Vascularity of the Ulna and Its Association With Forearm Nonunion

Completed

• Conditions: Forearm Fracture

• Registration Number: NCT03805204
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Primary Completion: 2021-07-29
• Study Completion: 2021-08-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• Adults from 18 to 90 years old
• Forearm ulnar nonunion

Exclusion Criteria

• Children
• Other types of forearm fractures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Avascular areas in anatomical study	8 months	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).
Epidemiological risk factors for ulnar nonunion	8 months	Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.
Biomechanical risk factors for ulnar nonunion	8 months	Biomechanical risk factors will be evaluated using the OTA/AO classification.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain