NCT Number: NCT03383991
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
70 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hemiarthroplasty
ProcedurePrimary outcomes
-
Constant-Murley Score
Time frame: 24 months
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
Time frame: 24 months
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Dec 27, 2017
- Registry last updated
- Sep 2, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Psychological Health Influences the Choice of Device in Proximal Humeral Fractures
NCT04821180
Fractures, Bone, Humeral Fracture, Proximal
View Trial DetailsOutcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
NCT03023956
Fractures, Bone, Humeral Fracture, Proximal
View Trial DetailsRetro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
NCT07663552
Fractures, Bone, Humeral Fracture, Proximal
Angers, France
View Trial DetailsRETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
NCT07558590
Arthritis, Avascular Necrosis of the Head of Humerus
Amiens, France
View Trial Details