Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)

April 8, 2024 updated by: Zied Mansi, Ibn Jazzar Hospital

Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.

The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The management of pseudarthrosis of the humerus remains a subject of controversy. Given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with Ilizarov is most appropriate in septic pseudarthrosis.

However, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).

Study Type

Observational

Enrollment (Actual)

53

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

53 cases. of pseudarthrosis of the humeral shaft collected at the surgery department orthopedic and traumatology

Description

Inclusion Criteria:

  • - Adult men and women > 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.

Exclusion Criteria:

  • - Unusable files.
  • Patients lost to follow-up.
  • Patients who did not accept therapeutic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
Time Frame: a minimum follow-up of 10
Surgical technique Screwed plate:5 Percutaneous pinning:12
a minimum follow-up of 10
Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
Time Frame: a minimum follow-up of 10 months
Surgical technique Screwed plate:4 Percutaneous pinning:9
a minimum follow-up of 10 months
Time to consolidation depending on the type of pseudarthrosis (in months)
Time Frame: a minimum follow-up of 10 months
Atrophic Pseudarthrosis 4.4 months Pseudarthrosis Aseptic 5.28 months Hypertrophic Pseudarthrosis 5.8 months Septic Pseudarthrosis 4.6 months
a minimum follow-up of 10 months
Average Constant score postoperatively according to the means of restraint
Time Frame: a minimum follow-up of 10 months
Screwed plate(24) :74 External fixator(28) :64 Nailing centromedullary(1) :69
a minimum follow-up of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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