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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03383991

Enrollment

Unknown

Registered

2017-12-27

Start date

2013-09-10

Completion date

2020-09-02

Last updated

2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humeral Fracture, Proximal

Keywords

Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty

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.

Interventions

PROCEDUREReverse Total Shoulder Arthroplasty

PROCEDUREHemiarthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Constant-Murley Score	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	24 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026