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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06360848
Other study ID # IRB00001192
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2005
Est. completion date January 1, 2021

Study information

Verified date April 2024
Source Ibn Jazzar Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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++).


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
surgery
SURGICAL TREATMENT OF PSEUDARTHROSIS OF THE HUMERUS

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ibn Jazzar Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) Surgical technique Screwed plate:5 Percutaneous pinning:12 a minimum follow-up of 10
Primary Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) Surgical technique Screwed plate:4 Percutaneous pinning:9 a minimum follow-up of 10 months
Primary Time to consolidation depending on the type of pseudarthrosis (in 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
Primary Average Constant score postoperatively according to the means of restraint Screwed plate(24) :74 External fixator(28) :64 Nailing centromedullary(1) :69 a minimum follow-up of 10 months
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