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Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures

Primary Purpose

Humeral Fracture, Proximal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Total Shoulder Arthroplasty
Hemiarthroplasty
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fracture, Proximal focused on measuring Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Displaced 3- or 4-part fracture of the proximal humerus
  • Age over 70 years
  • Independent living
  • Low energy trauma

Exclusion criteria

  • Pre-existing shoulder disease
  • Severe cognitive dysfunction
  • More than 14 days from injury to surgery
  • Comorbidity that affects shoulder rehabilitation considerably
  • Concurrent injury that affect shoulder rehabilitation considerably

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Reverse Total Shoulder Arthroplasty

    Hemiarthroplasty

    Arm Description

    Outcomes

    Primary Outcome Measures

    Constant-Murley Score
    The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.
    WOOS (Western Ontario Osteoarthritis of the Shoulder) Index

    Secondary Outcome Measures

    Full Information

    First Posted
    December 14, 2017
    Last Updated
    September 1, 2020
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03383991
    Brief Title
    Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
    Official Title
    Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 10, 2013 (Actual)
    Primary Completion Date
    September 2, 2020 (Actual)
    Study Completion Date
    September 2, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    5. Study Description

    Brief Summary
    Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty. The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Humeral Fracture, Proximal
    Keywords
    Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Reverse Total Shoulder Arthroplasty
    Arm Type
    Experimental
    Arm Title
    Hemiarthroplasty
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Reverse Total Shoulder Arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Hemiarthroplasty
    Primary Outcome Measure Information:
    Title
    Constant-Murley Score
    Description
    The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.
    Time Frame
    24 months
    Title
    WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Displaced 3- or 4-part fracture of the proximal humerus Age over 70 years Independent living Low energy trauma Exclusion criteria Pre-existing shoulder disease Severe cognitive dysfunction More than 14 days from injury to surgery Comorbidity that affects shoulder rehabilitation considerably Concurrent injury that affect shoulder rehabilitation considerably
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Per Olerud, MD
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carl Ekholm, MD
    Organizational Affiliation
    Sahlgrenska Academy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35727196
    Citation
    Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
    Results Reference
    derived

    Learn more about this trial

    Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures

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