Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

Exclusion Criteria

• •Subjects who have a history of medical device application (spinal instrumentation, for example, anterior disc replacement, interspinous device) to the target site or interbody fusion
• •Subjects who are considered that the symptoms occurring in the lumbar region are not occurred by disc degeneration
• •Subjects with active malignancy
• •Subjects with a documented history of drug abuse (e.g., psychotropic drugs including narcotic analgesics and drugs with high dependence such as alcohol) within the last 6 months
• •Subjects with a history of endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler Danlos disease, or osteogenesis imperfecta)
• •Subjects with BMI ≥ 35
• •Subjects with spondylolis thesis/retrolisthesis with ≥ Grade 3 in the target level
• •Subjects with a local acute infection at the current surgical site or active systemic infection (e.g., viral infections such as AIDS, HIV or hepatitis)
• •Subjects with a history of metabolic or endocrine diseases known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers Danlos disease, osteogenesis imperfecta, fibrous dysplasia, etc.)
• •Subjects with osteoporosis with a mean lumbar spine T-score of ≤ 2.5 on the DEXA bone density test and with a history of osteoporotic fractures (wrist fractures, femur fractures, lumbar spine fractures, etc.)
• •Subjects who need to administer drugs that inhibit bone metabolism within 2 weeks after surgery, or Subjects who need to receive post operative drugs that are expected to interfere with bone fusion, such as steroids
• •Subjects who smoke ≥ 20 cigarettes a day
• •Subjects with autoimmune disease
• •Subjects who were exposed to rhBMP 2 in the past
• •Subjects who require to get fusion of two or more vertebral levels
• •Subjects who have a pseudoarthrosis after previous fusion
• •Subjects who had a history of at least one non fusion spinal surgery on the level to be operated
• •Subjects who are considered to have a disease that hinders the accurate evaluation (e.g., neuromuscular disease, serious psychiatric disease) at the discretion of the investigator
• •Subjects who are pregnant at screening or who are planning to become pregnant during the study participation period
• •Subjects who are currently lactating or who are planning to lactate during the study
• •Subjects who participated in studies for other drugs, biologics, or medical devices within 6 months from the date of surgery
• •Subjects who are in a difficult situation to comply with study related matters