Humerus Fracture Clinical Trial
Official title:
Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
| 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 |
| Verified date | April 2024 |
| Source | Ibn Jazzar Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ibn Jazzar Hospital |
| 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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