Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Not Applicable

Terminated

• Conditions: Humeral Diaphysis Fracture
• Interventions: Procedure: Plate and screws or nailing; Device: Hanging Support System (HSS) brace

• Registration Number: NCT01116349
• Lead Sponsor: Hopital de l'Enfant-Jesus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Plate and screws or nailing	Patients included in the surgical group will have surgery to treat the fracture.
Conservative treatment group	Hanging Support System (HSS) brace	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.

Primary Outcome Measures

Name	Time	Method
Function and quality of life on DASH scale	6 months after treatment	The function and quality of life are measured using the DASH scale six months after treatment.

Secondary Outcome Measures

Name	Time	Method
DASH score	12 months after treatment	The function and quality of life are measured using the DASH scale 12 months after treatment.
Return to professional activities	3 months after treatment	It will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
SF-36 score	12 months after treatment	This score will help validate the impact on quality of life of both types of treatment. It includes 36 items asking about the recent quality of life. This will also enable better understanding of the impact in real time on the functional level.
Proportion of additional surgeries	12 months after surgery	The evaluation of the rate of complications such as infection, implant removal, non-union, implant failure or malunion which necessitate additional surgery.
Radiological loss of reduction	6 months after treatment	The main observed displacements occur in varus and are measured on an AP view of the humerus. Initial displacements are tolerated up to 20 degrees in varus and in flexion.; We measure the proportion of patients who experienced worsening of the deformity of more than 5 degrees on both levels.
Union rate	6 months after treatment	The union is defined by the presence of a strong radiological callus associated with lack of pain at the fracture site. The humerus unifies in an average of three months. It is considered non-union if it is not unified after six months, and it is classified as delayed union between 3 and 6 months.; The rates will be presented by the number of patients with non-union in each group.
Rates of complication	within the first year following treatment	The main complications recognized in the treatment of humerus fractures are: infection, nerve damage, malunion and non-unions. Each complication will be recorded and reported.
Pain on visual analogue pain scale (VAS)	2 weeks after treatment	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Pain on VAS	12 months after treatment	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Measurement of range of motion of the shoulder	12 months after treatment	Using a goniometer, we will measure the bending (normal value 180 °), abduction (180°), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60°).
Measurement of range of motion of the elbow	12 months after treatment	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).

Trial Locations

Locations (2)

Hôpital l'Enfant-Jésus; 🇨🇦 Quebec, Canada

CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada