation SystemsLocal bone autograft and supplemented with cancellous allograft as needed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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:
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:
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.

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Infuse™ Bone Graft (Infuse™)(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))	Device	Group #1, Group #2
Intervertebral body fusion device and Medtronic posterior Fixation SystemsAdaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System	Device	Control, Group #1, Group #2

Primary outcome

Overall success at 24 months
Time frame: 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
Fusion success at 24 months
Time frame: 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).

7 secondary outcomes

Time to fusion
Time frame: From surgery to 24 Months
ODI success
Time frame: 24 months
Leg pain success
Time frame: 24 months
Back pain success
Time frame: 24 months
Neurological success
Time frame: 24 months
Serious Adverse Events
Time frame: up to 24 months
Secondary Surgery
Time frame: up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

46 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall success at 24 months (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04073563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.