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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Rehabilitation | Active Comparator |
| |
| Standard Rehabilitation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHILOS™ locked plate system by Synthes Canada© | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène Côté, Reg. Nurse | Contact | 1-418-649-0252 | 3165 | helco3@hotmail.com |
| Stéphane Pelet, MD, PhD | Contact | 1-418-649-0252 | 3165 | stephane.pelet.ortho@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane Pelet, MD, PhD | Hôpital Enfant-Jésus | Principal Investigator |
| Annie Arteau, MD | Hôpital Enfant-Jésus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA-Pavillon Enfant-Jésus | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
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| Early and intensive exercise program | Other | 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. |
|
| Standard rehabilitation program | Other | 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. |
|
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 |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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