NCT01113411

Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hopital de l'Enfant-Jesus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fracture of Proximal Humerus

Interventions

Type	Name	Description
DEVICE	PHILOS™ locked plate system by Synthes Canada©	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.
OTHER	Early and intensive exercise program	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.
OTHER	Standard rehabilitation program	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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-04-29
• Last updated: 2012-12-20

Locations

1 site across 1 country: Canada