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

Safety and Effectiveness Evaluation of Bioactive glass ceramic cage in Anterior Cervical Discectomy and Fusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005601

Enrollment

Registered

2020-11-13

Start date

2020-11-20

Completion date

Unknown

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : After identifying and cutting the target site, carefully perform the soft tissue incision to approach the target site, remove the intervertebral disc and trim the cartilage longitudin

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
implant subsidence in X-ray	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactDong-a shin

Yonsei University Health System, Severance Hospital

Outcome results