Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

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 Neck Disability Index(NDI), the Visual Analog Scale(VAS) of neck pain, and the C2-7 Spine Cobb angle at postoperative 1 year.

Myelopathy Cervical, Kyphosis Post Surgical, Neck Pain, Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy

A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty

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.

Measuring pain intensity of the posterior neck with visual analog scale (VAS), rated 1 to 10 with 10 being the most severe pain level.

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.

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).

Measuring C2-C3 lordosis angle, C4-C7 lordosis angle, T1 slope angle, T1 slope - 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.

distance between C2 plumb line and C7) by using standard lateral cervical x-ray series with the patients standing in a neutral position.

Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.

Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).

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

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.