An interventional study of PHILOS™ locked plate system by Synthes Canada© and Early and intensive exercise program in Fracture of Proximal Humerus, sponsored by Hopital de l'Enfant-Jesus. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-20.
Sponsored by Hopital de l'Enfant-Jesus · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 80 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hopital de l'Enfant-Jesus is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: PHILOS™ locked plate system by Synthes Canada© · Other: Early and intensive exercise program
Device: PHILOS™ locked plate system by Synthes Canada© · Other: Standard rehabilitation program
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.
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.
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.
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).
Time frame: 6 months after surgery
Proportion of reoperation
The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 months after surgery
Quality of life on DASH scale
The quality of life is measured using the DASH scale 3 months after surgery.
Time frame: 3 months after surgery
Quality of life on DASH scale
Quality of life is measured using the DASH scale 6 months after surgery.
Time frame: 6 months after surgery
Quality of life on DASH scale
Quality of life is measured using the DASH scale 12 months after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 °).
Time frame: 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 °).
Time frame: 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 °).
Time frame: 12 months after surgery
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Hopital de l'Enfant-Jesus