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

Medtronic Spinal and Biologics17 sites in 1 country100 target enrollmentJune 29, 2017

ConditionsMulti-Level Degenerative Lumbosacral Spinal Conditions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multi-Level Degenerative Lumbosacral Spinal Conditions
Sponsor: Medtronic Spinal and Biologics
Enrollment: 100
Locations: 17
Primary Endpoint: Radiological Fusion Success
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 29, 2017

End Date

December 1, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≥
•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.
•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.

Exclusion Criteria

•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.
•Morbidly obese, as defined by a Body Mass Index (BMI) \>
•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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Neurological success rate at 12 and 24 months(12 and 24 months)
Back pain success at 12 and 24 months(12 and 24 months)
Leg pain success at 12 and 24 months(12 and 24 months)
ODI score at 12 and 24 months(12 and 24 months)
Leg pain score at 12 and 24 months(12 and 24 months)
AEs related to the PLF grafting material or posterior fixation up to 24 months(24 months)
Overall success rate at 12 and 24 months(12 and 24 months)
ODI success rate at 12 and 24 months(12 and 24 months)
Back pain score at 12 and 24 months(12 and 24 months)
Radiological fusion success rate at 24 months(24 months)
Secondary surgeries related to the PLF grafting material or posterior fixation up to 24 months(24 months)