C3 Laminectomy With Cervical Laminoplasty

NCT ID: NCT06374680

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2021-12-31

Brief Summary

1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.

2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.

3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty.

Detailed Description

Surgery is performed under general anesthesia as before, followed by posterior cervical incision. In one group, the cervical spine of the C3 is removed using a drill and punch and C4-6 laminoplasty will be performed. In the other group, C3-6 laminoiplasty will be performed. Postoperative suturing and subject management are the same as existing patient care policies. Follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. The degree of the neck pain is measured using NDI and VAS for each outpatient f/u.

Conditions

Neck Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

C3 laminectomy

laminectomy at C3 level and laminoplasty at C4-6 level

laminectomy at C3 level

Intervention Type: PROCEDURE

laminectomy at C3 level

C3 laminoplasty

laminoplasty at C3-6 level

laminectomy at C3 level

Intervention Type: PROCEDURE

laminectomy at C3 level

Interventions

laminectomy at C3 level

laminectomy at C3 level

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• cervical stenosis

Exclusion Criteria

• metastatic tumor
• fracture
• previous cervical spine surgery (posterior approach)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chun Kee Chung

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun Kee Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

C3 ectomy

Identifier Type: -

Identifier Source: org_study_id