Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Humeral Diaphysis Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01116349
• Other study ID #: PEJ-530
• Status: Terminated
• Phase: N/A
• First received: May 3, 2010
• Last updated: December 19, 2012
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: December 2012
• Source: Hopital de l'Enfant-Jesus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Diaphysis Fracture

Intervention

Procedure:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Canada	Hôpital l'Enfant-Jésus	Quebec
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function and quality of life on DASH scale	The function and quality of life are measured using the DASH scale six months after treatment.	6 months after treatment	No
Secondary	DASH score	The function and quality of life are measured using the DASH scale 6 months after treatment.	6 months after treatment	No
Secondary	Return to professional activities	It will be determined in days after surgery, to rates of 50% and 100% of the usual workload.	3 months after treatment	No
Secondary	SF-36 score	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.	6 months after treatment	No
Secondary	DASH score	The function and quality of life are measured using the DASH scale 12 months after treatment.	12 months after treatment	No
Secondary	SF-36 score	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.	12 months after treatment	No
Secondary	Proportion of additional surgeries	The evaluation of the rate of complications such as infection, implant removal, non-union, implant failure or malunion which necessitate additional surgery.	12 months after surgery	No
Secondary	Radiological loss of reduction	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.	2 weeks after treatment	No
Secondary	Radiological loss of reduction	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.	6 weeks after treatment	No
Secondary	Radiological loss of reduction	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.	12 weeks after treatment	No
Secondary	Radiological loss of reduction	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.	6 months after treatment	No
Secondary	Union rate	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.	12 weeks after treatment	No
Secondary	Union rate	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.	6 months after treatment	No
Secondary	Rates of complication	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.	within the first year following treatment	No
Secondary	Pain on visual analogue pain scale (VAS)	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.	2 weeks after treatment	No
Secondary	Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.	6 weeks after treatment	No
Secondary	Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.	12 weeks after treatment	No
Secondary	Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.	6 months after treatment	No
Secondary	Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.	12 months after treatment	No
Secondary	Measurement of range of motion of the shoulder	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°).	2 weeks after treatment	No
Secondary	Measurement of range of motion of the shoulder	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°).	6 weeks after treatment	No
Secondary	Measurement of range of motion of the shoulder	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°).	12 weeks after treatment	No
Secondary	Measurement of range of motion of the shoulder	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°).	6 months after treatment	No
Secondary	Measurement of range of motion of the shoulder	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°).	12 months after treatment	No
Secondary	Measurement of range of motion of the elbow	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).	2 weeks after treatment	No
Secondary	Measurement of range of motion of the elbow	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).	6 weeks after treatment	No
Secondary	Measurement of range of motion of the elbow	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).	12 weeks after treatment	No
Secondary	Measurement of range of motion of the elbow	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).	6 months after treatment	No
Secondary	Measurement of range of motion of the elbow	Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).	12 months after treatment	No