A Prospective, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used During the TLIF Procedure in Patients with Lumbar disc disease
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •* 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