None listed
Conditions
Interventions
Medical Device : Experiment group: Novomax Fusion Cage™ + Autograft bone 100%
Control group 1 : Novomax Fusion Cage™ + Autograft bone:BONION (5:5)
Control group 2 : Novomax Fusion Cage™ + BONION 100%
Sponsors
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 19 ~ 80 years old 2) The application of bioactive crystallized glass cage products to the multi-segment between C3 and T1 is required. Patients with degenerative cervical disease who require anterior cervical disc removal and fusion are associated with the following clinical signs and symptoms: a. Symptoms and signs radiating to one or both arms (pain, paresthesia, or paralysis depending on the distribution of specific nerve roots) or symptoms and signs related to acute or chronic myelopathy b. Imaging diagnosis of cervical disc herniation and/or osteophyte formation associated with clinical symptoms and signs of a. (C3-C4 to C7-T1) 3) Subjects willing to participate in clinical trials, comply with treatments and procedures, and visit hospital for all observational evaluations 4) Subjects who voluntarily signed the written consent after hearing the explanation of the purpose and method of this clinical trial 5) Subjects undergoing surgery using bioactive crystallized glass cage (Novomax Fusion Cage) in cervical disc removal and fusion
Exclusion criteria
Exclusion criteria: 1) Subjects with only cervical pain with uncertain or no radiating symptoms or myelopathy 2) Subjects with osteoporosis with an average hip joint T-score less than -3.5 on the DEXA bone density test 3) Subjects with a history of interbody fusion at the site to be evaluated 4) Subjects who have already had the same procedure in another segment of the cervical spine 5) Subjects who are pregnant or lactating, or those of childbearing age who do not agree to maintain contraception during the clinical period 6) Subjects who have taken anticoagulants, steroids, or corticosteroids for a long period of time (e.g., 10 mg of Dexametasone per day for 4 weeks or more) 7) Subjects with uncorrected blood coagulation disorders (Platelet2) 8) Subjects with a history of hypersensitivity to BGS-7 9) Subjects who are judged to be difficult to progress because they have been diagnosed with the following diseases: a. Severe mental illness, epilepsy b. History of malignancy (However, subjects who have been cured and have not recurred in the past 5 years can participate) c. Narcotic drugs and severe alcoholism d. Severe heart disease or liver dysfunction e. Metabolic diseases: osteomalacia, Paget's disease f. Risk of recurrence Patients with infectious diseases, patients with blood diseases 10) Subjects judged to be inappropriate to participate in clinical trials by other investigators: a. Those who cannot read or understand the consent form (illiterate, foreigner, mentally retarded) b. Those who are judged to be difficult to conduct this clinical trial due to the judgment of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All post-treatment adverse events (AEs), serious adverse events (SAEs), and unexpected adverse events (UAEs) related to clinical trial treatment;Bone union rate (%) on dynamic radiographs (X-ray) taken 48 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone union rate (%) on 3D CT scan (thin cut, 1mm interval) taken 48 weeks after surgery;Sedimentation rate (%) on CT scan taken 48 weeks after surgery;VAS (Visual Analogue Scale) change rate (%) for neck and upper extremity pain before and after 48 weeks of application of clinical trial medical device;Change rate (%) of Korean Neck Disability Index (KNDI) before and 48 weeks after application of clinical trial medical device | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Woo Hur
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed