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Augmented reality navigation under surgical microscope for anterior cervical surgery decompression by intervertebral space: an IDEAL stage 1 study

Augmented reality navigation under operating microscope for anterior cervical surgery decompression by intervertebral space: an IDEAL stage 1 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094844
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-31
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

surgical microscope augmented reality navigation for intervertebral decompression:surgical microscope augmented reality navigation for intervertebral decompression during anterior cervical surgery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 80; (2) Patients with radiculopathy or cervical spondylotic myelopathy diagnosed according to clinical symptoms, signs and imaging findings; (3) Patients with ineffective or progressive aggravating symptoms after standard conservative treatment, affecting daily life and work, and requiring anterior decompression surgery; (4) Single or multi-segment fusion surgery or artificial cervical disc replacement or Hybrid surgery with surgical segments between C3 and C7; (5) Be mentally and physically able to fully comply with the predetermined treatment plan and fill out forms, and cooperate with follow-up visits;

Exclusion criteria

Exclusion criteria: (1) Previous cervical spine surgery history, adjacent segment bone fusion; (2) spinal fracture, severe osteoporosis, or a history of bone metabolic disease; (3) Local infection and collapse of the neck skin, systemic inflammatory diseases, rheumatoid arthritis, uncontrolled diabetes, malignant tumors, active hepatitis, etc.; (4) Persons with serious mental illness or mental disorder; (5) poor condition of the whole body, serious diseases of important organs, can not tolerate surgery; (6) known to have infectious diseases such as AIDS, syphilis, etc.; (7) have received immunosuppressive therapy daily for more than 1 month in the past 12 months; (8) Allergic to implant materials or hemostatic materials; (9) Severe obesity, drug abuse history; (10) Pregnancy or pregnancy planning during the study; (11) Combined anterior and posterior surgery is required; (12) Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Surgery-related complication incidence rate;Fusion rate;

Secondary

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

Countries

China

Contacts

Public ContactWang Beiyu

West China Hospital, Sichuan University

hxiisha@163.com+86 186 4057 3266

Outcome results

None listed

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