Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Not Applicable

Completed

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.

Recruitment & Eligibility

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

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

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
Number of Participants With Bone Fusion	6 months	Bone fusion based on computed tomography scan taken at postoperative 6 months

Secondary Outcome Measures

Name	Time	Method
Bleeding Amount	during operation	bleeding amount through suction and gauze, unit mL
Fracture of Laminar	during operation	The number of patients with lamina fractures.
Neck Pain/Arm Pain	postop 1 year	Neck pain and arm pain were measured using a visual analogue scale (VAS), which is an integer with a minimum value of 0 and a maximum value of 10. Higher scores indicate a worse outcome.
Functional Outcome	postop 1 year	Functional outcomes were assessed using the Neck Disability Index (NDI). The NDI consists of the following 10 subscales, each scored on a scale from 0 to 5: Pain intensity (range: 0-5) Personal care (range: 0-5) Lifting (range: 0-5) Reading (range: 0-5) Headaches (range: 0-5) Concentration (range: 0-5) Work (range: 0-5) Driving (range: 0-5) Sleeping (range: 0-5) Recreation (range: 0-5) Each subscale has a minimum score of 0 and a maximum score of 5, with higher values indicating worse outcomes. The total NDI score is calculated as the sum of all 10 subscale scores, ranging from 0 to 50. This total score is then converted into a percentage score (0-100%) by dividing the total score by 50 and multiplying by 100. Higher percentage scores indicate worse functional outcomes.