Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Hopital de l'Enfant-Jesus

Status: Unknown

Conditions: Fracture of Proximal Humerus

Treatments: Other: Standard rehabilitation program; Other: Early and intensive exercise program; Device: PHILOS™ locked plate system by Synthes Canada©

Study type: Interventional

Funder types: Other

Identifiers

NCT01113411

PEJ-525

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intensive Rehabilitation

Active Comparator group

Treatment:

Other: Early and intensive exercise program

Device: PHILOS™ locked plate system by Synthes Canada©

Standard Rehabilitation

Active Comparator group

Treatment:

Other: Standard rehabilitation program

Device: PHILOS™ locked plate system by Synthes Canada©