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OpenTrials
Completed

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.

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Key information

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

Reverse Total Shoulder Arthroplasty

Procedure

Hemiarthroplasty

Procedure

Primary outcomes

  1. 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.

  2. 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.

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