Cervical Disc DegenerationACCSSNCT05602714
Real World Data Collection and Analysis on the Anterior Cervical Spine Surgery
An observational study of Cervical Disc Degeneration, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Disc Degeneration
- What is being tested?
- Collection Data
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical degenerative disc disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Bingxuan Wu, PhD, +8615210063292, bingxuanwoo@163.com
About this study
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
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
- Conditions
- Cervical Disc Degeneration
- Being tested
- Collection Data
- Keywords
- Cervical Degenerative Disease, Cervical Myelopathy, Cervical Radiculopathy, Anterior Cervical Spine Surgery
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection DataOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Jan 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DegenerationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602714
- Sponsor's protocol ID
- KY201402502
- Acronym
- ACCSS
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05602714
- Acronym / sponsor ID
- ACCSS / KY201402502
- Conditions
- Cervical Disc Degeneration
- Keywords
- Cervical Degenerative Disease, Cervical Myelopathy, Cervical Radiculopathy, Anterior Cervical Spine Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical degenerative disc disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection Data | Other | – |
Primary outcome
Japanese Orthopaedic Association Scale
Time frame: 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.
1 secondary outcome
Neck Disability Index
Time frame: 1st year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Degeneration, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingxuan Dr. Wu, PhD (+8615210063292, bingxuanwoo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Japanese Orthopaedic Association Scale (time frame: 1st year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.