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Status unknownNCT03358225Updated Nov 30, 2017

A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis

An observational study in Cervical Spondylosis, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-30.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
198
Ages
40 Years to 80 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Cervical Spondylosis

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Keywords

  • Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis
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In context

Spondylosis

142 studies on the registry are indexed under Spondylosis; 41 are open to participants now.

This study's planned enrollment of 198 is above the median of 100 across 36 observational studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.

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

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Who can participate

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

Study population

patients with bi-level cervical spondylosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
198 participants (estimated)
Patient registry
No

Groups and cohorts

  • Anterior Cervical Discectomy and Fusion

    The patients undergoing anterior cervical discectomy and fusion surgery

    Procedure: anterior cervical discectomy and fusion

  • Cervical Artificial Disc Replacement

    The patients undergoing cervical artificial disc replacement surgery

    Procedure: cervical artificial disc replacement

  • Hybrid surgery

    The patients undergoing hybrid surgery(1-level ADR plus 1-level ACDF) surgery

    Procedure: hybrid surgery

Interventions

  • Procedureanterior cervical discectomy and fusion

    The patients undergoing anterior cervical discectomy and fusion sugery

  • Procedurecervical artificial disc replacement

    The patients undergoing cervical artificial disc replacement surgery

  • Procedurehybrid surgery

    The patients undergoing 1-level C-ADR plus 1-level ACDF surgery

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Secondary outcomes

  1. scores of the Japanese Orthopedic Association

    Clinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)

    Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

  2. scores of the Neck Disability Index

    Clinical effects were evaluated based on scores of the Neck Disability Index(NDI)

    Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

  3. scores of the visual analog scale

    Clinical effects were evaluated based on scores of the visual analog scale(VAS)

    Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

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Study locations

No study locations are listed for this record.

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References and documents

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 23186905 ↗
  • Lebl 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 22754419 ↗
  • Veeravagu 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 24126076 ↗
  • Jia 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 24908252 ↗
  • Lee 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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2018; primary completion for Dec 2018, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2017
First posted
Nov 30, 2017
StartEst.
Jan 1, 2018
Primary completionEst.
Dec 1, 2018
CompletionEst.
Dec 1, 2018
Last update
Nov 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03358225
Responsible party
Liu Haiying (department of spinal surgery, Peking University People's Hospital) — Principal investigator
First posted
Nov 30, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Dec 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Nov 30, 2017

Study contacts

YU Guanjie, bachelor
Contact
yuguanjieok@163.com
18500234005
LIU Haiying
principal investigator · department of spinal surgery,PekingUPH

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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