C3 Laminectomy With Cervical Laminoplasty

Withdrawn

• Conditions: Neck Pain
• Interventions: Procedure: laminectomy at C3 level

• Registration Number: NCT06374680
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-08-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• cervical stenosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C3 laminoplasty	laminectomy at C3 level	laminoplasty at C3-6 level
C3 laminectomy	laminectomy at C3 level	laminectomy at C3 level and laminoplasty at C4-6 level

Primary Outcome Measures

Name	Time	Method
neck pain	1 year	Numerical rating pain score on neck, 0\~10, 0 is no pain, 10 is maximum pain

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of