None listed
Conditions
Interventions
Medical Device : Surgery is performed in the same way as anterior cervical discectomy and fusion (ACDF). Under general anesthesia, the operation is performed at the supine position with a slight exten
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 19 to 79 year-old. (19 ? Age < 80) 2. The following cervical disc disease and degenerative disease associated with the following clinical signs and symptoms require anterior cervical disc removal and fusion: a) Symptoms and signs of radiation to one or both arms (pain, abnormal sensation or paralysis due to the distribution of certain nerve roots) or signs or symptoms related to acute or chronic myelopathy. b) If there is an imaging diagnosis of cervical intervertebral disc herniation or/and bony scar formation(cervical spine 3-4 to cervical spine 7-thoracic spine 1) in one or both segments associated with clinical signs and symptoms of a) 3. A person who is willing to participate in the examination, and visit the hospital for all observation period. 4. A person who has voluntarily signed a written consent by hearing about the purpose and method of this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Symptom of radiating or myelopathy are uncertain and only cervical pain is present. 2. A person with a history of malignant tumors (if the disease has been cured and has not recurred in the past 5 years) 3. If patient is pregnant or lactating, or is a child of childbearing age, patient does not agree to maintain contraception for the duration of the trial. 4. Chronic taking steroids, corticosteroids (eg, those taking Dexamethasone 10 mg / day for more than 4 weeks) 5. Persons with history of hypersensitivity to BGS-7 and titanium. 6. Those who are diagnosed with the following diseases and considered to be difficult to proceed a. Spinal deformity b. Unregulated diabetes, hypertension c. Severe mental illness, epilepsy d. Drug abuse and severe alcoholic e. Severe heart disease or liver dysfunction f. Metabolic disorders: severe osteoporosis (mean T-score <-3.0 on DEXA bone mineral density), rickets, osteomalacia, pituitary dysfunction, (para-)thyroid dysfunction, limb compartment syndrome, g. Patient with infectious disease or blood disease who are at high risk of recurrence 7. Those who are deemed to have difficulty performing the clinical trial at the discretion of the examiners (such as those who can not perform the tests required in this study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of initial application success rate(%) of customized implant with plain radiograph | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of application success rate(%) of customized implant with plain radiograph at 1, 3, 6 months after operation;Evaluation of Investigator Application Satisfaction;All the adverse event that occurred to subjects after application of investigational medical devices | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Uk Kuh
Yonsei University
Outcome results
None listed