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
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
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
NCT ID
NCT03383991
First Posted
December 14, 2017
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
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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