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the number of patients was not sufficient to support continuation of the study
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This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle
The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| evaluation of clinical and radiographic findings after surgical treatment | Experimental | Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pseudoarthrosis of clavicle | Procedure | Pseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments. |
| Measure | Description | Time Frame |
|---|---|---|
| range of motion ROM | improvement of range of motion measure (in grade) | at least 1 year of follow up |
| presence of dyskinesias | objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points) | at least 1 year of follow up |
| alteration of the clavicle length | measure (mm) obtained from radiographic evaluation | at least 1 year of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate shoulder function | improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points) | at least 1 year of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| C562548 | Clavicle, Pseudarthrosis Of, Congenital |
| D011542 | Pseudarthrosis |
| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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interventional study
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