Skip to content

An interventional exploratory study on the clinical efficacy of anterior cervical discectomy and fusion with ß-tricalcium phosphate (ß-TCP) containing fusion cage

An interventional exploratory study on the clinical efficacy of anterior cervical discectomy and fusion with ß-tricalcium phosphate (ß-TCP) containing fusion cage

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094448
Enrollment
Unknown
Registered
2024-12-23
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

cervical spondylosis

Interventions

The group utilizing ß-TCP containing fusion cages:Receive ß-TCP containing fusion cages

Sponsors

Peking University Third Hospital; South China University of Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 70 years who meet the following criteria, have signed an informed consent form and are candidates for ACDF surgery: 1. Cervical spondylotic myelopathy or radiculopathy with anterior compression; 2. Cervical spinal stenosis accompanied by degenerative kyphosis.

Exclusion criteria

Exclusion criteria: 1. History of previous cervical spine surgery; 2. Severe osteoporosis (with a T-score 30); 4. Individuals with psychiatric or neurological disorders; 5. Individuals with liver, kidney, or hematological diseases and abnormal laboratory test results; 6. Individuals with poor compliance; 7. Individuals with other surgical contraindications; 8. Drug abusers or alcoholics; 9. Individuals who have participated in other clinical trials within the past 3 months; 10. Individuals with cervical spine trauma, infection, or neoplasia.

Design outcomes

Primary

MeasureTime frame
Bony Fusion Grade (CT);Bony Fusion Grade (X-Ray);

Secondary

MeasureTime frame
Implant subsidence value;Neck disability;Spinal cord function disability;Neck pain;Arm pain;Quality of life;Cervical spine C2-C7 range of motion;Cervical spine C2-7 sagittal vertical axis;Cervical spine C2-7 Cobb angle;Thoracic spine T1 slope;

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