None listed
Conditions
Interventions
Medical Device : In this clinical trial, all subjects were subjected
to Transforamenal Lumbar Interbody Fusion. Subjects assigned to the experimental
group according to randomization were transplant
Sponsors
Cellumed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 20 to 80 years 2. Patients with 1- or 2-level degenerative disc disease between L3 and S1 3. Patients who require fixation surgery and have a life expectancy of 2 years or more 4. Participants who voluntarily agree to study participation and sign a written informed consent form 5. Subjects who fully understand the details of a clinical study and those who are cooperative, Subjects who were considered to be eligible for study participation until the end of the clinical study based on the investigator’s decision
Exclusion criteria
Exclusion criteria: * Patients who required fixation surgery and have 3 or more intervertebral discs * Patients who have previously undergone the spinal fusion surgery to be investigated in this clinical study, *or those who received interbody fusion using an anterior or posterior fixation technique * Patients diagnosed with osteoporosis (T-score =-2.5) * Patients with active systemic infection * Patients with infections on the fracture region, those with past medical history of pathologic fraction, and those with family history of metabolic bone disease (e.g., Paget disease, osteodystrophy, and heterotopic ossification) * Patients with uncontrolled hemorrhagic disease or inoperable disease * Patients with major mental diseases (e.g., schizophrenia, depression, bipolar disorder) considered ineligible for study participation based on the investigator’s decision * Patients with past history of hypersensitivity reaction to bone graft materials * Patients with abnormalities in blood test findings, or those who are suspected of hepatic and renal function degradation - Aspartate aminotransferase (AST) and Alanine transaminase (ALT) levels =2-fold the upper limit of the normal range (ULN) or - Blood urea nitrogen (BUN) and serum creatinine levels =1.5-fold the ULN * Those with medical history of known alcohol or drug abuse * Those with uncontrolled diabetes (fasting blood glucose levels >200 mg/dL) * Those with uncontrolled systemic diseases known to be likely to directly affect bone * fusion (e.g., hyperthyroidism, abnormalities in connective tissue metabolism, etc.) * Those with known human immunodeficiency virus (HIV) infections * Those with use of immunosuppressants * Those with a positive anti-rhBMP-2 antibody response * Those with use of corticosteroids (except for preparations for inhalation and external use) for at least 6 weeks within 12 months prior to the initiation of a clinical study Those with history of chemotherapy or radiotherapy for the treatment of cancer (except for skin basal cell cancer) Patients with known autoimmune disease (however, patients with lupus can participate in the clinical study.) * Those with the disease determined by the investigator to be unlikely to affect bone * Those who participated in a different clinical trial within 4 weeks prior to the study participation * Pregnant or lactating women * Those who did not consent to the use of acceptable contraceptive methods (e.g., sterilization operation, intrauterine device (IUD), and combination use of a diaphragm or condom with spermicide) during the period of this clinical study * Those who were determined by the investigator to be ineligible for participation in the clinical study because of other reasons
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Fusion rate at 24, 48 weeks after treatment, change in pain evaluated by 100 mm VAS (Visual Analog Scale) at 12, 24, 48 weeks after treatment, change in quality of life evaluated by Korean version ODI (Oswestry Disability Index) , Changes in quality of life evaluated by SF-36 (health questionnaire), presence of major adverse reactions (osteolysis, ectopic bone formation, malignant tumors) during the clinical trial. | — |
Primary
| Measure | Time frame |
|---|---|
| Fusion rate at 12-week time determined by CT evaluation and X-ray radiation evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactJUNGSOO LEE
Cellumed
Outcome results
None listed