Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures

October 16, 2020 updated by: Mahmoud Samir Mondy, Assiut University

Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures

Comparing clinical outcome between patients who underwent metal removal and those who retained the metal

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-60 years
  • Posterior fixation
  • Six to nine months after fixation
  • Neurologically free patient
  • Fracture consolidation detected by ct
  • Types A3&A4 fractures

Exclusion Criteria:

  • unstable fractures B&C
  • pathological fractures
  • multilevel fractures
  • poly trauma patients

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metal removal
Procedure: Metal removal
Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures
No Intervention: Metal retention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-5L questionnaire
Time Frame: Baseline
Measuring the quality of life after metal removal
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: Baseline
Measuring the quality of life after metal removal or without removal
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 15, 2020

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Metal removal

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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