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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT03383991
• Collaborator: (none)
• Arms: 2
• Actual Duration (Months): 83.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Humeral Fracture, Proximal	Procedure: Reverse Total Shoulder Arthroplasty; Procedure: Hemiarthroplasty	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 10, 2013
• Actual Primary Completion Date: Sep 2, 2020
• Actual Study Completion Date: Sep 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reverse Total Shoulder Arthroplasty	Procedure: Reverse Total Shoulder Arthroplasty
Active Comparator: Hemiarthroplasty	Procedure: Hemiarthroplasty

Outcome Measures

Primary Outcome Measures

1. 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.

2. WOOS (Western Ontario Osteoarthritis of the Shoulder) Index [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Per Olerud, MD, Karolinska Institutet
• Study Director: Carl Ekholm, MD, Sahlgrenska Academy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Olerud, MD, PhD, Senior Consulting Orthopedic Surgeon, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03383991
• Other Study ID Numbers: 2013/1053-31/3
• First Posted: Dec 27, 2017
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Per Olerud, MD, PhD, Senior Consulting Orthopedic Surgeon, Karolinska Institutet: Humeral Fracture, Proximal; Arthroplasty, Replacement, Shoulder; Reverse Total Shoulder Arthroplasty; Shoulder Hemiarthroplasty
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures

Study Results

No Results Posted as of Sep 2, 2020