Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration

July 11, 2021 updated by: Peking University Third Hospital
The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

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

Study Contact Backup

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From January 2010 to June 2018, patients with lumbar spine disease hospitalized in orthopedics were screened out to meet the criteria

Description

Inclusion Criteria:

  • For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation;
  • X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up;
  • Follow-up for at least 2 years after revision;

Exclusion Criteria:

  • Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.

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

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) scores of low back pain and leg pain
Time Frame: 2 years after revision surgery
Visual Analog Scale (VAS) scores of low back pain and leg pain
2 years after revision surgery
Japanese Orthopedic Association (JOA) score
Time Frame: 2 years after revision surgery
Japanese Orthopedic Association (JOA) score
2 years after revision surgery
Oswestry Disability Index (ODI)
Time Frame: 2 years after revision surgery
Oswestry Disability Index (ODI)
2 years after revision surgery

Collaborators and Investigators

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

Sponsor

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)

August 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M2020288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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