Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT02487901
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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Notify Me20 year–100 year
All sexes
Interventional
Not applicable
Seoul, 110-744, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
making gutter with ultrasonic osteotome
Other names: misonix
making gutter with drill
Other names: electronic drill
Time frame: 6 months
Bone fusion based on computed tomography scan taken at postoperative 6 months
Time frame: during operation
bleeding amount through suction and gauze, unit mL
Time frame: during operation
The number of patients with lamina fractures.
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.
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.
Seoul National University Hospital
Other
Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Acronym: SONO
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View the official ClinicalTrials.gov record (opens in a new tab)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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