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

NCT03383991 | Completed

• 1 other identifier: 2013/1053-31/3
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Humeral Fracture, Proximal

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• WOOS (Western Ontario Osteoarthritis of the Shoulder) Index

  24 months

Study Arms (2)

Reverse Total Shoulder Arthroplasty

EXPERIMENTAL

Procedure: Reverse Total Shoulder Arthroplasty

Hemiarthroplasty

ACTIVE COMPARATOR

Procedure: Hemiarthroplasty

Interventions

Reverse Total Shoulder Arthroplasty PROCEDURE

Reverse Total Shoulder Arthroplasty

Hemiarthroplasty PROCEDURE

Hemiarthroplasty

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (1)

• 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.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Per Olerud, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Carl Ekholm, MD

  Sahlgrenska Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Consulting Orthopedic Surgeon

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 27, 2017
• Study Start: September 10, 2013
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09