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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006495
• Other study ID #: 1610-136-804
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: October 28, 2022

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylosis With Myelopathy
• Kyphosis
• Myelopathy Cervical
• Neck Pain
• Ossification of Posterior Longitudinal Ligament
• Spinal Cord Diseases
• Spondylosis

Intervention

Procedure:
• C3 laminectomy
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
• C3 laminoplasty
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Primary	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)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Secondary	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
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).	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
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.	at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Secondary	Estimated Intraoperative Blood Loss	Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.	Intraoperative
Secondary	Operative Time	Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).	Intraoperative