Clinical trial NCT03358225: A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis
Official title: A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylosis
Keywords: Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 198
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with bi-level cervical spondylosis

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: range of the motion of operative segments and adjacent segments
timeFrame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Secondary outcomes:
measure: scores of the Japanese Orthopedic Association
timeFrame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
measure: scores of the Neck Disability Index
timeFrame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
measure: scores of the visual analog scale
timeFrame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: department of spinal surgery,PekingUPH
name: LIU Haiying
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toledano M, Bartleson JD. Cervical spondylotic myelopathy. Neurol Clin. 2013 Feb;31(1):287-305. doi: 10.1016/j.ncl.2012.09.003.
citation: 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.
citation: 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.
citation: 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.
citation: 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.