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Completed

NCT Number: NCT03798496

Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture

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.

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Key information

Conditions

Galeazzi's Fracture Arm Injuries Forearm Injuries Fractures, Bone Radius Fractures Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Reduction and Internal Fixation

Procedure

Open reduction of the Galeazzi fracture dislocation with a plate.

Other names: DRUJ reduction with Kirschner wire

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: Galeazzi

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2019
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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