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Completed

NCT Number: NCT02487901

Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

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.

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasonic osteotome

Device

making gutter with ultrasonic osteotome

Other names: misonix

drill

Device

making gutter with drill

Other names: electronic drill

Primary outcomes

  1. Number of Participants With Bone Fusion

    Time frame: 6 months

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

Secondary outcomes

  1. Bleeding Amount

    Time frame: during operation

    bleeding amount through suction and gauze, unit mL

  2. Fracture of Laminar

    Time frame: during operation

    The number of patients with lamina fractures.

  3. Neck Pain/Arm Pain

    Time frame: 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.

  4. Functional Outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: SONO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2015
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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