Surgical Innovations in Treatment of Clavicle Fractures

Study Overview
=================
Brief Summary
-----------------
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm. The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.

Detailed Description
-----------------
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm. The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a prospective observational protocol was chosen.

Official Title
-----------------
Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle

Conditions
-----------------
Complication

Intervention / Treatment
-----------------
* Procedure: conventional plate osteosynthesis
* Procedure: mini-incision-type osteosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent Exclusion Criteria: all other patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional plate osteosynthesis<br>Standard procedure | Procedure: conventional plate osteosynthesis<br>* Standard incision<br>|
| Active Comparator: mini-incision-type osteosynthesis<br>mini-incision | Procedure: mini-incision-type osteosynthesis<br>* Mini-incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area of paresthetic skin |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fracture healing |  | 12 month | 
| Postoperative shoulder function |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clavicle, surgical intervention, mini-incision, plate osteosynthesis