None listed
Conditions
Interventions
Medical Device : This study is a multi-center, randomized, double-blinded, parallel, prospective, dose-finding clinical study.
If the subject voluntarily signed the informed consent form to participat
Sponsors
CGBio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult aged = 22 to = 80 years 2) Subjects whose skeletal maturation are confirmed by showing the result of Risser stage 5 in Risser classification, the Plain Radiography 3) 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). Symptomatic lumbar degeneration would be associated with the following comorbidities: l Herniated nucleus pulposus l Ligamentum flavum, annulus fibrosus or scarring/thickening of facet joint capsule l Facet joint degeneration and osteophyte formation l Spondylolysis with osteophyte l Disc degeneration or annular degeneration l Lumbar stenosis with compression on spinal cord or nerve root 4) Subjects with an ODI (Oswestry Disability Index) score of = 35/100 at screening 5) Subjects who were treated with non-surgical treatment/therapy for at least 3 months, but were judged to have failed treatment by the investigator 6) Subjects who are willing to participate in the study, comply with treatment and procedures, and visit the hospital for all observational evaluations 7) Subjects who voluntarily signed the informed consent form after hearing the explanation on objectives and methods of this study
Exclusion criteria
Exclusion criteria: 1) 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 2) Subjects who are considered that the symptoms occurring in the lumbar region are not occurred by disc degeneration 3) Subjects who are currently diagnosed with the following diseases at surgery: (1) Liver Disease: Liver cancer, liver cirrhosis, acute/chronic hepatitis (2) Kidney Disease: Acute/chronic renal failure, excretory dysfunction (3) Respiratory Disease: Active tuberculosis 4) Subjects with active malignancy 5) 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 6) 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) 7) Subjects with BMI = 35. 8) Subjects with spondylolisthesis/retrolisthesis with = Grade 3 in the target level 9) 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) 10) 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.) 11) 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.) 12) 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. 13) Subjects who smoke = 20 cigarettes a day 14) Subjects with autoimmune disease 15) Subjects who were exposed to rhBMP-2 in the past 16) Subjects who require to get fusion of two or more vertebral levels 17) Subjects who have a pseudoarthrosis after previous fusion 18) Subjects who had a history of at least one non-fusion spinal surgery on the level to be operated 19) 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. 20) Subjects who are pregnant at screening or who are planning to become pregnant during the study participation period. 21) Subjects who are currently lactating or who are planning to lactate during the study. 22) Subjects who participated in studies for other drugs, biologics, or medical devices within 6 months from the date of surgery 23) Subjects who are in a difficult situation to comply with study-related matters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall bone fusion rate (%);Overall fusion success rate (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall fusion success rate (%);Bone fusion rate based on CT (%);Bone fusion rate based on X-ray ;Time required for overall bone fusion ;Change and improvement rate of ODI compared to preoperative score;Change of SF-12 scores compared to preoperative score;Change and improvement rate of NRS scores ;Improvement rate of neurological symptoms ;Satisfaction rate of the subject | — |
Countries
Korea, Republic of
Contacts
Public ContactShin Dong Ah
Yonsei University Health System, Severance Hospital
Outcome results
None listed