Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-02

Study Completion Date

2018-02-04

Brief Summary

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Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. In the present study, the investigators are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

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Detailed Description

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Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony fusion rate may be increased because of low thermal injury to the bone. In the present study, we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Conditions

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Arthrodesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

ultrasonic bone osteotome

Study Groups

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Ultrasonic osteotome

making gutter on the hinge side of lamina with ultrasonic osteotome

Group Type ACTIVE_COMPARATOR

ultrasonic osteotome

Intervention Type DEVICE

making gutter with ultrasonic osteotome

Drill

making gutter on the hinge side of lamina with conventional drill

Group Type SHAM_COMPARATOR

drill

Intervention Type DEVICE

making gutter with drill

Interventions

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ultrasonic osteotome

making gutter with ultrasonic osteotome

Intervention Type DEVICE

drill

making gutter with drill

Intervention Type DEVICE

Other Intervention Names

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misonix electronic drill

Eligibility Criteria

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Inclusion Criteria

1. cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;
2. aged more than 20 years
3. with American Society of Anesthesiology physical status class 1 or 2

Exclusion Criteria

1\) concomitant neurological disease such as cerebral palsy or amyotrophic lateral sclerosis; 2) concurrent cancer or infection; 3) previous cervical spinal surgery; 4) a trauma-associated lesion; 5) inability to be followed up (i.e., foreign patients); 6) refusal to participate in the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No