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

Beijing Tiantan Hospital1,500 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Cervical Disc Degeneration

Interventions

Collection DataOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Japanese Orthopaedic Association Scale

Establishing 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.

Time frame: 1st year

Secondary Outcomes

Neck Disability Index

The 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.

Time frame: 1st year

Central Contacts

Bingxuan Dr. Wu, PhD

CONTACT

+8615210063292 bingxuanwoo@163.com

Data from ClinicalTrials.gov

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