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Real World Data Collection and Analysis on the Anterior Cervical Spine Surgery

Efficacy and Safety of Anterior Cervical Spine Surgery in Patients With Cervical Degenerative Disc Disease - a Real World Data Collection and Analysis Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05602714
Acronym
ACCSS
Enrollment
1500
Registered
2022-11-02
Start date
2012-01-01
Completion date
2025-12-31
Last updated
2022-11-02

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

Conditions

Cervical Disc Degeneration

Keywords

Cervical Degenerative Disease, Cervical Myelopathy, Cervical Radiculopathy, Anterior Cervical Spine Surgery

Brief summary

This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Detailed description

This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Interventions

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Patients over 18 years old 2. Clinical symptoms and imaging support cervical degenerative disc disease; 3. Failed a minimum of 3months conservative treatment 4. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery 5. Written informed consent given by subject

Exclusion criteria

1. Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded 2. Patients with cervical spine X-ray film and CT scan contraindications 3. Women who are lactating and pregnant

Design outcomes

Primary

MeasureTime frameDescription
Japanese Orthopaedic Association Scale1st yearEstablishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. The minimum value is 0, and the maximum value is 17. Higher scores mean a better outcome.

Secondary

MeasureTime frameDescription
Neck Disability Index1st yearThe index to evaluate the neck pain and life quality. The minimum value is 0%, and the maximum value is 100%. Higher scores mean a worse outcome.

Countries

China

Contacts

Primary ContactBingxuan Dr. Wu, PhD
bingxuanwoo@163.com+8615210063292

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026