Evaluation of efficacy and safety of NOVOSIS, BONGROS, EXCELOS INJECT on the patient who underwent in Oblique lumbar interbody fusion to treat Degenerative Spinal Disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005328
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Over 20 years old
2) A patient who needs Oblique lumbar interbody fusion in 1 level or 2 ~ 3 levels between L2 ~ S1 due to one of the following degenerative lumbar diseases
? Spinal canal stenosis
? Herniation of intervertebral disc
? spondylolisthesis or spondylolysis
3) Those who are willing to participate in the trial, follow treatment and procedures, and visit the hospital for evaluation of all observations
4) A person who has voluntarily signed a written consent after hearing the purpose and method of this clinical trial.
1)1) Patients with severe osteoporosis (e.g., those with osteoporosis with an average T-score <-4.0 of the lumbar spine L1 to L4, or Z-score <-3.0 with osteoporosis in young women) on the DEXA)
2) Fracture of the application site (osteoporoticvertebral fracture, spine trauma fracture), acutely infected subjects, patients with hemorrhagic disease, patients with bone formation disorder
3) Those who have a history of fusion at the application site
4) A person with a history of malignancy (can be registered if the disease has been cured and has not relapsed in the past 5 years)
5) Patients with hypersensitivity to HA, ß-TCP, rhBMP-2
6) Those who are pregnant or lactating, who are planning to become pregnant during this trial or who do not agree with medically acceptable contraception.
7) Those who are diagnosed with the following diseases and are judged to have difficulty in surgery
? Uncontrolled diabetes, high blood pressure
? Mental illness: When conducting or complying with clinical trials is difficult
? Drug and alcohol addiction
? liver disease: liver cancer, cirrhosis, acute/chronic hepatitis
? Kidney disease: acute/chronic renal failure, impaired excretory function
? Heart disease: severe heart failure
? respiratory diseases: active tuberculosis
? Infectious diseases: active systemic infection and application site infection
? Metabolic diseases: rickets, osteomalacia, Paget's disease, pituitary dysfunction, (secondary) thyroid dysfunction, and other bone metabolic disorders
8) People who have long-term steroids, anticoagulants, etc.
9) Long-term use of anticoagulants
11) Persons who cannot prohibit drugs that may affect bone metabolism during the prohibition period
12) A terminal patient
13) Those who cannot understand the purpose and method of the clinical trial
14) Those who participated in another medical device intervention clinical trial within 6 months before participating in this study (for drug intervention clinical trials, those who participated within 30 days)
15) Subjects deemed difficult to conduct this clinical trial at the judgment of the responsible investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportions of subjects who achieved Bone fusion through Computed tomography (CT) for 52 weeks after treatment.
- Secondary Outcome Measures
Name Time Method Proportions of subjects who achieved Bone fusion through Radiographs at 4, 12, 24 and 52 weeks after treatment.;Changes from baseline in Visual Analogue Scale (VAS) at 24 and 52 weeks after treatment.;Changes from baseline in Oswestry disability index(ODI) at 24 and 52 weeks after treatment.