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Implant-interface contact and implant stability in anterior cervical surgery: a prospective cohort study

A prospective cohort study using CBCT to investigate the effect of implant-bone interfacial space morphology on implant stability in anterior cervical surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091999
Enrollment
Unknown
Registered
2024-11-07
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Cervical spondylosis

Interventions

The segment with well-contacted implant-bone interface:None
The segment with less-contacted implant-bone interface:None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Patients with a confirmed diagnosis of cervical spondylotic radiculopathy or myelopathy based on clinical symptoms, physical signs, and imaging findings; 3. After standardized conservative treatment, the symptoms are ineffective or gradually aggravated, which affects daily life and work and requires anterior decompression surgery; 4. The surgical segment is between C3~C7, and surgery type is single or multilevel fusion or artificial disc replacement or hybrid surgery; 5. Be able to fully abide by this agreement psychologically and physically, and cooperate with the scheduled treatment plan and fill in the form, and cooperate with the follow-up; 6. After the informed consent is signed by the patient, it means that the patient already knows and agrees to carry out the relevant aspects of this study. The above standards are international standards, which are reasonable and feasible.

Exclusion criteria

Exclusion criteria: 1. Previous history of cervical spine surgery; 2. Spinal fracture, severe osteoporosis or a history of bone metabolic disease; 3. Local infection and ulceration of neck skin, systemic inflammatory diseases, uncontrolled diabetes, malignant tumors, active hepatitis, etc.; 4. People with severe mental illness or mental disorder; 5. The general condition is poor, and the vital organs suffer from serious diseases and cannot tolerate surgery; 6. Known to have infectious diseases such as AIDS, syphilis, etc.; 7. Suffering from autoimmune diseases; 8. Received daily immunosuppressant therapy for more than 1 month in the past 12 months; 9. Allergy to implant materials (PEEK or titanium alloy); 10. Severe obesity, history of drug abuse; 11. Those who are pregnant or have a pregnancy plan during the study; 12. Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Subsidence distance;

Secondary

MeasureTime frame
Subsidence rate;Fusion rate;Visual Analog Score;Therapeutic Index of the Japanese Orthopaedic Association;NDI score;Other imaging parameters;

Countries

China

Contacts

Public ContactWang Beiyu

West China Hospital, Sichuan University

dove-baker@163.com+86 184 8228 3583

Outcome results

None listed

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