Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Conditions
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Arthrodesis

Intervention / Treatment
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* Device: ultrasonic osteotome
* Device: drill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL; aged more than 20 years 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasonic osteotome<br>making gutter on the hinge side of lamina with ultrasonic osteotome | Device: ultrasonic osteotome<br>* making gutter with ultrasonic osteotome<br>* Other names: misonix;|
| Sham Comparator: Drill<br>making gutter on the hinge side of lamina with conventional drill | Device: drill<br>* making gutter with drill<br>* Other names: electronic drill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone fusion rate | bony continuity on both ventral and dorsal laminaa | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding amount | bleeding amount through suction and gauze | during operation | 
| fracture of laminar | the number of fractured lamina per patient | during operation | 
| neck pain/arm pain | Visual analogue scale | postop 1 year | 
| Functional outcome | Neck disability index | postop 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthrodesiss, cervical vertebra, laminoplasty