Vascularity of the Ulna and Its Association With Forearm Nonunion

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT03805204
Collaborator
(none)
211
1
32.9
6.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Open reduction and internal fixation (ORIF)

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 Design

Study Type:
Observational
Actual Enrollment :
211 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Anatomical Study About the Vascularization of the Ulna: Vascular and Mechanical Risk Factors Associated With Forearm Nonunion
Actual Study Start Date :
Dec 3, 2018
Actual Primary Completion Date :
Jul 29, 2021
Actual Study Completion Date :
Aug 30, 2021

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Epidemiological risk factors for ulnar nonunion [8 months]

    Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.

  3. Biomechanical risk factors for ulnar nonunion [8 months]

    Biomechanical risk factors will be evaluated using the OTA/AO classification.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults from 18 to 90 years old

  • Forearm ulnar nonunion

Exclusion Criteria:
  • Children

  • Other types of forearm fractures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

Sponsors and Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Claudia Lamas, Ph D, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT03805204
Other Study ID Numbers:
  • IIBSP-CUB-2018-61
First Posted:
Jan 15, 2019
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 26, 2021