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

NCT03649425 | Unknown

• 1 other identifier: 84939418.6.0000.5342
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

External Fixation Pin Site Infection

Keywords

infection; pin site; external fixator; hydroxyapatite coated

Outcome Measures

Primary Outcomes (2)

• compare infectious complications

  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

  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 Outcomes (1)

• risk factors and comorbities associated

  April 2018 and December 2019

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead
• Instituto de Ortopedia e Traumatologia de Passo Fundo: collaborator
• Universidade de Passo Fundo: collaborator

Study Sites (1)

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

RECRUITING

MeSH Terms

Conditions

Infections

Central Study Contacts

Cristhopher L Stoffel

CONTACT

5554981249707; cristoffel@outlook.com

Mauro Salles

CONTACT

5511985360055; salles.infecto@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: May 14, 2018
• Primary Completion: November 25, 2019
• Study Completion: May 15, 2020
• Last Updated: August 28, 2018

Record last verified: 2018-05

Locations

BR (1)