Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.

Detailed Description
-----------------
Different methods have been used in the treatment of proximal humeral fractures. Usually, treatment choice depends on fracture displacement, patient age, osteoporosis, and other characteristics. Locking plate fixation has become the most widely used method among surgical techniques, while partial arthroplasty is reserved for older patients and comminuted articular fractures. Generally, nonsurgical treatment involves a brief period with sling immobilization and physiotherapy rehabilitation. A recent multicenter study showed no difference between conservative and surgical treatments, including internal fixation with locking plates. Two other randomized studies showed mixed results, with no relevant clinical differences between the methods. No previous trial has evaluated the quality of reduction in surgically treated fractures and its relation to outcomes. Our study aims to compare both techniques with a detailed radiographic and tomographic evaluation, in elderly patients. We also aim to evaluate the influence of reduction and plate positioning on clinical outcomes. This is a single center trial, in which surgeries will be performed by only two experienced surgeons.

Official Title
-----------------
Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial

Conditions
-----------------
Shoulder Fractures

Intervention / Treatment
-----------------
* Procedure: Osteosynthesis with locking plate
* Procedure: Sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proximal humeral fractures, involving humeral head, with at least one of the following parameters: Head-shaft angle between 100-200° or >175° on coronal plane; Shaft translation (on coronal or sagittal plane) > 1cm; Tuberosity displacement > 0,5cm; Head shaft angulation >45° in axial or sagittal plane; Less then 30 days Exclusion Criteria: No contact between shaft and humeral head Head-shaft angle <100° on coronal plane Articular head fracture with displacement > 2mm Fracture-dislocation Bilateral fracture Open fracture Ipsilateral or contralateral superior limb fracture Pathological fracture (tumors or bone disease, except for osteoporosis) Previous rotator cuff complete tear Previous infection Neurological injury Previous shoulder surgery Inability to answer subjective scores

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locking plate<br>Surgical treatment with open reduction and osteosynthesis with locking plate | Procedure: Osteosynthesis with locking plate<br>* Open reduction and osteosynthesis with locking plate<br>|
| Active Comparator: Conservative<br>Conservative treatment with sling and rehabilitation | Procedure: Sling<br>* Conservative treatment with sling and rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual relative Constant-Murley score | Constant-Murley score relative to the unaffected shoulder | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Shoulder (ASES) score | Subjective functional evaluation | 2 years | 
| Constant-Murley score |  | 2 years | 
| 12-Item Short Form Health Survey (SF-12) | Quality of life evaluation | 2 years | 
| Visual analog scale (VAS) for pain |  | 2 years | 
| Complication and reoperation rate |  | 2 years | 
| Radiographic evaluation | Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria | 2 years | 
| Rotator cuff ultrasound and magnetic resonance |  | 2 years |