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A prospective randomized controlled clinical study on the effects of selective replacement of a single segment during consecutive two-segment anterior cervical spine surgery on surgical outcomes and cervical spine stability

A prospective randomized controlled clinical study on the effects of selective replacement of a single segment during consecutive two-segment anterior cervical spine surgery on surgical outcomes and cervical spine stability

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118266
Enrollment
Unknown
Registered
2026-02-03
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Cervical spondylosis requiring surgical intervention in consecutive two segments

Interventions

FA:Anterior Cervical Discectomy and Fusion + Artificial Cervical Disc Replacement
2F:Two-segment Anterior Cervical Discectomy and Fusion
AF:Artificial Cervical Disc Replacement + Anterior Cervical Discectomy and Fusion

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with clinically diagnosed, imaging-confirmed, consecutive two-segment cervical spondylosis; 2.Patients who have undergone standardized conservative treatment but have not responded or whose symptoms have progressively worsened, affecting their daily life and work, and who require intervertebral decompression surgery; 3.The surgical segments are two consecutive segments between C3/4 and C6/7; 4.Be able to fully abide by this agreement psychologically and physically, cooperate with the scheduled treatment plan, fill out forms, and cooperate with follow - up visits; 5.After the patient signs the informed consent, it means that the patient has been informed of and agrees to the implementation and conduct of the relevant aspects of this study;

Exclusion criteria

Exclusion criteria: 1.Patients with a history of cervical spine surgery or adjacent segmental osteoarthritis; 2.Patients with ossification of the posterior longitudinal ligament or cervical spinal stenosis, spinal fractures, severe osteoporosis, or a history of bone metabolic disorders; 3.Patients with obvious instability in the segment requiring surgery (Cobb angle change > 13° in the flexion-extension radiograph, or horizontal displacement of the upper and lower vertebrae > 3 mm); 4.Localized skin infections and ulcers in the neck area, systemic inflammatory diseases, rheumatoid arthritis, uncontrolled diabetes, malignant tumors, active hepatitis, etc. 5.Patients with mental illness or psychological disorders; 6.Patients with poor overall health conditions, severe diseases in vital organs, and inability to tolerate surgery; 7.Known to have infectious diseases such as AIDS, syphilis, etc. 8.Received immunosuppressive therapy daily for more than 1 month in the past 12 months; 9.Allergy to implant materials (PEEK or titanium alloy); 10.Patients with severe obesity or a history of drug abuse; 11.Pregnant women or those planning to become pregnant during the study period; 12.Participating in other studies that may affect the results of this study;

Design outcomes

Primary

MeasureTime frame
C2-7 Cobb angle;T1 slope;NDI score;sagittal vertical axis;ROM of adjacent segments;ROM of operated segments;

Secondary

MeasureTime frame
Postoperative complications;JOA score;VAS score;fusion rate of fusion segment;

Countries

China

Contacts

Public ContactLiu Hao

West China Hospital of Sichuan University

liuhao6304@126.com+86 528 8542 2573

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026