NCT06374680

Brief Summary

  1. 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. 2.Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
  3. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

4.8 years

First QC Date

August 24, 2017

Last Update Submit

April 19, 2024

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • neck pain

    Numerical rating pain score on neck, 0\~10, 0 is no pain, 10 is maximum pain

    1 year

Study Arms (2)

C3 laminectomy

laminectomy at C3 level and laminoplasty at C4-6 level

Procedure: laminectomy at C3 level

C3 laminoplasty

laminoplasty at C3-6 level

Procedure: laminectomy at C3 level

Interventions

laminectomy at C3 levelPROCEDURE

laminectomy at C3 level

C3 laminectomyC3 laminoplasty

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cervical stenosis who should undergo cervical laminoplasty

You may qualify if:

  • cervical stenosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chun Kee Chung, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 24, 2017

First Posted

April 19, 2024

Study Start

March 20, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)