NCT05602714

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

12.9 years

First QC Date

October 17, 2022

Last Update Submit

October 30, 2022

Conditions

Cervical Disc Degeneration

Keywords

Cervical Degenerative DiseaseCervical MyelopathyCervical RadiculopathyAnterior Cervical Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Neck Disability Index

    1st year

Interventions

Collection DataOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cervical degenerative disc disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Bingxuan Dr. Wu, PhD

CONTACT

+8615210063292bingxuanwoo@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 2, 2022

Study Start

January 1, 2012

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)