Clinical Trials Directory

Trials / Completed

CompletedNCT03805204

Vascularity of the Ulna and Its Association With Forearm Nonunion

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

Status
Completed
Phase
Study type
Observational
Enrollment
211 (actual)
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOpen reduction and internal fixation (ORIF)ORIF with a forearm plate

Timeline

Start date
2018-12-03
Primary completion
2021-07-29
Completion
2021-08-30
First posted
2019-01-15
Last updated
2021-10-26

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03805204. Inclusion in this directory is not an endorsement.