Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
Single Level TLIF surgery with Novosis Putty
Single Level TLIF surgery with standard of care bone graft
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGUC Davis
Sacramento, California, United States
RECRUITINGOverall Success
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
Time frame: 24 months after surgery
Fusion Success
Fusion Success at Month 12 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
Time frame: 12 months after surgery
Overall Success
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
Time frame: 6 and 12 months after surgery
Fusion Success
Fusion Success at Month 6 and Month 24 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
Time frame: 6 and 24 months after surgery
ODI score
Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 100(worst)
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
VAS score
Evaluate Visual Analog Scale(VAS) score/ none (0 mm) to an extreme amount of pain (100mm)
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University of Miami
Miami, Florida, United States
RECRUITINGThe Spine Center of Louisiana
Baton Rouge, Louisiana, United States
RECRUITINGLSU Health
Shreveport, Louisiana, United States
RECRUITINGParadigm Health System / Sterling Surgical Hospital
Slidell, Louisiana, United States
NOT_YET_RECRUITINGThe Ohio State University
Dublin, Ohio, United States
NOT_YET_RECRUITINGThomas Jefferson University - Department of Neurological Surgery
Philadelphia, Pennsylvania, United States
RECRUITINGAmerican Neurospine Institute, PLLC
Frisco, Texas, United States
RECRUITINGWest Virginia University - Department of Orthopaedics
Morgantown, West Virginia, United States
RECRUITINGTime frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
SF-12 score
Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Time to Fusion Success
Time frame: From surgery to 60 months after surgery
Time to First SSI
Time frame: From surgery to 60 months after surgery
Treatment satisfaction
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Intraoperative variables
Surgery time, blood loss
Time frame: intraoperative