- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06360848
Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
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
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00001192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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