Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex

August 6, 2021 updated by: Peking University Third Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Expansive laminoplasty of posterior cervical canal has been widely used for the treatment of cervical spondylotic myelopathy with cervical spinal stenosis and ossification of the posterior longitudinal ligament since Hirabayashi et al. described it in the 1970s. Traditional single-door surgery requires extensive dissection of both paravertebral muscles and ligaments, and resect part of the spinous process. Postoperative complications (axial neck pain, stiffness, cervical kyphosis, reduced range of motion, etc.) are also related to that in degree. In order to reduce the damage to the posterior cervical structure and reduce the associated complications, in the 1990s, Yoshihiko Oshima et al. introduced the expansive laminoplasty of the spinal canal with one side of the posterior ligamentwith muscle complex attached to the spinous process. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Posterior Cervical Muscle Volume
Time Frame: preoperation
the volume of Posterior Cervical Muscle
preoperation
Posterior Cervical Muscle Volume
Time Frame: 2 years after operation
the volume of Posterior Cervical Muscle
2 years after operation
C5 palsy
Time Frame: 2 years after operation
C5 nerve palsy
2 years after operation
axial syndrome
Time Frame: 2 years after operation
axial syndrome
2 years after operation
reoperation
Time Frame: 2 years after operation
reoperation
2 years after operation
door closing
Time Frame: 2 years after operation
door closing
2 years after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mJOA
Time Frame: 2 years after operation
modified Japanese orthopaedics association
2 years after operation
NDI
Time Frame: 2 years after operation
neck disability index
2 years after operation
VAS
Time Frame: 2 years after operation
visual analogue scale
2 years after operation
ROM
Time Frame: 2 years after operation
range of motion
2 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yu Sun, Dr., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LM2020161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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