Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
NCT ID: NCT05006495
Last Updated: 2024-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2017-03-20
2022-10-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
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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.
C3-6 laminoplasty
Cervical myelopathy patients who underwent C3-6 laminoplasty.
C3 laminoplasty
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Interventions
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C3 laminectomy
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
C3 laminoplasty
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any combined fracture.
* Previous surgery to cervical spine.
* inflammatory joint disease
* psychiatric illness
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Chun Kee Chung
Professor
Principal Investigators
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Chun Kee Chung, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Korea, South Korea
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1610-136-804
Identifier Type: -
Identifier Source: org_study_id
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