Clinical trial NCT01116349: Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
Official title: Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Humeral Diaphysis Fracture
Keywords: humeral diaphysis fracture
plate and screws for humeral diaphysis fracture
nailing for humerus diaphysis fracture
Hanging Support System
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* severe central neurological disease disabling patient to fill in questionnaires (senile dementia, Alzheimer's, etc ...
* Male or female unable to consent
* Any other condition which prevents the assessor from fully monitoring the patient during study

Primary outcomes:
measure: Function and quality of life on DASH scale
timeFrame: 6 months after treatment
Secondary outcomes:
measure: DASH score
timeFrame: 6 months after treatment
measure: Return to professional activities
timeFrame: 3 months after treatment
measure: SF-36 score
timeFrame: 6 months after treatment
measure: DASH score
timeFrame: 12 months after treatment
measure: SF-36 score
timeFrame: 12 months after treatment
measure: Proportion of additional surgeries
timeFrame: 12 months after surgery
measure: Radiological loss of reduction
timeFrame: 2 weeks after treatment
measure: Radiological loss of reduction
timeFrame: 6 weeks after treatment
measure: Radiological loss of reduction
timeFrame: 12 weeks after treatment
measure: Radiological loss of reduction
timeFrame: 6 months after treatment
measure: Union rate
timeFrame: 12 weeks after treatment
measure: Union rate
timeFrame: 6 months after treatment
measure: Rates of complication
timeFrame: within the first year following treatment
measure: Pain on visual analogue pain scale (VAS)
timeFrame: 2 weeks after treatment
measure: Pain on VAS
timeFrame: 6 weeks after treatment
measure: Pain on VAS
timeFrame: 12 weeks after treatment
measure: Pain on VAS
timeFrame: 6 months after treatment
measure: Pain on VAS
timeFrame: 12 months after treatment
measure: Measurement of range of motion of the shoulder
timeFrame: 2 weeks after treatment
measure: Measurement of range of motion of the shoulder
timeFrame: 6 weeks after treatment
measure: Measurement of range of motion of the shoulder
timeFrame: 12 weeks after treatment
measure: Measurement of range of motion of the shoulder
timeFrame: 6 months after treatment
measure: Measurement of range of motion of the shoulder
timeFrame: 12 months after treatment
measure: Measurement of range of motion of the elbow
timeFrame: 2 weeks after treatment
measure: Measurement of range of motion of the elbow
timeFrame: 6 weeks after treatment
measure: Measurement of range of motion of the elbow
timeFrame: 12 weeks after treatment
measure: Measurement of range of motion of the elbow
timeFrame: 6 months after treatment
measure: Measurement of range of motion of the elbow
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
city: Quebec
country: Canada
facility: Hôpital l'Enfant-Jésus
Study officials:
affiliation: Hôpital de l'Enfant-Jésus
name: Stéphane Pelet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: