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

Humeral Fracture, Proximal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383991
• Other study ID #: 2013/1053-31/3
• Status: Completed
• Phase: N/A
• Start date: September 10, 2013
• Est. completion date: September 2, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture, Proximal
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Reverse Total Shoulder Arthroplasty

• Hemiarthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	WOOS (Western Ontario Osteoarthritis of the Shoulder) Index		24 months