Evaluation of Bone Union Following Anterior Cervical Fusion Using a PEEK Cage with a Surface Treated with Hydroxyapatite (Mightmus-HA™) Filled with Demineralized Bone Matrix (Bongener™): Comparison with a PEEK Cage Filled with a Mixture of Hydroxyapatite and ß-Tricalcium Phosphate (Cervios ChronOs™)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002001

Enrollment

Registered

2016-08-12

Start date

2016-08-02

Completion date

Unknown

Last updated

2019-03-11

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 : One of cages will be used in ACDF after radomization procedure - Experimental group: Polyetheretherketone (PEEK) Cage with a Surface Treated with Hydroxyapatite, filled with Demineral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age between 20 and 80 years, both genders 2) The patient who is expected to receive anterior cervical discectomy and fusion operation 3) Volunteer for this study with written consent

Exclusion criteria

Exclusion criteria: 1) Patient with cervical spine fracture, infection and malignant tumor 2) Below -3.5 T-score by DEXA(Dual X-ray Absorptiometry) bone densitometry 3) Patient who is not suitable for this study judged by principal investigator

Design outcomes

Primary

Measure	Time frame
Bone fusion	—

Secondary

Measure	Time frame
VAS of Neck Pain and Radiation pain	—

Countries

Korea, Republic of

Contacts

Public ContactJin S. Yeom

Seoul National University Bundang Hospital

highcervical@gmail.com

Outcome results