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

NCT ID: NCT03358225

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-01

Brief Summary

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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

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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

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Cervical Spondylosis

Keywords

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Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anterior Cervical Discectomy and Fusion

The patients undergoing anterior cervical discectomy and fusion surgery

anterior cervical discectomy and fusion

Intervention Type PROCEDURE

The patients undergoing anterior cervical discectomy and fusion sugery

Cervical Artificial Disc Replacement

The patients undergoing cervical artificial disc replacement surgery

cervical artificial disc replacement

Intervention Type PROCEDURE

The patients undergoing cervical artificial disc replacement surgery

Hybrid surgery

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

hybrid surgery

Intervention Type PROCEDURE

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

Interventions

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anterior cervical discectomy and fusion

The patients undergoing anterior cervical discectomy and fusion sugery

Intervention Type PROCEDURE

cervical artificial disc replacement

The patients undergoing cervical artificial disc replacement surgery

Intervention Type PROCEDURE

hybrid surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Haiying

department of spinal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LIU Haiying

Role: PRINCIPAL_INVESTIGATOR

department of spinal surgery,PekingUPH

Central Contacts

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YU Guanjie, bachelor

Role: CONTACT

Phone: 18500234005

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24126076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24908252 (View on PubMed)

Toledano M, Bartleson JD. Cervical spondylotic myelopathy. Neurol Clin. 2013 Feb;31(1):287-305. doi: 10.1016/j.ncl.2012.09.003.

Reference Type BACKGROUND
PMID: 23186905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22754419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21289581 (View on PubMed)

Other Identifiers

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Hybrid007

Identifier Type: -

Identifier Source: org_study_id