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Vascularity of the Ulna and Its Association With Forearm Nonunion (Nonunion)

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ClinicalTrials.gov Identifier: NCT03805204
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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
Forearm Fracture 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
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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 : December 3, 2018
Actual Primary Completion Date : July 29, 2021
Actual Study Completion Date : August 30, 2021
Groups and Cohorts
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Intervention Details:
  • Procedure: Open reduction and internal fixation (ORIF)
    ORIF with a forearm plate

Outcome Measures
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Primary Outcome Measures :
  1. Avascular areas in anatomical study [ Time Frame: 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 [ Time Frame: 8 months ]
    Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.

  3. Biomechanical risk factors for ulnar nonunion [ Time Frame: 8 months ]
    Biomechanical risk factors will be evaluated using the OTA/AO classification.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anatomical study: 14 upper extremities from the Department of Human Anatomy. Clinical study. Records about 211 ulnar fractures. We included only the fractures with the complication of ulnar nonunion.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Other types of forearm fractures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805204


Locations
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Spain
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
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Principal Investigator: Claudia Lamas, Ph D Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Publications:

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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: January 15, 2019    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: When we have the results we analyse the anatomical and clinical data and association with the differents risks factors in the Department of Statistics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No