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

Recruiting

• Conditions: Cervical Disc Degeneration

• Registration Number: NCT05602714
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-30
• Last Update Submitted: 2022-10-30
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Japanese Orthopaedic Association Scale	1st year	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.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index	1st year	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China