Clinical trial NCT03118505: A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multi-Level Degenerative Lumbosacral Spinal Conditions
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Degenerative lumbar spine condition:

   1. Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1; and
   2. 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).
2. Preoperative ODI score ≥40.
3. Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
4. Most inferior treated spinal level is able to accommodate an interbody fusion device.
5. ≥21 years of age at the time of signing the informed consent.
6. Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
7. Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.

Exclusion Criteria:

1. 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.)
2. Prior lumbar disc arthroplasty.
3. 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.
4. Planned use of an internal or external bone growth stimulator.
5. Lumbar scoliosis \>30 degrees.
6. Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture.
7. Morbidly obese, as defined by a Body Mass Index (BMI) \>40.
8. Presence of active malignancy or prior history of malignancy.
9. Overt or active bacterial infection, either local or systemic.
10. 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.
11. Comorbidities precluding subject from being a surgical candidate.
12. History of autoimmune disease known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
13. History of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
14. 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).
15. 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 \[PEEK\]).
16. History of any allergy resulting in anaphylaxis.
17. Is a prisoner.
18. Is mentally incompetent. If questionable, obtain psychiatric consult.
19. 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.
20. Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for one year following surgery.
21. 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.

Primary outcomes:
measure: Radiological Fusion Success
timeFrame: 12 months
Secondary outcomes:
measure: Overall success rate at 12 and 24 months
timeFrame: 12 and 24 months
measure: ODI score at 12 and 24 months
timeFrame: 12 and 24 months
measure: ODI success rate at 12 and 24 months
timeFrame: 12 and 24 months
measure: Neurological success rate at 12 and 24 months
timeFrame: 12 and 24 months
measure: Back pain score at 12 and 24 months
timeFrame: 12 and 24 months
measure: Back pain success at 12 and 24 months
timeFrame: 12 and 24 months
measure: Leg pain score at 12 and 24 months
timeFrame: 12 and 24 months
measure: Leg pain success at 12 and 24 months
timeFrame: 12 and 24 months
measure: Radiological fusion success rate at 24 months
timeFrame: 24 months
measure: AEs related to the PLF grafting material or posterior fixation up to 24 months
timeFrame: 24 months
measure: Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Vail
country: United States
facility: The Steadman Clinic
state: Colorado
city: Altamonte Springs
country: United States
facility: The Spine Health Institute
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopedic Research and Education
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedics
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas (KUMC)
state: Kansas
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: East Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Austin
country: United States
facility: Seton Spine & Scoliosis Center
state: Texas
city: Plano
country: United States
facility: American Neurospine Institute PLLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Spine Health Institute
name: Chetan Patel
role: PRINCIPAL_INVESTIGATOR
References: