Multi-Level Degenerative Lumbosacral Spinal ConditionsNCT03118505
A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
A study testing Infuse Bone Graft and Medtronic DBM in people with Multi-Level Degenerative Lumbosacral Spinal Conditions, run by Medtronic Spinal and Biologics at 17 sites in United States.
Trial summary
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multi-Level Degenerative Lumbosacral Spinal Conditions
- What is being tested?
- Infuse Bone Graft and Medtronic DBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesUnited States
- Study dates
- 29 Jun 2017to Dec 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative lumbar spine condition:
- Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1; and
- Diagnosed with: instability (up to and including Grade 2 spondylolisthesis, retrolisthesis, or lateral listhesis), stenosis with documented pre-operative instability, and/or recurrent disc herniation, any of which may have possible concomitant lumbar degenerative deformity (Cobb angle ≤ 30 degrees).
- Preoperative ODI score ≥40.
- Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
- Most inferior treated spinal level is able to accommodate an interbody fusion device.
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- ≥21 years of age at the time of signing the informed consent.
- Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
- Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.
Who cannot join
- Prior spinal fusion surgical procedure at the involved or adjacent spinal levels. (Prior non-fusion surgery at the target levels, including discectomy and/or single-level foraminotomy or laminectomy, is allowed.)
- Prior lumbar disc arthroplasty.
- Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis >30 degrees.
- Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture.
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- Morbidly obese, as defined by a Body Mass Index (BMI) >40.
- Presence of active malignancy or prior history of malignancy.
- Overt or active bacterial infection, either local or systemic.
- Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
- Comorbidities precluding subject from being a surgical candidate.
- History of autoimmune disease known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- History of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- History of exposure to any recombinant proteins used for bone formation (i.e., 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).
- 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; gentamicin or glycerol (which may be present in trace amounts in the DBM products); and/or instrumentation materials (titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone [PEEK]).
- History of any allergy resulting in anaphylaxis.
- Is a prisoner.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for one year following surgery.
- Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Spine Health Institute
Altamonte Springs, Florida, 32701
Emory University
Atlanta, Georgia, 30329
Seton Spine & Scoliosis Center
Austin, Texas, 78731
Indiana Spine Group
Carmel, Indiana, 46032
University of Virginia Health System
Charlottesville, Virginia, 22903
University of Virginia
Charlottesville, Virginia, 22903
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Spine Colorado
Durango, Colorado, 81301
Upstate Orthopedics
East Syracuse, New York, 13057
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
The University of Kansas (KUMC)
Kansas City, Kansas, 66160
New York-Presbyterian Hospital/Columbia University
New York, New York, 10034
American Neurospine Institute PLLC
Plano, Texas, 75075
University of California, Davis
Sacramento, California, 95816
Foundation for Orthopedic Research and Education
Tampa, Florida, 33637
The Steadman Clinic
Vail, Colorado, 81657
About this study
Official title: A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
- Being tested
- Infuse Bone Graft, Medtronic DBM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infuse Bone GraftDevice
Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Medtronic DBMDevice
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Infuse Bone Graft [4.2 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation Receives: Device: Infuse Bone Graft |
| Group 2 | Experimental | Infuse Bone Graft [6 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation Receives: Device: Infuse Bone Graft |
| Group 3 | Experimental | Infuse Bone Graft [12 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation Receives: Device: Infuse Bone Graft |
| Control | Active comparator | Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation. Receives: Device: Medtronic DBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Fusion Success
Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level:
- Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT);
- No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and
- Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass (all radiograph views).
Measured: 12 months
Secondary outcomes (11)
Overall success rate at 12 and 24 months
Overall success is defined as the participant who meet the following five criteria:
- Radiographic success, defined as radiological fusion success in the posterolateral space;
- Pain/disability (ODI) success, defined as at least a 15-point improvement from baseline;
- Neurological success, defined as maintenance or improvement in neurological status;
- No SAE related to the PLF grafting material or posterior fixation; and
- No secondary surgeries classified as a "failure."
Measured: 12 and 24 months
ODI score at 12 and 24 months
The self-administered Oswestry Disability Index (ODI) Questionnaire (Version 2.1) will be used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Measured: 12 and 24 months
ODI success rate at 12 and 24 months
ODI success is defined as at least a 15-point improvement from baseline.
Measured: 12 and 24 months
Neurological success rate at 12 and 24 months
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.
Measured: 12 and 24 months
Back pain score at 12 and 24 months
Numerical rating scales, adapted in part from Measuring Health, will be used to evaluate back pain. The back pain score (0-20) is the summation of pain intensity (0-10) and duration (0-10) scores.
Measured: 12 and 24 months
Back pain success at 12 and 24 months
Back pain success is defined as at least 30% improvement from baseline.
Measured: 12 and 24 months
Leg pain score at 12 and 24 months
Numerical rating scales, adapted in part from Measuring Health, will be used to evaluate leg pain. The leg pain score (0-20) is the summation of pain intensity (0-10) and duration (0-10) scores.
Measured: 12 and 24 months
Leg pain success at 12 and 24 months
Leg pain success is defined as at least 30% improvement from baseline.
Measured: 12 and 24 months
Radiological fusion success rate at 24 months
Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level:
- Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT);
- No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and
- Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass (all radiograph views).
Measured: 24 months
AEs related to the PLF grafting material or posterior fixation up to 24 months
A summary of AEs related to the PLF grafting material or posterior fixation up to 24 months.
Measured: 24 months
Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months
A summary of secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start29 Jun 2017
- Primary completion1 Jul 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-Level Degenerative Lumbosacral Spinal ConditionsStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chetan Patel, Principal investigator, Spine Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118505
- Sponsor's protocol ID
- P16-03
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2017
- Last updated
- 25 Jun 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
- ClinicalTrials.gov ID
- NCT03118505
- Acronym / sponsor ID
- P16-03
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Apr 2017 (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.
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Infuse Bone GraftInfuse Bone Graft [4.2 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation |
| Group 2 | Experimental | Device: Infuse Bone GraftInfuse Bone Graft [6 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation |
| Group 3 | Experimental | Device: Infuse Bone GraftInfuse Bone Graft [12 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation |
| Control | Active comparator | Device: Medtronic DBMMedtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Degenerative lumbar spine condition:
- Preoperative ODI score ≥40.
- Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
- Most inferior treated spinal level is able to accommodate an interbody fusion device.
- ≥21 years of age at the time of signing the informed consent.
Key exclusion criteria (21 listed)
- Prior spinal fusion surgical procedure at the involved or adjacent spinal levels. (Prior non-fusion surgery at the target levels, including discectomy and/or single-level foraminotomy or laminectomy, is allowed.)
- Prior lumbar disc arthroplasty.
- Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level.
- Planned use of an internal or external bone growth stimulator.
- 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 GraftInfuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation | Device | Group 1, Group 2, Group 3 |
| Medtronic DBMMedtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation | Device | Control |
Primary outcome
Radiological Fusion Success
Time frame: 12 months
Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level: * Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT); * No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and * Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass (all radiograph views).
11 secondary outcomes
Overall success rate at 12 and 24 months
Time frame: 12 and 24 months
ODI score at 12 and 24 months
Time frame: 12 and 24 months
ODI success rate at 12 and 24 months
Time frame: 12 and 24 months
Neurological success rate at 12 and 24 months
Time frame: 12 and 24 months
Back pain score at 12 and 24 months
Time frame: 12 and 24 months
Back pain success at 12 and 24 months
Time frame: 12 and 24 months
Leg pain score at 12 and 24 months
Time frame: 12 and 24 months
Leg pain success at 12 and 24 months
Time frame: 12 and 24 months
Radiological fusion success rate at 24 months
Time frame: 24 months
AEs related to the PLF grafting material or posterior fixation up to 24 months
Time frame: 24 months
Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months
Time frame: 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 25 Jun 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.
Chetan Patel principal investigator
Spine Health Institute
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infuse Bone Graft and Medtronic DBM in people with Multi-Level Degenerative Lumbosacral Spinal Conditions, run by Medtronic Spinal and Biologics at 17 sites in United States.
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 9 inclusion and 21 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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?
Radiological Fusion Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.