Cervical Disc DegenerationNCT03360409
Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph
A study testing ACD, ACDF and ACDA in people with Cervical Disc Degeneration, run by Peking University People's Hospital.
Trial summary
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cervical Disc Degeneration
- What is being tested?
- ACD, ACDF and ACDA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Jun 2020
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with arm pain not responding to conservative treatment
- lasted longer than 10 weeks
- single level disc degeneration
- mobile spine on dynamic lateral cervical X-rays
Who cannot join
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.
Read the detailed description
This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.
- Conditions
- Cervical Disc Degeneration
- Being tested
- ACD, ACDF, ACDA
- Keywords
- Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACDProcedure or surgery
Undertake anterior cervical discectomy without fusion
ACDFProcedure or surgery
anterior cervical discectomy with fusion
ACDAProcedure or surgery
anterior cervical discectomy with arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| grade 1 | Experimental | ACD Receives: Procedure: ACD |
| grade 2 | Active comparator | ACDF Receives: Procedure: ACDF |
| grade 3 | Active comparator | ACDA Receives: Procedure: ACDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cervical alignment
The Harrison posterior tangent method was used as an estimate for curvature
Measured: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
Secondary outcomes (1)
quality of life
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Measured: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jun 2020 (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 Peking University People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Zhenqi, Peking University People's Hospital
- Investigators
- zhenqi zhu, Study director, PekingUPH department of spinal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360409
- Sponsor's protocol ID
- CACD3
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 4 Dec 2017
- 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 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03360409
- Acronym / sponsor ID
- CACD3
- Conditions
- Cervical Disc Degeneration
- Keywords
- Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 4 Dec 2017 (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.
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.
Detailed description
This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| grade 1 | Experimental | Procedure: ACDACD |
| grade 2 | Active comparator | Procedure: ACDFACDF |
| grade 3 | Active comparator | Procedure: ACDAACDA |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with arm pain not responding to conservative treatment
- lasted longer than 10 weeks
- single level disc degeneration
- mobile spine on dynamic lateral cervical X-rays
Key exclusion criteria (5 listed)
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography
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 |
|---|---|---|
| ACDUndertake anterior cervical discectomy without fusion | Procedure or surgery | grade 1 |
| ACDFanterior cervical discectomy with fusion | Procedure or surgery | grade 2 |
| ACDAanterior cervical discectomy with arthroplasty | Procedure or surgery | grade 3 |
Primary outcome
change of cervical alignment
Time frame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
The Harrison posterior tangent method was used as an estimate for curvature
1 secondary outcome
quality of life
Time frame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- 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.
zhenqi zhu study director
PekingUPH department of spinal surgery
Questions about this trial
What is this clinical trial studying?
A study testing ACD, ACDF and ACDA in people with Cervical Disc Degeneration, run by Peking University People's Hospital.
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 4 inclusion and 5 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 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 chen guo (8618055644700, fantasy_g@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of cervical alignment (time frame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years). 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 4 Dec 2017; AzTrials last refreshed its copy on 2 Nov 2026.