NCT02487901: SONO

Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Completed NA Results posted Last updated 27 March 2025

What this trial tests

NA trial testing ultrasonic osteotome in Arthrodesis in 190 participants. Completed in 4 February 2018.

Timeline

2 June 2015

Primary endpoint
4 February 2018

4 February 2018

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	190
Start date	2 June 2015
Primary completion	4 February 2018
Estimated completion	4 February 2018
Sites	1 location across South Korea

Drugs / interventions tested

• ultrasonic osteotome
• drill

Conditions studied

• Arthrodesis — all drugs for Arthrodesis →

Sponsor

Seoul National University Hospital

Who can join

Adults 20 to 100, any sex, with Arthrodesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Bone Fusion Primary · 6 months

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

Group	Value	95% CI
Ultrasonic Osteotome	43
Drill	60

Bleeding Amount Secondary · during operation

bleeding amount through suction and gauze, unit mL

Group	Value	95% CI
Ultrasonic Osteotome	159.6	± 155.9
Drill	227.4	± 139.5

Fracture of Laminar Secondary · during operation

The number of patients with lamina fractures.

Group	Value	95% CI
Ultrasonic Osteotome	23
Drill	25

Neck Pain/Arm Pain Secondary · 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.

Neck pain

Group	Value	95% CI
Ultrasonic Osteotome	2.15	± 0.25
Drill	1.96	± 0.25

Arm pain

Group	Value	95% CI
Ultrasonic Osteotome	3.02	± 0.29
Drill	2.39	± 0.30

Functional Outcome Secondary · 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. Thi

Group	Value	95% CI
Ultrasonic Osteotome	11.30	± 0.95
Drill	10.79	± 0.97

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Machine-learning-based models for the optimization of post-cervical spinal laminoplasty outpatient follow-up schedules.
   Seo Y, Jeong S, Lee S, Kim TS, et al · · 2024 · PMID 39350186 · DOI 10.1186/s12911-024-02693-y