Cervical SpondylosisNCT03358225
A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis
An observational study of Cervical Spondylosis, run by Peking University People's Hospital.
Trial summary
A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Dec 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with bi-level cervical spondylosis
Who may be able to join
- (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.
Who cannot join
- ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.
Trial locations and contacts
No sites are listed yet.
About this study
A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.
Read the detailed description
Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.
- Conditions
- Cervical Spondylosis
- Being tested
- anterior cervical discectomy and fusion, cervical artificial disc replacement, hybrid surgery
- Keywords
- Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cervical discectomy and fusionProcedure or surgery
The patients undergoing anterior cervical discectomy and fusion sugery
cervical artificial disc replacementProcedure or surgery
The patients undergoing cervical artificial disc replacement surgery
hybrid surgeryProcedure or surgery
The patients undergoing 1-level C-ADR plus 1-level ACDF surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and Fusion | The patients undergoing anterior cervical discectomy and fusion surgery Receives: Procedure: anterior cervical discectomy and fusion | |
| Cervical Artificial Disc Replacement | The patients undergoing cervical artificial disc replacement surgery Receives: Procedure: cervical artificial disc replacement | |
| Hybrid surgery | The patients undergoing hybrid surgery(1-level ADR plus 1-level ACDF) surgery Receives: Procedure: hybrid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of the motion of operative segments and adjacent segments
Standard dynamic flexion and extension lateral cervical radiographs were obtained to evaluate range of motion of C2-C7 and operative segments and superior and inferior adjacent segments, cervical lordosis, and radiographic changes in adjacent segments.
Measured: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Secondary outcomes (3)
scores of the Japanese Orthopedic Association
Clinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)
Measured: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the Neck Disability Index
Clinical effects were evaluated based on scores of the Neck Disability Index(NDI)
Measured: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the visual analog scale
Clinical effects were evaluated based on scores of the visual analog scale(VAS)
Measured: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Haiying, Peking University People's Hospital
- Investigators
- LIU Haiying, Principal investigator, department of spinal surgery,PekingUPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358225
- Sponsor's protocol ID
- Hybrid007
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toledano M, Bartleson JD. Cervical spondylotic myelopathy. Neurol Clin. 2013 Feb;31(1):287-305. doi: 10.1016/j.ncl.2012.09.003.
PubMed 23186905Lebl DR, Hughes A, Cammisa FP Jr, O'Leary PF. Cervical spondylotic myelopathy: pathophysiology, clinical presentation, and treatment. HSS J. 2011 Jul;7(2):170-8. doi: 10.1007/s11420-011-9208-1. Epub 2011 Jun 22.
PubMed 22754419Veeravagu A, Cole T, Jiang B, Ratliff JK. Revision rates and complication incidence in single- and multilevel anterior cervical discectomy and fusion procedures: an administrative database study. Spine J. 2014 Jul 1;14(7):1125-31. doi: 10.1016/j.spinee.2013.07.474. Epub 2013 Oct 11.
PubMed 24126076Jia Z, Mo Z, Ding F, He Q, Fan Y, Ruan D. Hybrid surgery for multilevel cervical degenerative disc diseases: a systematic review of biomechanical and clinical evidence. Eur Spine J. 2014 Aug;23(8):1619-32. doi: 10.1007/s00586-014-3389-5. Epub 2014 Jun 8.
PubMed 24908252Lee MJ, Dumonski M, Phillips FM, Voronov LI, Renner SM, Carandang G, Havey RM, Patwardhan AG. Disc replacement adjacent to cervical fusion: a biomechanical comparison of hybrid construct versus two-level fusion. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1932-9. doi: 10.1097/BRS.0b013e3181fc1aff.
PubMed 21289581
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT03358225
- Acronym / sponsor ID
- Hybrid007
- Conditions
- Cervical Spondylosis
- Keywords
- Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 30 Nov 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.
A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.
Detailed description
Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion | – | Procedure: anterior cervical discectomy and fusionThe patients undergoing anterior cervical discectomy and fusion surgery |
| Cervical Artificial Disc Replacement | – | Procedure: cervical artificial disc replacementThe patients undergoing cervical artificial disc replacement surgery |
| Hybrid surgery | – | Procedure: hybrid surgeryThe patients undergoing hybrid surgery(1-level ADR plus 1-level ACDF) surgery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with bi-level cervical spondylosis
Key inclusion criteria (1 listed)
- (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.
Key exclusion criteria (1 listed)
- ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.
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 |
|---|---|---|
| anterior cervical discectomy and fusionThe patients undergoing anterior cervical discectomy and fusion sugery | Procedure or surgery | Anterior Cervical Discectomy and Fusion |
| cervical artificial disc replacementThe patients undergoing cervical artificial disc replacement surgery | Procedure or surgery | Cervical Artificial Disc Replacement |
| hybrid surgeryThe patients undergoing 1-level C-ADR plus 1-level ACDF surgery | Procedure or surgery | Hybrid surgery |
Primary outcome
range of the motion of operative segments and adjacent segments
Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Standard dynamic flexion and extension lateral cervical radiographs were obtained to evaluate range of motion of C2-C7 and operative segments and superior and inferior adjacent segments, cervical lordosis, and radiographic changes in adjacent segments.
3 secondary outcomes
scores of the Japanese Orthopedic Association
Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the Neck Disability Index
Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the visual analog scale
Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Background: PubMed 23186905Toledano M, Bartleson JD. Cervical spondylotic myelopathy. Neurol Clin. 2013 Feb;31(1):287-305. doi: 10.1016/j.ncl.2012.09.003.
- Background: PubMed 22754419Lebl DR, Hughes A, Cammisa FP Jr, O'Leary PF. Cervical spondylotic myelopathy: pathophysiology, clinical presentation, and treatment. HSS J. 2011 Jul;7(2):170-8. doi: 10.1007/s11420-011-9208-1. Epub 2011 Jun 22.
- Background: PubMed 24126076Veeravagu A, Cole T, Jiang B, Ratliff JK. Revision rates and complication incidence in single- and multilevel anterior cervical discectomy and fusion procedures: an administrative database study. Spine J. 2014 Jul 1;14(7):1125-31. doi: 10.1016/j.spinee.2013.07.474. Epub 2013 Oct 11.
- Background: PubMed 24908252Jia Z, Mo Z, Ding F, He Q, Fan Y, Ruan D. Hybrid surgery for multilevel cervical degenerative disc diseases: a systematic review of biomechanical and clinical evidence. Eur Spine J. 2014 Aug;23(8):1619-32. doi: 10.1007/s00586-014-3389-5. Epub 2014 Jun 8.
- Background: PubMed 21289581Lee MJ, Dumonski M, Phillips FM, Voronov LI, Renner SM, Carandang G, Havey RM, Patwardhan AG. Disc replacement adjacent to cervical fusion: a biomechanical comparison of hybrid construct versus two-level fusion. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1932-9. doi: 10.1097/BRS.0b013e3181fc1aff.
- 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.
LIU Haiying principal investigator
department of spinal surgery,PekingUPH
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis, 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 1 inclusion and 1 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 30 Nov 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 YU Guanjie, bachelor (18500234005, yuguanjieok@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of the motion of operative segments and adjacent segments (time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358225, which also lists 5 linked publications.
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 30 Nov 2017.