Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

June 27, 2021 updated by: Peking University Third Hospital
To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF).

Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Contact

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

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From January 2010 to December 2014

Description

Inclusion Criteria:

  • typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.

Exclusion Criteria:

  • previous spine surgery, acute spinal fracture, infection, and tumor.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
patients in this group destructed the posterior ligamentous complex of the adjacent segment
Procedure: total laminectomy
Total laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels.
group 2
patients in this group did not destruct the of the posterior ligamentous complex of the adjacent segment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Incidences of adjacent segment degeneration
Time Frame: From the end of treatment to more than 8 years
the Incidences of adjacent segment degeneration
From the end of treatment to more than 8 years

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Weishi Li, 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 (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2019232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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