Comparative study of clinical and radiological outcomes of anterior cervical discectomy and fusion using ceramic cage or allograft spacer: a prospective randomized controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006577

Enrollment

Registered

2021-09-14

Start date

2021-10-11

Completion date

Unknown

Last updated

2023-08-21

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 : In this study, the efficacy of allograft material and ceramic cage in patients who underwent anterior cervical discectomy and fusion is evaluated by analyzing the difference between t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Symptoms and signs radiating to one or both arms (Pain, abnormality, or paralysis depending on the distribution of a particular neuromuscular muscle) or symptoms and signs related to acute or chronic myelopathy ? Conservative treatment (physical therapy, analgesic) for at least 8 weeks ? When it is possible to make an imaging diagnosis of one- or two-segment cervical disc herniation and osteophyte formation (from C3 to T1) associated with clinical symptoms and signs ? If you can and would like to participate in a clinical study ? With prior written consent of the patient or the patient's legal representative

Exclusion criteria

Exclusion criteria: ?In case of uncertain or ambiguous symptoms ?Previous history of anterior or posterior cervical surgery ?When there is a risk of instability due to a height difference of 3 mm or more in the simple radiography of extension and flexion ?If the segment has severe kyphosis (more than 7 degrees) ?If the patient fails to take an MRI ?If there is only cervical pain without radiating symptoms or myelopathy ?If you have an infection ?If you have a metabolic disease or bone disease such as severe osteoporosis ?If there is a tumor or trauma of the cervical spine ?If there is a deformity in the spine ?Severe mental illness

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale(VAS) score changes, NDI	—

Secondary

Measure	Time frame
Radiological evaluation;WBC, Segmented neutrophil count, ESR, CRP;Pathologic reflex, Spurling sign, Lheimitte sign	—

Countries

Korea, Republic of

Contacts

Public ContactCho-rong Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

chorong1984@gmail.com+82-2-2258-6844

Outcome results