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
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: 24 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
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)
Time 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
Intraoperative variables
Surgery time, blood loss
Time frame: Intraoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.