NCT02487901

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2018

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

June 26, 2015

Results QC Date

April 16, 2024

Last Update Submit

March 9, 2025

Conditions

Arthrodesis

Keywords

arthrodesisscervical vertebralaminoplasty

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Bone Fusion

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

    6 months

Secondary Outcomes (4)

  • Bleeding Amount

    during operation

  • Fracture of Laminar

    during operation

  • Neck Pain/Arm Pain

    postop 1 year

  • Functional Outcome

    postop 1 year

Study Arms (2)

Ultrasonic osteotome

ACTIVE COMPARATOR

making gutter on the hinge side of lamina with ultrasonic osteotome

Device: ultrasonic osteotome

Drill

SHAM COMPARATOR

making gutter on the hinge side of lamina with conventional drill

Device: drill

Interventions

ultrasonic osteotomeDEVICE

making gutter with ultrasonic osteotome

Also known as: misonix
Ultrasonic osteotome
drillDEVICE

making gutter with drill

Also known as: electronic drill
Drill

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Seo Y, Jeong S, Lee S, Kim TS, Kim JH, Chung CK, Lee CH, Rhee JM, Kong HJ, Kim CH. Machine-learning-based models for the optimization of post-cervical spinal laminoplasty outpatient follow-up schedules. BMC Med Inform Decis Mak. 2024 Sep 30;24(1):278. doi: 10.1186/s12911-024-02693-y.

    PMID: 39350186DERIVED

  • Kim CH, Chung CK, Choi Y, Kuo CC, Lee U, Yang SH, Lee CH, Jung JM, Hwang SH, Kim DH, Yoon JH, Paik S, Lee HJ, Jung S, Park SB, Kim KT, Park HP. The Efficacy of Ultrasonic Bone Scalpel for Unilateral Cervical Open-Door Laminoplasty: A Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):825-834. doi: 10.1093/neuros/nyz301.

    PMID: 31435653DERIVED

MeSH Terms

Conditions

Ankylosis

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Chun Kee Chung
Organization
Seoul National Unversity College of Medicine
chungc@snu.ac.kr
+82-2-2072-2357

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
ultrasonic bone osteotome
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 2, 2015

Study Start

June 2, 2015

Primary Completion

February 4, 2018

Study Completion

February 4, 2018

Last Updated

March 27, 2025

Results First Posted

March 27, 2025

Record last verified: 2025-03

Locations

KR(1)