Clinical evaluation of the efficacy and safety of RAFUGENTM BMP2 after Transforamenal Lumbar Interbody Fusion surgery
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005412
- Lead Sponsor
- Cellumed
- Brief Summary
A total of 76 subjects were screened and then enrolled in this clinical study. The number of subjects randomized into each group was 40 for the experimental group and 36 for the control group. All randomized subjects underwent TLIF, but 10 subjects (Experimental group: n=7, Control group: n=3) dropped out of the study during the entire period of clinical study. The number of subjects completed the clinical study was 66 in total (Experimental group: n=33, Control group: n=33). The fusion rate at 12 weeks post-treatment was 73.68% (28/38) for the experimental group and 58.82% (20/34) for the control group and was higher in the experimental group than in the control group. However, there were no statistically significant differences between groups in the fusion rate at 12 weeks post-treatment (p=0.1817). The fusion rates at 24 and 48 weeks post-treatment were 72.22% (26/36) and 82.86% (29/35), respectively, for the experimental group and 78.79% (26/33) and 78.13% (25/32), respectively, for the control group. There were no statistically significant differences between groups in the fusion rates at both 24 and 48 weeks post-treatment (p=0.5272, p=0.6247). The incidence rate of ADEs and SADEs reported during this clinical study was 15.00% (6/40) and 5.00% (2/40) each for the experimental group and 22.86% (8/35) and 8.57% (3/35) each for the control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
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
* 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fusion rate at 12-week time determined by CT evaluation and X-ray <br>radiation evaluation
- Secondary Outcome Measures
Name Time Method Fusion rate at 24, 48 weeks after treatment, change in pain <br>evaluated by 100 mm VAS (Visual Analog Scale) at 12, 24, 48 weeks after <br>treatment, change in quality of life evaluated by Korean version ODI (Oswestry <br>Disability Index) , Changes in quality of life evaluated by SF-36 (health <br>questionnaire), presence of major adverse reactions (osteolysis, ectopic bone <br>formation, malignant tumors) during the clinical trial.