Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Hopital de l'Enfant-Jesus

Status: Terminated

Conditions: Humeral Diaphysis Fracture

Treatments: Device: Hanging Support System (HSS) brace; Procedure: Plate and screws or nailing

Study type: Interventional

Funder types: Other

Identifiers

NCT01116349

PEJ-530

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Surgical treatment

Active Comparator group

Description:

Patients included in the surgical group will have surgery to treat the fracture.

Treatment:

Procedure: Plate and screws or nailing

Conservative treatment group

Active Comparator group

Description:

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.

Treatment:

Device: Hanging Support System (HSS) brace