N/A
N=190
Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Arthrodesis
Bottom Line
View on ClinicalTrials.gov: NCT02487901 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Bone Fusion — 43; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ultrasonic osteotome (Device); drill (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Bone Fusion |
43; 60 | — |
| SECONDARY Bleeding Amount |
159.6; 227.4 | — |
| SECONDARY Fracture of Laminar |
23; 25 | — |
| SECONDARY Neck Pain/Arm Pain |
2.15; 1.96; 3.02; 2.39 | — |
| SECONDARY Functional Outcome |
11.30; 10.79 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02487901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.