Skip to content

A Prospective Cohort Study on the Clinical Efficacy of Titanium Coated Zero-Profile Interbody Fusion Devices in Anterior Cervical Discectomy and Fusion

A Prospective Cohort Study on the Clinical Efficacy of Titanium Coated Zero-Profile Interbody Fusion Devices in Anterior Cervical Discectomy and Fusion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095987
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical spondylosis

Interventions

titanium-coated group:Patients who meet the inclusion and exclusion criteria of this study and undergo anterior cervical discectomy and fusion using titanium-coated zero-profile interbody fusion devic
pure-PEEK group:Patients who meet the inclusion and exclusion criteria of this study and undergo anterior cervical discectomy and fusion using zero-profile PEEK interbody fusion devices.

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 70 years, diagnosed with the following conditions, who are scheduled to undergo single-level ACDF and have signed an informed consent form: (1) cervical spondylotic myelopathy (2) cervical spondylotic radiculopathy (3) mixed cervical spondylosis (4) ossification of the posterior longitudinal ligament (OPLL) of the cervical spine (5) with or without mild cervical kyphosis (C2-7 Cobb angle < 10 degrees, kyphosis)

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions will be excluded from the study: History of previous cervical spine surgery Patients scheduled for multi-segment cervical spine surgery Severe osteoporosis (CT value of cervical vertebrae 30) Mental or neurological disorders Liver, kidney, or hematological diseases with abnormal laboratory results Poor compliance Other surgical contraindications Substance abuse or alcoholism Participation in other clinical trials within the last three months

Design outcomes

Primary

MeasureTime frame
Fusion status of surgical segment;Implant subsidence;

Secondary

MeasureTime frame
Cervical 3-7 range of motion (C3-7 ROM);Cervical 2-7 Cobb angle (C2-7 Cobb);Thoracic 1 Slope (T1 Slope);Cervical 2-7 sagittal vertical axis (C2-7 SVA);Neck pain;Cervical function;neurological function;Quality of life;

Countries

China

Contacts

Public ContactZhou Feifei

Peking University Third Hospital

orthozhou@163.com+86 135 8178 7350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026