COMPARATIVE PROSPECTIVE STUDY OF COMPLICATIONS FOUND IN THE PINS OF EXTERNAL FIXERS COMPARING STEEL PINS AND PINS COATED WITH HYDROXIAPATITA

August 27, 2018 updated by: Faculdade de Ciências Médicas da Santa Casa de São Paulo

COMPARATIVE PROSPECTIVE STUDY OF SURFACE AND DEEP COMPLICATIONS FOUND IN THE PINS OF EXTERNAL FIXERS COMPARING STEEL PINS AND PINS COATED WITH HYDROXIAPATITA

The present study is a prospective non-randomized and comparative study of patients undergoing surgical treatment with external fixators of any type, between May 2018 and May 2020, in the city of Passo Fundo, RS, Brazil, in the São Vicente de Paulo hospitals. A study in which we compared infection rates, pin loosening and complications found in external fixators made with hydroxyapatite coated pins and uncoated steel pins.

Study Overview

Status

Status

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

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

We will use as a guide to define the degree of infection and the conduct to be taken in the classification of Mas Oxford Nuffield (Table 3), therefore the presence of infection occurring in patients classified as Grade 2 - erythema of the skin, serous or purulent secretion, pain and sensitivity in soft tissues capable of mobilizing with analgesia. We will also send to the culture the tip of two pins removed from each patient to evaluate possible colonization and to compare with the degree of classification presented in the pin in question, we will do this with a pin without signal of infection and with the pin with the highest degree of classification presented in each patient at the time of the external fixator removal.

We will use as a method of insertion of the pin the pre-perforation irrigated before the insertion of the pins, to decrease the chances of thermal necrosis and consequent release or infection. We will use steel Shanz pins coated with hydroxyapatite or not in size between 5-6mm. Comorbidities and risk factors such as diabetes mellitus, smoking, immunodepression, among others, will be computed for later comparison with the data collected. The degree of classification of the fractures, as well as the pathologies that were treated with the fixators, as well as the residence time with the external fixator will also be computed for later comparison with the data collected.

For the elaboration of this study, the patients will be prospectively observed, which will be submitted to the treatment of several pathologies with external fixators, of any type. The occurrence of infection and / or loosening of the pins, as well as the influence of risk factors and the cultural examination results of the pins removed at the end of the treatment will be recorded. The objectives of the study are to comparatively evaluate the differences in complications of infection, pin loosening and microbiological results of cultural examinations, between patients submitted to external fixators with uncoated steel pins and steel pins coated with hydroxyapatite. The influence of risk factors on outcomes will also be observed.

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 (Anticipated)

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.
119

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080

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

Probability Sample

Study Population

Patients who underwent surgical treatment with external fixators for at least 2 weeks, regardless of age, gender and comorbidities.

Description

Inclusion Criteria:

  • We will select for the study patients who agree to participate, signing the commitment term for data use, and who underwent surgical treatment with external fixation of any type both for fracture treatment and correction of deformities, treatment of osteomyelitis and or pseudoarthrosis , for a minimum period of 2 weeks.

Exclusion Criteria:

  • We will exclude patients who do not agree to participate in the study, patients who have had external fixation for less than 2 weeks, and patients in whom we have lost 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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
hydroxyapatite coated pins
Patients submitted to surgical treatment with external fixators using pins coated with hydroxyapatite.
uncoated steel pins
Patients submitted to surgical treatment with external fixators using uncoated steel pins.

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
compare infectious complications
Time Frame: April 2018 and December 2019
To compare superficial and deep infectious complications associated with the presence of external fixation pins. To evaluate the incidence and degree of infection at pin insertion sites, osteomyelitis and wound infection, comparatively between hydroxyapatite and uncoated pins.
April 2018 and December 2019
Evaluate the incidence of loosening of the pins
Time Frame: April 2018 and December 2019
To evaluate the incidence of pin loosening, comparatively between pins coated with hydroxyapatite and uncoated pins, in the external fixators.
April 2018 and December 2019

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
risk factors and comorbities associated
Time Frame: April 2018 and December 2019
To evaluate the risk factors and comorbidities associated with infectious complications and pin loosening in the patients participating in the study
April 2018 and December 2019

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.
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidade de Passo Fundo
Instituto de Ortopedia e Traumatologia de Passo Fundo

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.
May 14, 2018

Primary Completion (ANTICIPATED)

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.
November 25, 2019

Study Completion (ANTICIPATED)

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.
May 15, 2020

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).
August 24, 2018

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 27, 2018

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 28, 2018

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 28, 2018

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 27, 2018

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.
May 1, 2018

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.
  • 84939418.6.0000.5342

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

product manufactured in and exported from the U.S.

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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