Treatment of Proximal Humerus Fractures in the Elderly

Completed

• Conditions: Humeral Fractures
• Interventions: Procedure: standard; Procedure: treatment/medical device

• Registration Number: NCT02566018
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

Detailed Description

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age of 65 years or above
• Proximal humerus fracture
• Informed consent by the patient or legal representatives to participate in the study

Exclusion Criteria

• More than one fracture, polytrauma
• Suspicion of a pathological fracture in the context of known or unknown malignancy
• Previous surgery of the proximal humerus on the same side
• High energy trauma
• Open Fracture
• Insufficient German language skills

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control intervention	standard	Since May 2013 we have changed our treatment algorithm for the treatment of fractures of the humeral head in the elderly. Before this change in algorithm we used PHILOS plates extensively and rarely Inverse Shoulder prostheses. In general all proximal humerus fractures were operated except minimally or undisplaced.
experimental intervention	treatment/medical device	A greater degree of initial displacement is tolerated to allow for conservative, non-operative treatment in more simple fracture patterns. Two-part fractures with marked displacement including two part patterns with a non-displaced greater or minor tuberosity fracture (formally three part fractures) are treated with a proximal humerus nail; and displaced three and four part fractures are primarily managed with a reverse total shoulder arthroplasty. Proximal Humeral Internal Locking System (PHILOS)-plates are only used exceptionally in this group of patients.

Primary Outcome Measures

Name	Time	Method
personal dependency status	6 months	A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.

Secondary Outcome Measures

Name	Time	Method
General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)	6 months	The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.
Shoulder pain and disability index (SPADI)	6 months	The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available
SSV	6 months	The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.
Quality of life (utilities) derived using EQ-5D-5L	6 months	Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).
range of motion	6 months

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland