Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
NCT ID: NCT01116349
Last Updated: 2012-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2010-01-31
2014-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgical treatment
Patients included in the surgical group will have surgery to treat the fracture.
Plate and screws or nailing
Patients included in the surgical group will be divided into two subgroups according to the method of fixation chosen: plate and screws or nailing. Surgeries take place under general anesthesia and a prophylaxis antibiotic is administrated. The installation and the approach will be chosen by the surgeon according to his preferences. A thoraco brachial brace is placed on the patient at the end of the intervention and it remains in place for a period of 5 to 10 days (patient comfort). A gradual mobilization of the elbow and shoulder will be initiated by the patient at home. The addition of physical therapy will be decided by the surgeon and noted down accordingly.
Conservative treatment group
Patients included in the conservative group will be taken to a plaster room where a Hanging Support System(HSS) brace will be installed by a qualified technician.
Hanging Support System (HSS) brace
Patients included in the conservative group will be taken to a plaster room where the HSS brace will be installed by a qualified technician. Advice will be provided for the care, personal hygiene and clothing. The brace will be kept for a period of 6 to 12 weeks depending on the degree of healing of fracture. The maintenance of the proximal part (Brace) may be recommended by the surgeon. The mobilization will begin with exercises at home and whether the patient does physical therapy or not is the surgeon's choice.
Interventions
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Plate and screws or nailing
Patients included in the surgical group will be divided into two subgroups according to the method of fixation chosen: plate and screws or nailing. Surgeries take place under general anesthesia and a prophylaxis antibiotic is administrated. The installation and the approach will be chosen by the surgeon according to his preferences. A thoraco brachial brace is placed on the patient at the end of the intervention and it remains in place for a period of 5 to 10 days (patient comfort). A gradual mobilization of the elbow and shoulder will be initiated by the patient at home. The addition of physical therapy will be decided by the surgeon and noted down accordingly.
Hanging Support System (HSS) brace
Patients included in the conservative group will be taken to a plaster room where the HSS brace will be installed by a qualified technician. Advice will be provided for the care, personal hygiene and clothing. The brace will be kept for a period of 6 to 12 weeks depending on the degree of healing of fracture. The maintenance of the proximal part (Brace) may be recommended by the surgeon. The mobilization will begin with exercises at home and whether the patient does physical therapy or not is the surgeon's choice.
Eligibility Criteria
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Inclusion Criteria
* Fracture of the humeral diaphysis
* Recent fracture (14 days or less)
* Closed fracture
* Signing of consent form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hopital de l'Enfant-Jesus
OTHER
Responsible Party
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Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Principal Investigators
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Stéphane Pelet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de l'Enfant-Jésus
Locations
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CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada
Hôpital l'Enfant-Jésus
Québec, Quebec, Canada
Countries
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Other Identifiers
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PEJ-530
Identifier Type: -
Identifier Source: org_study_id