Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Not Applicable

Completed

• Conditions: Arthrodesis
• Interventions: Device: drill; Device: ultrasonic osteotome

• Registration Number: NCT02487901
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06-02
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Primary Completion: 2018-02-04
• Study Completion: 2018-02-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drill	drill	making gutter on the hinge side of lamina with conventional drill
Ultrasonic osteotome	ultrasonic osteotome	making gutter on the hinge side of lamina with ultrasonic osteotome

Primary Outcome Measures

Name	Time	Method
bone fusion rate	6 months	bony continuity on both ventral and dorsal laminaa

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of