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Trial record 1 of 1 for:    NCT02362100 | Ottawa, Canada
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Proximal Humerus Fractures Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT02362100
Recruitment Status : Recruiting
First Posted : February 12, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Secondary outcomes will include an assessment of the ASES score, the SF-36 quality of life score, complication rates, re-operation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or posttraumatic osteoarthritis .

Condition or disease Intervention/treatment Phase
Proximal Humerus Fracture Other: Non operative Procedure: locking plate surgical fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proximal Humerus Fractures Randomized Control Trial
Study Start Date : September 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: nonoperative management

Treatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows:

  • 0 - 3 weeks: immobilization with a shoulder sling, range of motion of elbow, hand and wrist
  • 3 - 6 weeks: same as 0-3 weeks, with addition of pendulum exercises every two hours
  • After 6 weeks: Active mobilization and removal of sling. Light activity permitted and physiotherapy for range of motion permitted as tolerated.
  • After 6 months: no further restriction will be placed. Full home and work activity permitted.
Other: Non operative
non operative treatment

Active Comparator: locking plate surgical fixation

Standardized operative management protocol as follows:

  • Pre-operative medical clearance established via anesthesia consults if required for medically complex patients.
  • Provision of pre-operative intravenous (IV) antibiotic prophylaxis:
  • Administration of general anesthetic.
  • Patient positioning and preparation:

    • Patient is carefully placed in the beach-chair position,
    • Deltopectoral approach Fracture reduction and fixation with confirmation with intraoperative fluoroscopy images.
Procedure: locking plate surgical fixation



Primary Outcome Measures :
  1. Constant shoulder score [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment [ Time Frame: 2 year ]
  2. SF36 short form [ Time Frame: 2 year ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Displaced 2- or 3-part proximal humerus fractures by the Neer classification.
  2. Displaced 4-part proximal humeral fractures by the Neer classification that are deemed amenable to surgical fixation.
  3. > 60 years of age
  4. Low energy mechanism of injury
  5. Acute fracture (<3 weeks)

Exclusion Criteria:

  1. 4-part proximal humerus fractures that are not deemed amenable to surgical fixation (eg. due to osteopenic bone, thin head or tuberosity fragments); fractures that are better suited to treatment with arthroplasty
  2. Isolated greater tuberosity fractures
  3. Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
  4. Open fracture
  5. Previous ipsilateral shoulder surgery
  6. Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
  7. Active joint or systemic infection
  8. Patients with convulsive disorders, collagen diseases, and any other conditions that might affect the mobility of the shoulder joint
  9. Major medical illness (life expectancy less than 2 years, unacceptably high operative risk, or not medically cleared by preoperative anesthesia consult)
  10. Unable to speak or read English/French
  11. Psychiatric illness that precludes informed consent
  12. Unwilling to be followed for 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362100


Contacts
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Contact: Peter Lapner, MD 613-737-8899 ext 78377 plapner@toh.on.ca

Locations
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Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Peter Lapner    613-798-5555    plapner@ottawahospital.on.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02362100     History of Changes
Other Study ID Numbers: 20150458-01H
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries