The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

Study Overview
=================
Brief Summary
-----------------
Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares standard mobilisation versus immmediate mobilisation in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.

Official Title
-----------------
The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.

Conditions
-----------------
Humeral Fracture

Intervention / Treatment
-----------------
* Procedure: Immediate mobilisation after locking-plate osteosynthesis
* Procedure: Standard mobilisation after locking plate osteosynthesis
* Device: Osteosynthesis with a locking plate (Philos)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Surgery can be performed within 10 days of injury A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus Exclusion Criteria: Glenohumeral dislocation Fracture of the Tuberculum Minus Open fracture Additional fractures in the shoulder region Other injuries requiring surgical treatment Clinically significant injury of the brachial plexus or vasculature Pathological fracture associated with cancer History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc) Rheumatoid Arthritis in the shoulder requiring active treatment Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc) Unwillingness to accept some of the treatment options.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Immediate mobilisation<br> | Procedure: Immediate mobilisation after locking-plate osteosynthesis<br>* Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.<br>Device: Osteosynthesis with a locking plate (Philos)<br>* Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.<br>|
| Active Comparator: Standard mobilisation<br> | Procedure: Standard mobilisation after locking plate osteosynthesis<br>* Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.<br>Device: Osteosynthesis with a locking plate (Philos)<br>* Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 3 weeks | 
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 6 weeks | 
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 3 months | 
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 6 months | 
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 1 year | 
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score | subjective and objective shoulder score | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Simple Shoulder Test (SST) | another shoulder score | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Pain in rest and motion (2 different values) | Numeric rating scale 0-10 | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Subjective satisfaction | Patient reported, Numeric Rating Scale 0-10 | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Quality of Life | Using the 15D instrument | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Complications | Complications of surgery and postoperative phase | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locking Plate, Physiotherapy