Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fracture of Proximal Humerus
- Sponsor
- Hopital de l'Enfant-Jesus
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Functional outcome on Constant score
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus
Eligibility Criteria
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
Outcomes
Primary Outcomes
Functional outcome on Constant score
Time Frame: 6 months after surgery
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).
Secondary Outcomes
- Proportion of reoperation(within the first year following surgery)
- Loss of radiological reduction(12 months after surgery)
- Sustainability of the efficacy on Constant score(12 months after surgery)
- Quality of life on DASH scale(12 months after surgery)
- Return to professional activities(3 or 4 months after surgery)
- Pain on visual analog scale (VAS)(10-14 days after surgery)
- Pain on VAS(12 months after surgery)
- Measurement of range of motion of shoulder(12 months after surgery)