Clinical trial to evaluate the safety and efficacy of synthetic bone graft substitutes with growth factors for posterior lumbar interbody fusio

Not Applicable

Terminated

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0004738
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 19~79 years of age at the date of written informed consent
2. Patients requiring single- or double-level PLIF with pedicular fixation for the following reasons
1) Spinal Stenosis
2) Intervertebral disc disease
3) Spondylolysis or spondylolisthesis
4) Recurrent Lumbar Disc Herniation etc.
3. Signed and dated informed consent form

Exclusion Criteria

1. 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
2. Patients with a history of malignant tumors in the past 5 years
3. Those who have removed the tumor at graft site
4. Those who are undergoing anticancer therapy
5. Those who are diagnosed with the following disease
1) Mental illness
2) Drug intoxication and alcoholism
3) Liver cancer, liver cirrhosis
4) Acute/chronic infection
5) Acute/chronic renal failure
6) Elimination Disorders
7) Active Tuberculosis
8) Rickets, osteomalacia
9) Hypopituitarism, hyperpituitarism
10) Hypothyroidism, hyperthyroidism, hypoparathyroidism, hyperparathyroidism
11) Metabolic bone disease
6. Those who can’t stop taking antithrombotic or anticoagulant before surgery
7. Uncontrolled diabetes or hypertension or blood coagulation defect
8. Hypersensitivity to rhBMP-2, Beta-tricalciumphosphate
9. Previous surgical histroy on same level
10. Immune suppression or autoimmune disease
11. Vertebral body or disc infection on surgical site
12. Severe osteoporosis on DEXA bone density test (A T-score is -3.5 under)
13. Patients who have participated in other medical device clinical trials within six months (For clinical trials of drugs, within 30 days)
14. 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
Fusion rates of intervertebral

Secondary Outcome Measures

Name	Time	Method
Fusion rates of intervertebral;Rates of subsidence;Improvement compared to pre-operative VAS, ODI score