Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Arthrodesis Clinical Trial

— SONO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487901
• Other study ID #: SONO1
• Status: Completed
• Phase: N/A
• Start date: June 2, 2015
• Est. completion date: February 4, 2018

Study information

• Verified date: February 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: February 4, 2018
• Est. primary completion date: February 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

1. cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;

2. aged more than 20 years

3. with American Society of Anesthesiology physical status class 1 or 2

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arthrodesis

Intervention

Device:
• ultrasonic osteotome
making gutter with ultrasonic osteotome
• drill
making gutter with drill

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone fusion rate	bony continuity on both ventral and dorsal laminaa	6 months
Secondary	bleeding amount	bleeding amount through suction and gauze	during operation
Secondary	fracture of laminar	the number of fractured lamina per patient	during operation
Secondary	neck pain/arm pain	Visual analogue scale	postop 1 year
Secondary	Functional outcome	Neck disability index	postop 1 year