Trial Outcomes & Findings for Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome (NCT NCT02487901)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

190 participants

Primary outcome timeframe

6 months

Results posted on

2025-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasonic Osteotome making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Overall Study STARTED	95	95
Overall Study COMPLETED	95	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasonic Osteotome n=95 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=95 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill	Total n=190 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 12 • n=5 Participants	58 years STANDARD_DEVIATION 12 • n=7 Participants	58 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants	95 Participants n=7 Participants	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Korea	95 Participants n=5 Participants	95 Participants n=7 Participants	190 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Ultrasonic Osteotome n=95 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=95 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Number of Participants With Bone Fusion	43 Participants	60 Participants

SECONDARY outcome

Timeframe: during operation

Population: bleeding amount through suction and gauze Date from all participants in this study

bleeding amount through suction and gauze, unit mL

Outcome measures

Outcome measures
Measure	Ultrasonic Osteotome n=95 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=95 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Bleeding Amount	159.6 ml Standard Deviation 155.9	227.4 ml Standard Deviation 139.5

SECONDARY outcome

Timeframe: during operation

The number of patients with lamina fractures.

Outcome measures

Outcome measures
Measure	Ultrasonic Osteotome n=95 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=95 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Fracture of Laminar	23 Participants	25 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasonic Osteotome n=78 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=75 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Neck Pain/Arm Pain Neck pain	2.15 score on a scale Standard Deviation 0.25	1.96 score on a scale Standard Deviation 0.25
Neck Pain/Arm Pain Arm pain	3.02 score on a scale Standard Deviation 0.29	2.39 score on a scale Standard Deviation 0.30

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasonic Osteotome n=78 Participants making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome	Drill n=75 Participants making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill
Functional Outcome	11.30 percentage score on a 0-100% scale Standard Deviation 0.95	10.79 percentage score on a 0-100% scale Standard Deviation 0.97

Adverse Events

Ultrasonic Osteotome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chun Kee Chung

Seoul National Unversity College of Medicine

Phone: +82-2-2072-2357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place