Galeazzi's FractureGaleazziNCT03798496
Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture
An observational study of Galeazzi's Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Galeazzi's Fracture
- What is being tested?
- Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2018to 31 Jan 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open reduction and internal fixation (ORIF).
Who cannot join
- Children
- Other types of forearms fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Galeazzi's Fracture
- Being tested
- Open reduction and internal fixation
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Also called DRUJ reduction with Kirschner wire
Open reduction of the Galeazzi fracture dislocation with a plate.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start18 Dec 2018
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Galeazzi's FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lamas, Ph D, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798496
- Sponsor's protocol ID
- IIBSP-GAL-2018-75
- Acronym
- Galeazzi
- Status last verified
- Jul 2021
- First submitted
- 19 Dec 2018
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the results were obtained we send the results to the statistical department to correlate the outcomes.
Publications
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.
PubMed 25703865Kitamura 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.
PubMed 21872404Loeffler 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.
PubMed 24315636Moritomo 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.
PubMed 22721462Noda 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.
PubMed 19211201Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I.
PubMed 8463602Riggenbach 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.
PubMed 24436838Riggenbach 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.
PubMed 26518322Werner 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.
PubMed 28428910Werner 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.
PubMed 22100813
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Interosseous Membrane and TFCC in DRUJ Stability in Galeazzi´s Fracture: Anatomical and Biomechanical Study
- ClinicalTrials.gov ID
- NCT03798496
- Acronym / sponsor ID
- Galeazzi / IIBSP-GAL-2018-75
- Conditions
- Galeazzi's Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open reduction and internal fixation (ORIF).
Key exclusion criteria (2 listed)
- Children
- Other types of forearms fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction and internal fixationAlso: DRUJ reduction with Kirschner wireOpen reduction of the Galeazzi fracture dislocation with a plate. | Procedure or surgery | – |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 25703865Farr 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.
- Background: PubMed 21872404Kitamura 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.
- Background: PubMed 24315636Loeffler 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.
- Background: PubMed 22721462Moritomo 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.
- Background: PubMed 19211201Noda 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.
- Background: PubMed 8463602Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I.
- Background: PubMed 24436838Riggenbach 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.
- Background: PubMed 26518322Riggenbach 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.
- Background: PubMed 28428910Werner 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.
- Background: PubMed 22100813Werner 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.
- Individual participant dataSharing planned: No. After the results were obtained we send the results to the statistical department to correlate the outcomes.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Lamas, Ph D principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Galeazzi's Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement in distal radius fracture (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798496, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.