Proximal Humerus Fractures Randomized Control Trial

May 14, 2021 updated by: Ottawa Hospital Research Institute
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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline to up until 24-Months Post-Operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to up until 24-Months Post-Operative
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.
From baseline to up until 24-Months Post-Operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Peter Lapner, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

February 8, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150458-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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