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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multi-Level Degenerative Lumbosacral Spinal Conditions
• Intervention / Treatment: Device: Infuse Bone Graft; Device: Medtronic DBM

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Beel Medical
    • Sacramento, California, United States, 95816
      • University of California, Davis
  • Colorado
    • Durango, Colorado, United States, 81301
      • Spine Colorado
    • Vail, Colorado, United States, 81657
      • The Steadman Clinic
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • The Spine Health Institute
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopedic Research and Education
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Orthopedics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas (KUMC)
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics
    • New York, New York, United States, 10034
      • New York-Presbyterian Hospital/Columbia University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Texas
    • Austin, Texas, United States, 78731
      • Seton Spine & Scoliosis Center
    • Plano, Texas, United States, 75075
      • American Neurospine Institute PLLC
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Infuse Bone Graft [4.2 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation	Device: Infuse Bone Graft; Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Experimental: Group 2; Infuse Bone Graft [6 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation	Device: Infuse Bone Graft; Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Experimental: Group 3; Infuse Bone Graft [12 mg per operative level] + Mastergraft Strip + local bone autograft + posterior fixation	Device: Infuse Bone Graft; Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
Active Comparator: Control; Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.	Device: Medtronic DBM; Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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).	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.	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.	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.	12 and 24 months
Back pain success at 12 and 24 months	Back pain success is defined as at least 30% improvement from baseline.	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.	12 and 24 months
Leg pain success at 12 and 24 months	Leg pain success is defined as at least 30% improvement from baseline.	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).	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.	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	24 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics
• Investigators: Principal Investigator: Chetan Patel, Spine Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: P16-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes