Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus

This study has been terminated.
(Difficulties to recruit participants A similar Canadian multicentric study started at about the same.)
Sponsor:
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01116349
First received: May 3, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Humeral Diaphysis Fracture
Procedure: Plate and screws or nailing
Device: Hanging Support System (HSS) brace

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.

Resource links provided by NLM:


Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Function and quality of life on DASH scale [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    The function and quality of life are measured using the DASH scale six months after treatment.


Secondary Outcome Measures:
  • DASH score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    The function and quality of life are measured using the DASH scale 6 months after treatment.

  • Return to professional activities [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    It will be determined in days after surgery, to rates of 50% and 100% of the usual workload.

  • SF-36 score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    The function and quality of life are measured using the DASH scale 12 months after treatment.

  • SF-36 score [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: within the first year following treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    Using a goniometer, we will measure the bending (normal value 140 °), extension (normal value 0 °), pronation (normal value 80 °) and supination (normal value 80 °).


Enrollment: 4
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical treatment
Patients included in the surgical group will have surgery to treat the fracture.
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.
Active Comparator: Conservative treatment group
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116349

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
Canada
Hôpital l'Enfant-Jésus
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital de l'Enfant-Jésus
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01116349     History of Changes
Other Study ID Numbers: PEJ-530
Study First Received: May 3, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
humeral diaphysis fracture
plate and screws for humeral diaphysis fracture
nailing for humerus diaphysis fracture
Hanging Support System

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014