This clinical study aims to evaluate the efficacy and safety of NOVOSIS PUTTY for bone fusion in patients requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease.
The Subject is a patient requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease. This clinical study aims to compare and evaluate the efficacy and safety of three dose groups of NOVOSIS PUTTY for bone fusion compared to the autologous bone in patients requiring posterior instrumentation and TLIF in the single level between L2 and S1(L2-S1) due to degenerative lumbar disease. * Control Group (n=12): Local autologous bone * Experimental Group 1 (n=12): Dose 1 * Experimental Group 2 (n=12): Dose 2 * Experimental Group 3 (n=12): Dose 3
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
NOVOSIS PUTTY is a product composed of recombinant human bone morphogenetic protein-2 and β-tricalcium phosphate/hydrogel complex.
Severance hospital
Seoul, South Korea
Overall bone fusion rate
Meet the definition of bone fusion based on CT and the definition of bone fusion based on X-ray simultaneously.
Time frame: 12 months after surgery
Overall fusion success rate
Meet all of the following conditions: 1. Success in ODI 2. Overall Bone Fusion Success 3. Neurological Success 4. No serious adverse event 5. No re-operation
Time frame: 12 months after surgery
Overall fusion success rate
Meet all of the following conditions: 1. Success in ODI 2. Overall Bone Fusion Success 3. Neurological Success 4. No serious adverse event 5. No re-operation
Time frame: 6 and 24 months after surgery
Bone fusion rate
Bone fusion rate based on CT, X-ray
Time frame: 6, 12, and 24 months after surgery
Oswestry Disability Index(ODI)
Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 50(worst)
Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery
SF-12 scores (general condition test)
Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)
Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery
Numerical Rating Scale (NRS)
Evaluate Numerical Rating Scale (NRS) scores / lowest 0(best) to highest 30(worst)
Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery
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Neurological Symptoms
Evaluate Neurological Symptoms test/ check among the 3 questions(Worsened/ Constent/Improved) best is imporved, worst is worsened
Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery
Satisfaction rate
Evaluate Satisfaction rate score / lowest 0(worst) to highest 3(best)
Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery