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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic osteotome | Active Comparator | making gutter on the hinge side of lamina with ultrasonic osteotome |
|
| Drill | Sham Comparator | making gutter on the hinge side of lamina with conventional drill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasonic osteotome | Device | making gutter with ultrasonic osteotome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bone Fusion | Bone fusion based on computed tomography scan taken at postoperative 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Amount | bleeding amount through suction and gauze, unit mL | during operation |
| Fracture of Laminar | The number of patients with lamina fractures. |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39350186 | Derived | 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. | |
| 31435653 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasonic Osteotome | making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome |
| FG001 | Drill | making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients underwent cervical laminoplasty
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasonic Osteotome | making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome |
| BG001 | Drill | making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Bone Fusion | Bone fusion based on computed tomography scan taken at postoperative 6 months | Posted | Count of Participants | Participants | 6 months |
|
1 year
neurological deterioration, any unexpected complicaitons All those complication did not occur during follow-up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasonic Osteotome | making gutter on the hinge side of lamina with ultrasonic osteotome ultrasonic osteotome: making gutter with ultrasonic osteotome |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chun Kee Chung | Seoul National Unversity College of Medicine | +82-2-2072-2357 | chungc@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2015 | Nov 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059385 | Plyometric Exercise |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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ultrasonic bone osteotome
| drill | Device | making gutter with drill |
|
|
| 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. | 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. | postop 1 year |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Bleeding Amount | bleeding amount through suction and gauze, unit mL | bleeding amount through suction and gauze Date from all participants in this study | Posted | Mean | Standard Deviation | ml | during operation |
|
|
|
| Secondary | Fracture of Laminar | The number of patients with lamina fractures. | Posted | Count of Participants | Participants | during operation |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | postop 1 year |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage score on a 0-100% scale | postop 1 year |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Drill | making gutter on the hinge side of lamina with conventional drill drill: making gutter with drill | 0 | 95 | 0 | 95 | 0 | 95 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |