Clinical Trials Directory

Trials / Terminated

TerminatedNCT01116349

Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Hopital de l'Enfant-Jesus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPlate and screws or nailingPatients 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.
DEVICEHanging Support System (HSS) bracePatients 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.

Timeline

Start date
2010-01-01
Primary completion
2012-12-01
Completion
2014-07-01
First posted
2010-05-05
Last updated
2012-12-20

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT01116349. Inclusion in this directory is not an endorsement.