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Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison

Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04559672
Enrollment
60
Registered
2020-09-23
Start date
2005-01-01
Completion date
2023-06-01
Last updated
2022-05-05

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

Conditions

Myelopathy Cervical

Brief summary

The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.

Interventions

PROCEDURECervical laminoplasty surgery

The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation

PROCEDURECervical laminectomy and fusion surgery

The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation

Sponsors

Shanghai Changzheng Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged at least 18 years * The patient has the diagnosis of degenerative cervical myelopathy * The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7 * More than five years of follow-up time

Exclusion criteria

* Presence of primary focal anterior compression of the cervical spinal cord * Previous surgery of the cervical spine * Tumor, infection, or trauma of the cervical spine or cord * Patients with ankylosing spondylitis * Patients with neurodegenerative diseases, or any neuropathies

Design outcomes

Primary

MeasureTime frameDescription
Change of Japanese Orthopaedic Association Score (JOA)baseline, 12 months post-treatment and through study completion, an average of 10 yearTotal score 0-17. The lower the score the more severe the deficits.
Change of Neck Disability Index (NDI)baseline, 12 months post-treatment and through study completion, an average of 10 yearRanging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Sagittal Lordosis Anglebaseline, 12 months post-treatment and through study completion, an average of 10 yearMeasured by lateral X-Ray image. The change of lordosis was calculated and compared.
Reoperation ratethrough study completion, an average of 10 yearAny reoperation involving the same segments or adjacent segments will be calculated.

Secondary

MeasureTime frameDescription
Change of Range of Motionbaseline, 12 months post-treatment and through study completion, an average of 10 yearMeasured by dynamic X-Ray image.
Complication ratethrough study completion, an average of 10 yearAny complications related to surgery will be recorded.
Change of Pain Scores on the Visual Analog Scale (VAS)baseline, 12 months post-treatment and through study completion, an average of 10 yearRanging from 0-10. A higher score indicates more severe pain.

Countries

China

Contacts

Primary ContactXuhua Lu, M.D.
xuhualu@hotmail.com+862181885793
Backup ContactBangke Zhang, M.D.
zbk12345@163.com+8618301783716

Outcome results

None listed

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