Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome (SONO)

Seoul National University

Status

Completed

Conditions

Arthrodesis

Treatments

Device: drill

Device: ultrasonic osteotome

Study type

Interventional

Funder types

Other

Identifiers

NCT02487901

SONO1

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

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