Arthrodesis
Conditions
Keywords
arthrodesiss, cervical vertebra, laminoplasty
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.
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.
Interventions
DEVICEultrasonic osteotome
making gutter with ultrasonic osteotome
DEVICEdrill
making gutter with drill
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
ultrasonic bone osteotome
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bone Fusion | 6 months | Bone fusion based on computed tomography scan taken at postoperative 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Amount | during operation | bleeding amount through suction and gauze, unit mL |
| Fracture of Laminar | during operation | The number of patients with lamina fractures. |
| Neck Pain/Arm Pain | postop 1 year | 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. |
| Functional Outcome | postop 1 year | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasonic Osteotome making gutter on the hinge side of lamina with ultrasonic osteotome
ultrasonic osteotome: making gutter with ultrasonic osteotome | 95 |
| Drill making gutter on the hinge side of lamina with conventional drill
drill: making gutter with drill | 95 |
| Total | 190 |
Baseline characteristics
| Characteristic | Ultrasonic Osteotome | Drill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 37 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 58 Participants | 118 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 95 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 95 Participants | 95 Participants | 190 Participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 62 Participants | 61 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 95 |
| other Total, other adverse events | 0 / 95 | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
Number of Participants With Bone Fusion
Bone fusion based on computed tomography scan taken at postoperative 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonic Osteotome | Number of Participants With Bone Fusion | 43 Participants |
| Drill | Number of Participants With Bone Fusion | 60 Participants |
Secondary
Bleeding Amount
bleeding amount through suction and gauze, unit mL
Time frame: during operation
Population: bleeding amount through suction and gauze Date from all participants in this study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Osteotome | Bleeding Amount | 159.6 ml | Standard Deviation 155.9 |
| Drill | Bleeding Amount | 227.4 ml | Standard Deviation 139.5 |
Secondary
Fracture of Laminar
The number of patients with lamina fractures.
Time frame: during operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonic Osteotome | Fracture of Laminar | 23 Participants |
| Drill | Fracture of Laminar | 25 Participants |
Secondary
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.
Time frame: postop 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Osteotome | Functional Outcome | 11.30 percentage score on a 0-100% scale | Standard Deviation 0.95 |
| Drill | Functional Outcome | 10.79 percentage score on a 0-100% scale | Standard Deviation 0.97 |
Secondary
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.
Time frame: postop 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonic Osteotome | Neck Pain/Arm Pain | Neck pain | 2.15 score on a scale | Standard Deviation 0.25 |
| Ultrasonic Osteotome | Neck Pain/Arm Pain | Arm pain | 3.02 score on a scale | Standard Deviation 0.29 |
| Drill | Neck Pain/Arm Pain | Neck pain | 1.96 score on a scale | Standard Deviation 0.25 |
| Drill | Neck Pain/Arm Pain | Arm pain | 2.39 score on a scale | Standard Deviation 0.3 |