Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Humeral Diaphysis Fracture
- Sponsor
- Hopital de l'Enfant-Jesus
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Function and quality of life on DASH scale
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The conservative treatment of diaphyseal fractures of the humerus has long been considered the only option and the surgical treatment was primarily reserved for displaced fractures with no contact of bone ends. However, for a few years there has been an upsurge of indications for the surgical treatment of diaphyseal fractures.
The purpose of this study is to compare the functional outcomes and the quality of life of surgically treated patients versus those who undergo a conservative treatment.
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
- •Fracture of the humeral diaphysis
- •Recent fracture (14 days or less)
- •Closed fracture
- •Signing of consent form
Exclusion Criteria
- •Segmental fracture of the humerus
- •Fracture with proximal or distal intra articular extension
- •Open fracture
- •Polytrauma
- •Floating elbow or shoulder
- •Pathological fracture
- •Simultaneous fracture of both humerus
- •Associated vascular disease
- •Severe neuromuscular disorders such as Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...
- •medical contraindication to surgery
Outcomes
Primary Outcomes
Function and quality of life on DASH scale
Time Frame: 6 months after treatment
The function and quality of life are measured using the DASH scale six months after treatment.
Secondary Outcomes
- DASH score(12 months after treatment)
- Return to professional activities(3 months after treatment)
- SF-36 score(12 months after treatment)
- Proportion of additional surgeries(12 months after surgery)
- Radiological loss of reduction(6 months after treatment)
- Union rate(6 months after treatment)
- Rates of complication(within the first year following treatment)
- Pain on visual analogue pain scale (VAS)(2 weeks after treatment)
- Pain on VAS(12 months after treatment)
- Measurement of range of motion of the shoulder(12 months after treatment)
- Measurement of range of motion of the elbow(12 months after treatment)