Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture

Galeazzi's Fracture Clinical Trial

— Galeazzi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798496
• Other study ID #: IIBSP-GAL-2018-75
• Status: Completed
• Start date: December 18, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Galeazzi's Fracture

Intervention

Procedure:
• Open reduction and internal fixation
Open reduction of the Galeazzi fracture dislocation with a plate.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Farr LD, Werner FW, McGrattan ML, Zwerling SR, Harley BJ. Anatomy and biomechanics of the forearm interosseous membrane. J Hand Surg Am. 2015 Jun;40(6):1145-51.e2. doi: 10.1016/j.jhsa.2014.12.025. Epub 2015 Feb 20. — View Citation

Kitamura T, Moritomo H, Arimitsu S, Berglund LJ, Zhao KD, An KN, Rizzo M. The biomechanical effect of the distal interosseous membrane on distal radioulnar joint stability: a preliminary anatomic study. J Hand Surg Am. 2011 Oct;36(10):1626-30. doi: 10.1016/j.jhsa.2011.07.016. Epub 2011 Aug 26. — View Citation

Loeffler BJ, Green JB, Zelouf DS. Forearm instability. J Hand Surg Am. 2014 Jan;39(1):156-67. doi: 10.1016/j.jhsa.2013.07.010. Epub 2013 Dec 6. Review. — View Citation

Moritomo H. The distal interosseous membrane: current concepts in wrist anatomy and biomechanics. J Hand Surg Am. 2012 Jul;37(7):1501-7. doi: 10.1016/j.jhsa.2012.04.037. Review. — View Citation

Noda K, Goto A, Murase T, Sugamoto K, Yoshikawa H, Moritomo H. Interosseous membrane of the forearm: an anatomical study of ligament attachment locations. J Hand Surg Am. 2009 Mar;34(3):415-22. doi: 10.1016/j.jhsa.2008.10.025. Epub 2009 Feb 11. — View Citation

Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. — View Citation

Riggenbach MD, Conrad BP, Wright TW, Dell PC. Distal oblique bundle reconstruction and distal radioulnar joint instability. J Wrist Surg. 2013 Nov;2(4):330-6. doi: 10.1055/s-0033-1358546. — View Citation

Riggenbach MD, Wright TW, Dell PC. Reconstruction of the Distal Oblique Bundle of the Interosseous Membrane: A Technique to Restore Distal Radioulnar Joint Stability. J Hand Surg Am. 2015 Nov;40(11):2279-82. doi: 10.1016/j.jhsa.2015.08.019. Review. — View Citation

Werner FW, LeVasseur MR, Harley BJ, Anderson A. Role of the Interosseous Membrane in Preventing Distal Radioulnar Gapping. J Wrist Surg. 2017 May;6(2):97-101. doi: 10.1055/s-0036-1584545. Epub 2016 Jun 20. — View Citation

Werner FW, Taormina JL, Sutton LG, Harley BJ. Structural properties of 6 forearm ligaments. J Hand Surg Am. 2011 Dec;36(12):1981-7. doi: 10.1016/j.jhsa.2011.09.026. Epub 2011 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Displacement in distal radius fracture	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
Primary	Stability in the DRU joint	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