Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusio
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0005610
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 154
1. 19~75 years of age at the date of written informed consent
2. Patients requiring one- or two-level laminectomy with fusion for the following reasons
(This clinical trial is performed for patients who do not respond despite 3 months of conservative treatment or who continue to have pain with a VAS score of 4 or higher.)
1) Spinal Stenosis
2) Severe herniated disc with neurologic deficit (such as cauda equina syndrome)
3) Spondylolysis or spondylolisthesis
4) Recurrent Lumbar Disc Herniation etc.
3. It able to comply with the study plan and can visit every follow-up for this study
4. It able to understand and sign the subject Informed Consent Form.
1. Prior interbody surgery at the same level
2. Pregnant or lactating women, or those who are planning pregnancy for the duration of this clinical trial or don't agree to medically accepted contraceptive methods
* Medically accepted contraceptive methods: condoms, oral contraceptives for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives, etc.
3. Severe osteoporosis on DEXA bone density test (DEXA T-score is -3.0 or lower)
4. Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 5 year
5. Hypersensitivity to rhBMP-2, Hydroxyapatite,PEEK.
6. Those who are diagnosed with the following disease.
1) Mental illness
2) Drug intoxication and alcoholism
3) liver disease; Liver cancer, cirrhosis, acute/chronic hepatitis4) Acute/chronic renal failure
4) kidney disease; Acute/chronic renal failure, Elimination disorders
5) heart disease; Severe heart failure
6) respiratory diseases; Active tuberculosis
7) infectious diseases; Active systemic infection and application site infection
8) metabolic diseases; Rickets, osteomalacia, pituitary dysfunction, thyroid dysfunction, and other bone metabolic disorders
9) fracture of the applied area; osteoporotic vertebral fracture, spine trauma fracture
7. Those who can’t prohibit drugs (parathyroid hormone, bisphosphonate, Systemic Steroid) that may affect bone metabolism during the prohibition period
8. Those who severe autoimmune disease
9. Those who smoke more than 20 per day
10. BMI > 35 kg/m2
11. Those who can’t stop taking antithrombotic or anticoagulant before surgery
12. Uncontrolled diabetes or hypertension or blood coagulation defect
13. terminal patient
14. Those who cannot understand the purpose and method of clinical trials
15. Patients who have participated in other medical device clinical trials within six months (For clinical trials of drugs, within 30 days)
16. Others, if judged by the investigator to be inappropriate for participation in this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone fusion rate on CT after surgery (%)
- Secondary Outcome Measures
Name Time Method Bone fusion rate on CT after surgery (%) : evaluation by surgical site(level);Serial ODI score changes after surgery;Serial EQ-5D score changes;Serial VAS score changes