Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Study Overview
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Brief Summary
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The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function. The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.

Official Title
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Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study

Conditions
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Fracture of Proximal Humerus

Intervention / Treatment
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* Device: PHILOS™ locked plate system by Synthes Canada©
* Other: Early and intensive exercise program
* Other: Standard rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years Unstable fracture of the proximal humerus Two-part and three-part fractures according to the Neer classification Closed fracture Time between trauma and surgery less than or equal to 7 days Signing of consent form Exclusion Criteria: Stable fracture of the proximal humerus (not requiring surgery) Four-part fracture on the Neer classification Fracture-dislocation or fracture involving the articular surface Isolated fracture of the large or small tuberosity Pathological fracture Fracture associated with neuro-vascular lesions Bilateral fractures Fracture associated with long bones fracture Polytrauma Previous history of fracture or surgery to the ipsilateral proximal humerus Severe COPD Severe neuromuscular disorders (Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...) Remote location of patient's home which makes it difficult to come to facility for follow-up visits Any medical condition making it impossible for the patient to perform the exercise program (Alzheimer, dementia, etc. ...) Man or woman incapacitated sign consent form Any other condition which prevents the assessor from fully monitoring the patient during study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive Rehabilitation<br> | Device: PHILOS™ locked plate system by Synthes Canada©<br>* The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.<br>Other: Early and intensive exercise program<br>* A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation program without physical therapy. The exercise program will be provided to the patient. The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0 °. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full program will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist. The patient will complete a daily diary to validate the frequency and intensity of the exercises.<br>|
| Active Comparator: Standard Rehabilitation<br> | Device: PHILOS™ locked plate system by Synthes Canada©<br>* The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.<br>Other: Standard rehabilitation program<br>* The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise program, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome on Constant score | The investigators will validate that early and intensive rehabilitation gives a better functional outcome at 6 months using the Constant score adjusted for age. A difference of 10 points is considered significant (standard deviation of 15 points). | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of reoperation | The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery. | within the first year following surgery | 
| Loss of radiological reduction | The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique. | 1 or 2 days after surgery | 
| Loss of radiological reduction | The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique | 10-14 days after surgery | 
| Loss of radiological reduction | The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique | 3 or 4 months after surgery | 
| Loss of radiological reduction | The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique | 6 months after surgery | 
| Loss of radiological reduction | The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique | 12 months after surgery | 
| Sustainability of the efficacy on Constant score | Constant score will be measured one year after surgery to demonstrate the sustainability of the efficacy of intensive rehabilitation. | 12 months after surgery | 
| Quality of life on DASH scale | The quality of life is measured using the DASH scale 3 months after surgery. | 3 months after surgery | 
| Quality of life on DASH scale | Quality of life is measured using the DASH scale 6 months after surgery. | 6 months after surgery | 
| Quality of life on DASH scale | Quality of life is measured using the DASH scale 12 months after surgery. | 12 months after surgery | 
| Return to professional activities | This will be determined in days after surgery, to rates of 50% and 100% of the usual workload. | 3 or 4 months after surgery | 
| Pain on visual analog scale (VAS) | The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS. | 10-14 days after surgery | 
| Pain on VAS | The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS. | 3 or 4 months after surgery | 
| Pain on VAS | The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS. | 6 months after surgery | 
| Pain on VAS | The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS. | 12 months after surgery | 
| Measurement of range of motion of shoulder | Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °). | 3 months after surgery | 
| Measurement of range of motion of shoulder | Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °). | 6 months after surgery | 
| Measurement of range of motion of shoulder | Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °). | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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humerus fracture, locked plate