Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft

Study Overview
=================
Brief Summary
-----------------
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Detailed Description
-----------------
From Jane 2015 to October 2016, patients with displaced humeral shaft fractures are retrospectively included in this study, they were treated with either operative plate or conservative treatment. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(DASH score) between the 2 groups at 1 year after surgery.

Official Title
-----------------
Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft

Conditions
-----------------
Humeral Fractures

Intervention / Treatment
-----------------
* Procedure: Conservative Treatment
* Procedure: Operative Plate Fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury Provision of informed consent Exclusion Criteria: Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative Treatment<br>Standard protocol for conservative treatment will consist of the implementation of a sling and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon. | Procedure: Conservative Treatment<br>* Conservative Treatment<br>|
| Operative Plate Fixation<br>The operating surgeon will determine the positioning of the patient for surgery. ORIF of the humeral shaft fracture will be carried out | Procedure: Operative Plate Fixation<br>* Operative Plate Fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union rate | Union rate of the fracture from X-ray | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score | DASH score of the injured arm | 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humeral Fractures, plate, Conservative Treatment