NCT05006495

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	C3 laminectomy	C3 laminectomy preserving semispinalis cervicis inserted into the axis.
PROCEDURE	C3 laminoplasty	Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

Timeline

• Start date: 2017-03-20
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2021-08-16
• Last updated: 2024-06-21
• Results posted: 2024-06-21

Locations

1 site across 1 country: South Korea