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

NCT05006495 | Completed Results

• 1 other identifier: 1610-136-804
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laminoplasty; Laminectomy

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (11)

• C2-C3 Lordosis

  at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

• C4-C7 Lordosis

  at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

• Cervical Sagittal Vertical Axis (cSVA)

  at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

• T1 Slope

  at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

• T1 Slope Minus Cervical Lordosis

  at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

Study Arms (2)

C3 laminectomy with C4-6 laminoplasty

EXPERIMENTAL

Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.

Procedure: C3 laminectomy

C3-6 laminoplasty

ACTIVE COMPARATOR

Cervical myelopathy patients who underwent C3-6 laminoplasty.

Procedure: C3 laminoplasty

Interventions

C3 laminectomy PROCEDURE

C3 laminectomy preserving semispinalis cervicis inserted into the axis.

C3 laminectomy with C4-6 laminoplasty

C3 laminoplasty PROCEDURE

Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

C3-6 laminoplasty

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical stenosis patients with or without cervical myelopathy.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

Location

Related 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.

  PMID: 32387294 BACKGROUND

• 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.

  PMID: 32941312 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.

  PMID: 33086255 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.

  PMID: 27851661 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.

  PMID: 16284593 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Ossification of Posterior Longitudinal Ligament

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes

Results Point of Contact

• Title: Researcher of Clinical Trials
• Organization: Seoul National University Hospital

junhiya@snu.ac.kr

+821049051485

Study Officials

• Chun Kee Chung, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 16, 2021
• Study Start: March 20, 2017
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)