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RecruitingNCT05602714ACCSSUpdated Nov 2, 2022

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

An observational study in Cervical Disc Degeneration, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2012; still recruiting 14 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Cervical Disc Degeneration

Keywords

  • Cervical Degenerative Disease
  • Cervical Myelopathy
  • Cervical Radiculopathy
  • Anterior Cervical Spine Surgery
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cervical degenerative disc disease

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • OtherCollection Data
06

What researchers measure

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.

    Time frame: 1st year

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05602714
Lead sponsor
Beijing Tiantan Hospital
Collaborators
National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Nov 2, 2022
Start date
Jan 1, 2012
Primary completion
Dec 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 2, 2022

Study contacts

Bingxuan Dr. Wu, PhD
Contact
bingxuanwoo@163.com
+8615210063292

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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