ArthrodesisSONONCT02487901
Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
A study testing ultrasonic osteotome and drill in people with Arthrodesis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Arthrodesis
- What is being tested?
- ultrasonic osteotome and drill
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2015to 4 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
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.
Read the detailed 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.
- Conditions
- Arthrodesis
- Being tested
- ultrasonic osteotome, drill
- Keywords
- arthrodesiss, cervical vertebra, laminoplasty
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic osteotomeDevice
Also called misonix
making gutter with ultrasonic osteotome
drillDevice
Also called electronic drill
making gutter with drill
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic osteotome | Active comparator | making gutter on the hinge side of lamina with ultrasonic osteotome Receives: Device: ultrasonic osteotome |
| Drill | Sham comparator | making gutter on the hinge side of lamina with conventional drill Receives: Device: drill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bone Fusion
Bone fusion based on computed tomography scan taken at postoperative 6 months
Measured: 6 months
Secondary outcomes (4)
Bleeding Amount
bleeding amount through suction and gauze, unit mL
Measured: during operation
Fracture of Laminar
The number of patients with lamina fractures.
Measured: during operation
Neck Pain/Arm Pain
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.
Measured: postop 1 year
Functional Outcome
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.
Measured: postop 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start2 Jun 2015
- Primary completion4 Feb 2018
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthrodesisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487901
- Sponsor's protocol ID
- SONO1
- Acronym
- SONO
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2015
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 39350186Kim 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.
PubMed 31435653
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
- ClinicalTrials.gov ID
- NCT02487901
- Acronym / sponsor ID
- SONO / SONO1
- Conditions
- Arthrodesis
- Keywords
- arthrodesiss, cervical vertebra, laminoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 4 Feb 2018 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic osteotome | Active comparator | Device: ultrasonic osteotomemaking gutter on the hinge side of lamina with ultrasonic osteotome |
| Drill | Sham comparator | Device: drillmaking gutter on the hinge side of lamina with conventional drill |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonic osteotomeAlso: misonixmaking gutter with ultrasonic osteotome | Device | Ultrasonic osteotome |
| drillAlso: electronic drillmaking gutter with drill | Device | Drill |
Primary outcome
Number of Participants With Bone Fusion
Time frame: 6 months
Bone fusion based on computed tomography scan taken at postoperative 6 months
4 secondary outcomes
Bleeding Amount
Time frame: during operation
Fracture of Laminar
Time frame: during operation
Neck Pain/Arm Pain
Time frame: postop 1 year
Functional Outcome
Time frame: postop 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39350186Seo 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.
- Derived from this study: PubMed 31435653Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic osteotome and drill in people with Arthrodesis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Bone Fusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.