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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03358225
Enrollment
198
Registered
2017-11-30
Start date
2018-01-01
Completion date
2018-12-01
Last updated
2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spondylosis

Keywords

Hybrid surgery,ACDF,C-ADR,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.

Interventions

The patients undergoing anterior cervical discectomy and fusion sugery

PROCEDUREcervical artificial disc replacement

The patients undergoing cervical artificial disc replacement surgery

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

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
range of the motion of operative segments and adjacent segmentspreoperatively, within 5 days after surgery, and at 6, and 12 months postoperativelyStandard 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.

Secondary

MeasureTime frameDescription
scores of the Japanese Orthopedic Associationpreoperatively, within 5 days after surgery, and at 6, and 12 months postoperativelyClinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)
scores of the Neck Disability Indexpreoperatively, within 5 days after surgery, and at 6, and 12 months postoperativelyClinical effects were evaluated based on scores of the Neck Disability Index(NDI)
scores of the visual analog scalepreoperatively, within 5 days after surgery, and at 6, and 12 months postoperativelyClinical effects were evaluated based on scores of the visual analog scale(VAS)

Contacts

Primary ContactYU Guanjie, bachelor
yuguanjieok@163.com18500234005

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026