Completed

SONORandomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ultrasonic osteotome

+ drill

Device
Who is being recruted

Ankylosis

+ Joint Diseases

+ Musculoskeletal Diseases

From 20 to 100 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2015
See protocol details

Summary

Principal SponsorSeoul National University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 2, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
NCT02487901
Principal SponsorSeoul National University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnkylosisJoint DiseasesMusculoskeletal Diseases

Criteria

3 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
making gutter on the hinge side of lamina with ultrasonic osteotome

Group II

Sham
making gutter on the hinge side of lamina with conventional drill

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Seoul National University Hospital

Seoul, South KoreaOpen Seoul National University Hospital in Google Maps
CompletedOne Study Center