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

NCT ID: NCT04559672

Last Updated: 2022-05-05

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myelopathy Cervical

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Laminoplasty Group

Patients who underwent cervical laminoplasty surgery due to myelopathy.

Cervical laminoplasty surgery

Intervention Type PROCEDURE

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

Laminectomy and Fusion Group

Patients who underwent cervical laminectomy and fusion surgery due to myelopathy.

Cervical laminectomy and fusion surgery

Intervention Type PROCEDURE

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

Interventions

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Cervical laminoplasty surgery

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

Intervention Type PROCEDURE

Cervical laminectomy and fusion surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xuhua Lu

Director of Traumatic Orthopaedic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuhua Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospotal

Locations

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Shanghai Changzheng Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuhua Lu, M.D.

Role: CONTACT

+862181885793

Bangke Zhang, M.D.

Role: CONTACT

+8618301783716

Facility Contacts

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Xiaoguang Li, M.D.

Role: primary

86-21-81885045

Other Identifiers

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CZ2020091101

Identifier Type: -

Identifier Source: org_study_id

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