Treatment of Proximal Humerus Fractures in the Elderly (prox_hum)

University Hospital Basel

Status: Completed

Conditions: Humeral Fractures

Treatments: Procedure: treatment/medical device; Procedure: standard

Study type: Observational

Funder types: Other

Identifiers

NCT02566018

2014-310

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

experimental intervention

Description:

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.

Treatment:

Procedure: treatment/medical device

control intervention

Description:

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.

Treatment:

Procedure: standard