A prospective study to assess the effectiveness of cage use in patients who need to interbody fusion surgery due to cervical disease

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1) adults aged 19 to 80
2) Patients with degenerative cervical disease in 1 level between C3 and T1 requiring Anterior cervical discectomy and fusion using the bioactive glass-ceramic cage.
a. Symptoms and signs radiating to one or both arms (e.g. pain, dysentery, or paralysis from the distribution of specific neurons) or related to acute or chronic spinal cord disease
b. Visual diagnosis of Cervical Herniation(Herniated) of Inter-Vertebral Disc and (or) bone formation (from C3-4 to C7- T1)
3) Willing to participate in clinical trials, treatment and obsevative procedures, and visit hospital

Exclusion Criteria

1) In the case of cervical pain without any uncertainty of radiated symptoms or spinal cord disease
2) Subject who has a history of interbody fusion in target site.
3) Subject with a history of malignant tumors (although the current condition has been cured and can be registered if it has not recurred in the last 5 years).
4) if pregnant or breastfeeding, or Subject with not agree to maintain contraception during clinical trial.
5) subject who have taken anticoagulant agent, steroids, and adrenal cortical hormones for a long period of time (e.g., those who have taken 10 mg per day on the Dexametasone for more than four weeks)
6) Subject with an uncorrected blood coagulation disorder (Platelet <50,000/ul, PT(INR)>2)
7) Subject with hypersensitivity BGS-7
8) Subject who is diagnosed with the following diseases and is deemed difficult to clinical trial:
f. Severe mental illness, epilepsy
g. Addictive narcotics and alcoholism of severe degree
h. Severe heart disease or liver dysfunction
i. Metabolic disease: osteomalacia, Paget disease
j. Inflammatory patients with relapse risk, blood patients
9) Other persons deemed inappropriate to participate in clinical trials by the investigator.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implant subsidence in X-ray

Secondary Outcome Measures

Name	Time	Method
implant subsidence in X-ray;implant migration in X-ray;Hardware failure in X-ray;Bone fusion in X-ray;Bone fusion in CT;Bone fusion area in CT;Change of VAS;Change of NDI(Neck Disability Index);Change of JOA(Japanese Orthopaedic Association);Change of SF-36;Satisfaction of investigator on the operation day