Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws

Study Overview
=================
Brief Summary
-----------------
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle

Detailed Description
-----------------
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

Official Title
-----------------
Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws

Conditions
-----------------
Pseudoarthrosis of the Clavicle

Intervention / Treatment
-----------------
* Procedure: pseudoarthrosis of clavicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of pseudarthrosis intervention Males and Females Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute Exclusion Criteria: Floating shoulder subjects who present contraindications to radiographic examination at the time of telephone contact

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: evaluation of clinical and radiographic findings after surgical treatment<br>Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle | Procedure: pseudoarthrosis of clavicle<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pseudoarthrosis, clavicle