Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Seoul National University Hospital190 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Arthrodesis

Interventions

ultrasonic osteotomeDEVICE

making gutter with ultrasonic osteotome

drillDEVICE

making gutter with drill

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants With Bone Fusion

Bone fusion based on computed tomography scan taken at postoperative 6 months

Time frame: 6 months

Secondary Outcomes

Bleeding Amount

bleeding amount through suction and gauze, unit mL

Time frame: during operation

Fracture of Laminar

The number of patients with lamina fractures.

Time frame: during operation

Neck Pain/Arm Pain

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.

Time frame: postop 1 year

Functional Outcome

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.

Time frame: postop 1 year

Data from ClinicalTrials.gov

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