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

Cervical Disc Degeneration Clinical Trial

— ACCSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602714
• Other study ID #: KY201402502
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Beijing Tiantan Hospital
• Contact: Bingxuan Dr. Wu, PhD
• Phone: +8615210063292
• Email: bingxuanwoo[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Other:
• Collection Data

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1st year
Secondary	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.	1st year