Humeral Diaphysis FractureNCT01116349
Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
A study testing Plate and screws or nailing and Hanging Support System (HSS) brace in people with Humeral Diaphysis Fracture, run by Hopital de l'Enfant-Jesus at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Diaphysis Fracture
- What is being tested?
- Plate and screws or nailing and Hanging Support System (HSS) brace
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years
- Fracture of the humeral diaphysis
- Recent fracture (14 days or less)
- Closed fracture
- Signing of consent form
Who cannot join
- Segmental fracture of the humerus
- Fracture with proximal or distal intra articular extension
- Open fracture
- Polytrauma
- Floating elbow or shoulder
- Pathological fracture
Show all 13Show fewer
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4
Hôpital l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
About this study
Official title: Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
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
- Humeral Diaphysis Fracture
- Being tested
- Plate and screws or nailing, Hanging Support System (HSS) brace
- Keywords
- humeral diaphysis fracture, plate and screws for humeral diaphysis fracture, nailing for humerus diaphysis fracture, Hanging Support System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate and screws or nailingProcedure or surgery
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.
Hanging Support System (HSS) braceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Active comparator | Patients included in the surgical group will have surgery to treat the fracture. Receives: Procedure: Plate and screws or nailing |
| Conservative treatment group | Active comparator | 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. Receives: Device: Hanging Support System (HSS) brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function and quality of life on DASH scale
The function and quality of life are measured using the DASH scale six months after treatment.
Measured: 6 months after treatment
Secondary outcomes (28)
DASH score
The function and quality of life are measured using the DASH scale 6 months after treatment.
Measured: 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.
Measured: 3 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.
Measured: 6 months after treatment
DASH score
The function and quality of life are measured using the DASH scale 12 months after treatment.
Measured: 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.
Measured: 12 months after treatment
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.
Measured: 12 months after 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.
Measured: 2 weeks after treatment
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.
Measured: 6 weeks after treatment
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.
Measured: 12 weeks after treatment
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.
Measured: 6 months after treatment
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.
Measured: 12 weeks after treatment
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.
Measured: 6 months after treatment
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.
Measured: within the first year following treatment
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.
Measured: 2 weeks after treatment
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.
Measured: 6 weeks after treatment
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.
Measured: 12 weeks after treatment
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.
Measured: 6 months after treatment
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.
Measured: 12 months after treatment
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°).
Measured: 2 weeks after treatment
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°).
Measured: 6 weeks after treatment
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°).
Measured: 12 weeks after treatment
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°).
Measured: 6 months after treatment
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°).
Measured: 12 months after treatment
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 °).
Measured: 2 weeks after treatment
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 °).
Measured: 6 weeks after treatment
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 °).
Measured: 12 weeks after treatment
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 °).
Measured: 6 months after treatment
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 °).
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: Difficulties to recruit participants A similar Canadian multicentric study started at about the same.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Diaphysis FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital de l'Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116349
- Sponsor's protocol ID
- PEJ-530
- Status last verified
- Dec 2012
- First submitted
- 3 May 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
- ClinicalTrials.gov ID
- NCT01116349
- Acronym / sponsor ID
- PEJ-530
- Conditions
- Humeral Diaphysis Fracture
- Keywords
- humeral diaphysis fracture, plate and screws for humeral diaphysis fracture, nailing for humerus diaphysis fracture, Hanging Support System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties to recruit participants A similar Canadian multicentric study started at about the same.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: Plate and screws or nailingPatients included in the surgical group will have surgery to treat the fracture. |
| Conservative treatment group | Active comparator | Device: Hanging Support System (HSS) bracePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female over 18 years
- Fracture of the humeral diaphysis
- Recent fracture (14 days or less)
- Closed fracture
- Signing of consent form
Key exclusion criteria (13 listed)
- Segmental fracture of the humerus
- Fracture with proximal or distal intra articular extension
- Open fracture
- Polytrauma
- Floating elbow or shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plate 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. | Procedure or surgery | Surgical treatment |
| Hanging 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. | Device | Conservative treatment group |
Primary outcome
Function and quality of life on DASH scale
Time frame: 6 months after treatment
The function and quality of life are measured using the DASH scale six months after treatment.
28 secondary outcomes
DASH score
Time frame: 6 months after treatment
Return to professional activities
Time frame: 3 months after treatment
SF-36 score
Time frame: 6 months after treatment
DASH score
Time frame: 12 months after treatment
SF-36 score
Time frame: 12 months after treatment
Proportion of additional surgeries
Time frame: 12 months after surgery
Radiological loss of reduction
Time frame: 2 weeks after treatment
Radiological loss of reduction
Time frame: 6 weeks after treatment
Radiological loss of reduction
Time frame: 12 weeks after treatment
Radiological loss of reduction
Time frame: 6 months after treatment
Union rate
Time frame: 12 weeks after treatment
Union rate
Time frame: 6 months after treatment
Rates of complication
Time frame: within the first year following treatment
Pain on visual analogue pain scale (VAS)
Time frame: 2 weeks after treatment
Pain on VAS
Time frame: 6 weeks after treatment
Pain on VAS
Time frame: 12 weeks after treatment
Pain on VAS
Time frame: 6 months after treatment
Pain on VAS
Time frame: 12 months after treatment
Measurement of range of motion of the shoulder
Time frame: 2 weeks after treatment
Measurement of range of motion of the shoulder
Time frame: 6 weeks after treatment
Measurement of range of motion of the shoulder
Time frame: 12 weeks after treatment
Measurement of range of motion of the shoulder
Time frame: 6 months after treatment
Measurement of range of motion of the shoulder
Time frame: 12 months after treatment
Measurement of range of motion of the elbow
Time frame: 2 weeks after treatment
Measurement of range of motion of the elbow
Time frame: 6 weeks after treatment
Measurement of range of motion of the elbow
Time frame: 12 weeks after treatment
Measurement of range of motion of the elbow
Time frame: 6 months after treatment
Measurement of range of motion of the elbow
Time frame: 12 months after treatment
Results and safety
The study was stopped early (reason given: Difficulties to recruit participants A similar Canadian multicentric study started at about the same.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Pelet, MD, PhD principal investigator
Hôpital de l'Enfant-Jésus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plate and screws or nailing and Hanging Support System (HSS) brace in people with Humeral Diaphysis Fracture, run by Hopital de l'Enfant-Jesus at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties to recruit participants A similar Canadian multicentric study started at about the same.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function and quality of life on DASH scale (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.