Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture (Galeazzi)

July 12, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Role of the Interosseous Membrane and TFCC in DRUJ Stability in Galeazzi´s Fracture: Anatomical and Biomechanical Study

Most Galeazzi fractures can be treated adequately with open reduction and internal fixation (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of the TFCC.The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation, displacement and instability associated with the sequential sectioning of the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a Galeazzi fracture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Instability of the DRUJ is a common clinical problem associated with Galeazzi fracture. Stability of the DRUJ is primarily provided by both the bony anatomy of the sigmoid notch of the radius and ulnar head and the soft tissues surrounding the joint. The interosseous membrane plays an important role in DRUJ stability but the TFCC is the major soft tissue stabilizer of the DRUJ. The Central Band works as a restraint on the radius from proximal migration in cooperation with the radial head and the TFCC and also works as a load transmitter between the radius and ulnar to redistribute load. Some investigators suggested that the distal membranous portion and DOB stabilizes the DRUJ when TFCC is disrupted. Watanabe et al. (2005) insisted on the importance of DOB, which constrained volar and dorsal instability of the radius at the DRUJ in all forearm rotation positions. The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation in the simulation of a Galeazzi fracture.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anatomical and biomechanical study: Twelve specimens from the Human Anatomy Department.

Clinical study: Review of reports (X-rays) about patients with Galeazzi fracture-dislocation treated with ORIF.

Description

Inclusion Criteria:

Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open reduction and internal fixation (ORIF).

Exclusion Criteria:

  • Children
  • Other types of forearms fractures

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

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Displacement in distal radius fracture
Time Frame: 12 months
The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen.
12 months
Stability in the DRU joint
Time Frame: 12 months
Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method).
12 months

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Claudia Lamas, Ph D, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 (Actual)

December 18, 2018

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-GAL-2018-75

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After the results were obtained we send the results to the statistical department to correlate the outcomes.

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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