C3 Laminectomy With Cervical Laminoplasty

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06374680
• Other study ID #: C3 ectomy
• Status: Withdrawn
• Start date: March 20, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• cervical stenosis

Exclusion Criteria:

• metastatic tumor

• fracture

• previous cervical spine surgery (posterior approach)

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• laminectomy at C3 level
laminectomy at C3 level

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neck pain	Numerical rating pain score on neck, 0~10, 0 is no pain, 10 is maximum pain	1 year