Study Stopped
Difficulties to recruit participants A similar Canadian multicentric study started at about the same.
Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
1 other identifier
interventional
4
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedDecember 20, 2012
December 1, 2012
2.9 years
May 3, 2010
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (28)
DASH score
6 months after treatment
Return to professional activities
3 months after treatment
SF-36 score
6 months after treatment
DASH score
12 months after treatment
SF-36 score
12 months after treatment
- +23 more secondary outcomes
Study Arms (2)
Surgical treatment
ACTIVE COMPARATORPatients included in the surgical group will have surgery to treat the fracture.
Conservative treatment group
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female over 18 years
- Fracture of the humeral diaphysis
- Recent fracture (14 days or less)
- Closed fracture
- Signing of consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Hôpital l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Pelet, MD, PhD
Hôpital de l'Enfant-Jésus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Stephane Pelet MD, PhD Orthopedic surgeon
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 5, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
July 1, 2014
Last Updated
December 20, 2012
Record last verified: 2012-12