Clinical trial NCT05006495: Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Official title: Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelopathy Cervical
Kyphosis Post Surgical
Neck Pain
Ossification of Posterior Longitudinal Ligament
Cervical Spondylosis With Myelopathy
Keywords: Laminoplasty
Laminectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty
Primary purpose: TREATMENT

Brief summary: Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Cervical stenosis patients with or without cervical myelopathy.

Exclusion Criteria:

* Metastatic cancer patients.
* Any combined fracture.
* Previous surgery to cervical spine.
* inflammatory joint disease
* psychiatric illness

Primary outcomes:
measure: C2-C7 Lordosis
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: the Neck Disability Index (NDI)
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Secondary outcomes:
measure: C2-C3 Lordosis
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: C4-C7 Lordosis
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: Cervical Sagittal Vertical Axis (cSVA)
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: T1 Slope
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: T1 Slope Minus Cervical Lordosis
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: C2-C3 Interlaminar Spontaneous Fusion
timeFrame: at 2 year
measure: EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: Posterior Neck With Numering Rating Scale (NRS-N)
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: Upper Limb Pain With Numering Rating Scale (NRS-L)
timeFrame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
measure: Estimated Intraoperative Blood Loss
timeFrame: Intraoperative
measure: Operative Time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
affiliation: Seoul National University Hospital
name: Chun Kee Chung, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.