The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine

NCT ID: NCT02030899

Last Updated: 2024-04-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-01

Study Completion Date

2019-12-30

Brief Summary

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The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

Detailed Description

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cage: MC+® cage plate: atlantis® plate

Conditions

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Cervical Vertebrae Single Degenerative Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

ACDF with plate and autologous bone
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cage

Cage filled with autologous bone

Group Type ACTIVE_COMPARATOR

Cage fusion

Intervention Type PROCEDURE

Randomized selection of surgery type

Plate

Plate augmentation after iliac bone graft

Group Type OTHER

Plate fusion

Intervention Type PROCEDURE

Randomized selection of surgery type

Interventions

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Cage fusion

Randomized selection of surgery type

Intervention Type PROCEDURE

Plate fusion

Randomized selection of surgery type

Intervention Type PROCEDURE

Other Intervention Names

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Use of stand-alone Cage filled with autologous bone Use of Plate augmentation after autologous iliac bone graft

Eligibility Criteria

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Inclusion Criteria

* Single level degenerative cervical spine disease
* aged 30 - 70
* no improvement of symptom for 8 weeks of non-surgical treatment.
* degeneration in other levels without stenosis, accepted

Exclusion Criteria

* osteoporosis
* disease with poor bone quality
* Cancer
* Previous cervical spine surgery
* Multiple levels disease
* Ossification of posterior longitudinal ligament
* Kyphosis at the index level
* Developmental stenosis (diameter of C7 spinal canal \< 10mm)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun Kee Chung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CAP_2014

Identifier Type: -

Identifier Source: org_study_id

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