KCT0004738
Terminated
未知
Clinical trial to evaluate the safety and efficacy of NOVOSIS INJECT for posterior instrumentation & posterior lumbar interbody fusion; A single site, prospective, investigator initiated trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 20
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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