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Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

Primary Purpose

Humeral Diaphysis Fracture

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Plate and screws or nailing
Hanging Support System (HSS) brace
Sponsored by
Hopital de l'Enfant-Jesus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Diaphysis Fracture focused on measuring humeral diaphysis fracture, plate and screws for humeral diaphysis fracture, nailing for humerus diaphysis fracture, Hanging Support System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHA-Pavillon Enfant-Jésus
  • Hôpital l'Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical treatment

Conservative treatment group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

DASH score
The function and quality of life are measured using the DASH scale 6 months after treatment.
Return to professional activities
It will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
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.
DASH score
The function and quality of life are measured using the DASH scale 12 months after treatment.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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°).
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°).
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°).
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°).
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°).
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 °).
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 °).
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 °).
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 °).
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 °).

Full Information

First Posted
May 3, 2010
Last Updated
December 19, 2012
Sponsor
Hopital de l'Enfant-Jesus
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1. Study Identification

Unique Protocol Identification Number
NCT01116349
Brief Title
Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
Official Title
Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Difficulties to recruit participants A similar Canadian multicentric study started at about the same.
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital de l'Enfant-Jesus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Diaphysis Fracture
Keywords
humeral diaphysis fracture, plate and screws for humeral diaphysis fracture, nailing for humerus diaphysis fracture, Hanging Support System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Patients included in the surgical group will have surgery to treat the fracture.
Arm Title
Conservative treatment group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Plate and screws or nailing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hanging Support System (HSS) brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Function and quality of life on DASH scale
Description
The function and quality of life are measured using the DASH scale six months after treatment.
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
DASH score
Description
The function and quality of life are measured using the DASH scale 6 months after treatment.
Time Frame
6 months after treatment
Title
Return to professional activities
Description
It will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
Time Frame
3 months after treatment
Title
SF-36 score
Description
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.
Time Frame
6 months after treatment
Title
DASH score
Description
The function and quality of life are measured using the DASH scale 12 months after treatment.
Time Frame
12 months after treatment
Title
SF-36 score
Description
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.
Time Frame
12 months after treatment
Title
Proportion of additional surgeries
Description
The evaluation of the rate of complications such as infection, implant removal, non-union, implant failure or malunion which necessitate additional surgery.
Time Frame
12 months after surgery
Title
Radiological loss of reduction
Description
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.
Time Frame
2 weeks after treatment
Title
Radiological loss of reduction
Description
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.
Time Frame
6 weeks after treatment
Title
Radiological loss of reduction
Description
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.
Time Frame
12 weeks after treatment
Title
Radiological loss of reduction
Description
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.
Time Frame
6 months after treatment
Title
Union rate
Description
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.
Time Frame
12 weeks after treatment
Title
Union rate
Description
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.
Time Frame
6 months after treatment
Title
Rates of complication
Description
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.
Time Frame
within the first year following treatment
Title
Pain on visual analogue pain scale (VAS)
Description
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Time Frame
2 weeks after treatment
Title
Pain on VAS
Description
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Time Frame
6 weeks after treatment
Title
Pain on VAS
Description
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Time Frame
12 weeks after treatment
Title
Pain on VAS
Description
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Time Frame
6 months after treatment
Title
Pain on VAS
Description
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full of numbers 1 to 10.
Time Frame
12 months after treatment
Title
Measurement of range of motion of the shoulder
Description
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°).
Time Frame
2 weeks after treatment
Title
Measurement of range of motion of the shoulder
Description
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°).
Time Frame
6 weeks after treatment
Title
Measurement of range of motion of the shoulder
Description
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°).
Time Frame
12 weeks after treatment
Title
Measurement of range of motion of the shoulder
Description
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°).
Time Frame
6 months after treatment
Title
Measurement of range of motion of the shoulder
Description
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°).
Time Frame
12 months after treatment
Title
Measurement of range of motion of the elbow
Description
Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).
Time Frame
2 weeks after treatment
Title
Measurement of range of motion of the elbow
Description
Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).
Time Frame
6 weeks after treatment
Title
Measurement of range of motion of the elbow
Description
Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).
Time Frame
12 weeks after treatment
Title
Measurement of range of motion of the elbow
Description
Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).
Time Frame
6 months after treatment
Title
Measurement of range of motion of the elbow
Description
Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).
Time Frame
12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Pelet, MD, PhD
Organizational Affiliation
Hôpital de l'Enfant-Jésus
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA-Pavillon Enfant-Jésus
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Hôpital l'Enfant-Jésus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

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