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Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.
There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1~3 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C3 laminectomy with C4-6 laminoplasty | Experimental | Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. |
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| C3-6 laminoplasty | Active Comparator | Cervical myelopathy patients who underwent C3-6 laminoplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C3 laminectomy | Procedure | C3 laminectomy preserving semispinalis cervicis inserted into the axis. |
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| Measure | Description | Time Frame |
|---|---|---|
| C2-C7 Lordosis | Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| the Neck Disability Index (NDI) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| Measure | Description | Time Frame |
|---|---|---|
| C2-C3 Lordosis | Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| C4-C7 Lordosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Kee Chung, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Korea | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32387294 | Background | Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6. | |
| 32941312 |
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| ID | Title | Description |
|---|---|---|
| FG000 | C3 Laminectomy With C4-6 Laminoplasty | Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis. |
| FG001 | C3-6 Laminoplasty |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 5, 2017 |
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A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty
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Using a generator of www.randomization.com, 100 subjects randomized into blocks of 50 and 50. To reproduce this plan, use the seed 3169 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.
and (case-sensitive) treatment labels as entered originally. After randomization of 100 subjects, additional 26 subjects randomized into blocks of 13 and13. To reproduce this plan, use the seed 5134 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.
| C3 laminoplasty | Procedure | Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis. |
|
Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| Cervical Sagittal Vertical Axis (cSVA) | Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| T1 Slope | Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| T1 Slope Minus Cervical Lordosis | Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| C2-C3 Interlaminar Spontaneous Fusion | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. | at 2 year |
| EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO). | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| Posterior Neck With Numering Rating Scale (NRS-N) | Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| Upper Limb Pain With Numering Rating Scale (NRS-L) | Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
| Estimated Intraoperative Blood Loss | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. | Intraoperative |
| Operative Time | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). | Intraoperative |
| Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068. |
| 33086255 | Background | Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100. |
| 27851661 | Background | Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974. |
| 16284593 | Background | Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. doi: 10.1097/01.brs.0000186332.66490.ba. |
Cervical myelopathy patients who underwent C3-6 laminoplasty.
C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
| COMPLETED |
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| NOT COMPLETED |
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patients with more than postoperative 1year follow up were analysed.
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| ID | Title | Description |
|---|---|---|
| BG000 | C3 Laminectomy With C4-6 Laminoplasty | Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis. |
| BG001 | C3-6 Laminoplasty | Cervical myelopathy patients who underwent C3-6 laminoplasty. C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Disease | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | Kg/m2 |
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| 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 | C2-C7 Lordosis | Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | ° | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Primary | the Neck Disability Index (NDI) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. | Posted | Least Squares Mean | Standard Error | score | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | C2-C3 Lordosis | Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | ° | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | C4-C7 Lordosis | Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | ° | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | Cervical Sagittal Vertical Axis (cSVA) | Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | mm | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | T1 Slope | Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | ° | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | T1 Slope Minus Cervical Lordosis | Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | Posted | Least Squares Mean | Standard Error | ° | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | C2-C3 Interlaminar Spontaneous Fusion | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. | Posted | Count of Participants | Participants | at 2 year |
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| Secondary | EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO). | Posted | Least Squares Mean | Standard Error | score | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | Posterior Neck With Numering Rating Scale (NRS-N) | Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | Posted | Least Squares Mean | Standard Error | score | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | Upper Limb Pain With Numering Rating Scale (NRS-L) | Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | Posted | Least Squares Mean | Standard Error | score | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) |
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| Secondary | Estimated Intraoperative Blood Loss | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. | Posted | Mean | Standard Deviation | cc | Intraoperative |
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| Secondary | Operative Time | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). | who completed 1-year to 3-year follow-up | Posted | Mean | Standard Deviation | minutes | Intraoperative |
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1 year
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | C3 Laminectomy With C4-6 Laminoplasty | Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG001 | C3-6 Laminoplasty | Cervical myelopathy patients who underwent C3-6 laminoplasty. C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis. | 0 | 61 | 0 | 61 | 0 | 61 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Researcher of Clinical Trials | Seoul National University Hospital | +821049051485 | junhiya@snu.ac.kr |
| Jan 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D017887 | Ossification of Posterior Longitudinal Ligament |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009999 | Ossification, Heterotopic |
| D010335 | Pathologic Processes |
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| Ossification of posterior longitudinal ligament |
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