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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362100
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : September 17, 2020
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

Detailed Description:

The design of this study is two-fold. The main study will be a prospective, single blind, randomized controlled trial (RCT). Patients will be randomized to either (1) non-operative treatment or (2) locking plate open reduction and internal fixation (ORIF).

The second component of this study will be a prospective, cohort study. This option will be presented to patients who do not want to enroll in the RCT because they prefer one treatment option over the other, and do not wish to be randomized to a treatment. Patients who choose either non-operative treatment or ORIF for their proximal humerus fracture will be followed for 2 years post injury.

Study Objectives:

Objective 1: Does a difference exist in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score over a 2-year follow-up period? Objective 2: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score, the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score, the International Physical Activity Questionnaire (IPAQ) for the elderly, and the EuroQol EQ-5D-5L Health Questionnaire Quality of Life (QoL) functional outcome score over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding (hematoma), reoperation rate, or hospital readmission over a 2-year follow-up period? Objective 3: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on radiographic outcomes including non-union, malunion, and joint arthrosis? Objective 4: Does the degree of initial displacement or angulation of the fracture fragments correlate with final functional outcome measures? Objective 5: Does the quality of the surgical reduction correlate with final functional outcome measures?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proximal Humerus Fractures Randomized Control Trial
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 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. Change in Constant Score [ Time Frame: From baseline to up until 24-Months Post-Operative ]
    The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).


Secondary Outcome Measures :
  1. Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment [ Time Frame: From baseline to up until 24-Months Post-Operative ]
    The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.

  2. Change in Short Form-36 [ Time Frame: From baseline to up until 24-Months Post-Operative ]
    The Short Form 36 (SF-36) is an outcome measure used to determine quality of life. This measure has 8 scaled scores, each question has equal weight and is then translated onto a scale graded from 0-100. A higher number indicates a better outcome.



Information from the National Library of Medicine

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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


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Peter Lapner, MD The Ottawa Hospital
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    
Other Study ID Numbers: 20150458-01H
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries