Vascularity of the Ulna and Its Association With Forearm Nonunion

Forearm Fracture Clinical Trial

— Nonunion  

Official title:

Anatomical Study About the Vascularization of the Ulna: Vascular and Mechanical Risk Factors Associated With Forearm Nonunion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805204
• Other study ID #: IIBSP-CUB-2018-61
• Status: Completed
• Start date: December 3, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: October 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

Clinical Trial Summary

Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely disabling and challenging to treat. Multiple factors have been associated with the establishment of this non-union. Many non-unions are associated with soft tissue damage, fracture site vascularity, persistent instability, infection, and the surgical treatment technique. This study analysed the systemic conditions and local factors associated with the failure of bone fracture healing The aim of our study was to identify the risk factors for ulnar nonunion

Description:

In the anatomical study we investigated the extraosseous and intraosseous blood supply in fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low vascularity with the usual areas that patients have ulnar nonunion.

In the clinical study we retrospectively reviewed a cohort of ulnar fractures treated surgically with open reduction and internal fixation (ORIF), during a period of 10 years (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1 year. We defined non-union if there was no radiological consolidation of the fracture after this period, and we classified them according to Weber classification. We assessed risk factors like: fracture site vascularity, surgical treatment technique, biological factors of the patient, and the fracture's mechanism. We correlated data and associated risk factors from the anatomical and the clinical studies.

Data were analysed using SPSS software system version 21. Multivariate regression analysis was performed to assess independent risk factors of ulnar non-union. Chi square test or Fisher exact test was used to compare categorical measurements. Statistical significance was considered as p less than 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 30, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults from 18 to 90 years old

• Forearm ulnar nonunion

Exclusion Criteria:

• Children

• Other types of forearm fractures

Related Conditions & MeSH terms

• Forearm Fracture

Intervention

Procedure:
• Open reduction and internal fixation (ORIF)
ORIF with a forearm 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 (5)

Bartonícek J, Kozánek M, Jupiter JB. History of operative treatment of forearm diaphyseal fractures. J Hand Surg Am. 2014 Feb;39(2):335-42. doi: 10.1016/j.jhsa.2013.06.020. Epub 2013 Dec 11. — View Citation

Hardy BT, Glowczewskie F Jr, Wright TW. Vascular anatomy of the proximal ulna. J Hand Surg Am. 2011 May;36(5):808-10. doi: 10.1016/j.jhsa.2011.02.011. Epub 2011 Apr 12. — View Citation

Kloen P, Buijze GA, Ring D. Management of forearm nonunions: current concepts. Strategies Trauma Limb Reconstr. 2012 Apr;7(1):1-11. doi: 10.1007/s11751-011-0125-0. Epub 2011 Nov 24. — View Citation

Kloen P, Wiggers JK, Buijze GA. Treatment of diaphyseal non-unions of the ulna and radius. Arch Orthop Trauma Surg. 2010 Dec;130(12):1439-45. doi: 10.1007/s00402-010-1071-x. Epub 2010 Mar 9. — View Citation

Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avascular areas in anatomical study	The extraossea and intraossea vascularity of the forearms with Spalteholz dissection technique and Tompsett dissection technique will be described. The location, distribution and dimensions of the vessels and the areas without vascularity will be measured with a digital caliper (mm).	8 months
Primary	Epidemiological risk factors for ulnar nonunion	Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.	8 months
Primary	Biomechanical risk factors for ulnar nonunion	Biomechanical risk factors will be evaluated using the OTA/AO classification.	8 months