NCT05001685

Brief Summary

In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

August 12, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

July 1, 2021

Last Update Submit

August 6, 2021

Conditions

Keywords

Single Open-door Expansive LaminoplastyPreserving the Unilateral Ligament With Muscle ComplexPostoperative ComplicationsEffects on Posterior Cervical Muscle Volume

Outcome Measures

Primary Outcomes (6)

  • Posterior Cervical Muscle Volume

    the volume of Posterior Cervical Muscle

    preoperation

  • Posterior Cervical Muscle Volume

    the volume of Posterior Cervical Muscle

    2 years after operation

  • C5 palsy

    C5 nerve palsy

    2 years after operation

  • axial syndrome

    axial syndrome

    2 years after operation

  • reoperation

    reoperation

    2 years after operation

  • door closing

    door closing

    2 years after operation

Secondary Outcomes (4)

  • mJOA

    2 years after operation

  • NDI

    2 years after operation

  • VAS

    2 years after operation

  • ROM

    2 years after operation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.

You may qualify if:

  • From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.Complete preoperative and postoperative diagnosis and treatment data of our hospital were available, and the follow-up time was ≥2 years.

You may not qualify if:

  • Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yu Sun, Dr.

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

August 12, 2021

Study Start

August 1, 2019

Primary Completion

August 31, 2020

Study Completion

June 1, 2021

Last Updated

August 12, 2021

Record last verified: 2021-06

Locations