None listed
Conditions
Interventions
Medical Device : A hydroxyapatite surface-treated PEEK cage is implanted once (1ea) at the anterior cervical lesion
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 19 years or older but under 75 years 2) Individuals with cervical myelopathy or radiculopathy involving one or two segments who have undergone conservative treatment for more than 3 months without improvement and are being considered for surgical treatment (exceptions may apply for cases of rapidly progressing neurological symptoms without a conservative treatment period) 3) Individuals scheduled to undergo anterior cervical discectomy and fusion (ACDF) involving one or two segments 4) Individuals who fully understand the purpose of the study and have provided voluntary consent
Exclusion criteria
Exclusion criteria: 1) Individuals with fractures or acute infections 2) Individuals who have undergone surgery on the relevant cervical spine segment 3) Individuals with bleeding disorders 4) Individuals with malignant tumors or a history of malignant tumors 5) Pregnant or breastfeeding individuals 6) Individuals unable to read or understand the consent form (e.g., illiterate individuals, foreigners, individuals with intellectual disabilities, or dementia patients) 7) Individuals deemed unsuitable for participation in this clinical trial by the principal investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteointeration | — |
Secondary
| Measure | Time frame |
|---|---|
| Subsidence | — |
Countries
Korea, Republic of
Contacts
Public ContactDongho Lee
Asan Medical Center
Outcome results
None listed