Eficácia e segurança da massa Novosis para doenças lombares degenerativas

Inclusion Criteria:

• Adult aged ≥ 22 to ≤ 80 years
• Subjects whose skeletal maturation are confirmed by showing the result of Risser stage 5 in Risser classification, the Plain Radiography
• Subjects diagnosed with disc degeneration in the single level (L2-S1) lumbar spine along with spondylolisthesis of Meyerding grade 1 (degree of translocation: 0- <25%) or 2 (degree of translocation: 25- <50%) based on the results of radiological examination (CT, MRI, X-ray).
• Subjects with an ODI (Oswestry Disability Index) score of ≥ 35/100 at screening
• Subjects who were treated with non surgical treatment/therapy for at least 3 months, but were judged to have failed treatment by the investigator
• Subjects who are willing to participate in the study, comply with treatment and procedures, and visit the hospital for all observational evaluations
• Subjects who voluntarily signed the informed consent form after hearing the explanation on objectives and methods of this study

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