A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations

Summary

Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to further improve the treatment of proximal humerus fractures and decrease the rate of fixation failures, further research is necessary. As a first step, the reasons for potential implant failures need to be understood.

This study has been initiated by scientists at the AO Research Institute Davos (ARI), Switzerland, which is the research center of the AO Foundation (www.aofoundation.org), an international non-profit organization led by surgeons specialized in fractures such as these. Researchers at the ARI have been developing a computational simulation tool to predict fixation failure and demonstrated its efficiency in laboratory conditions. This clinical study has been organised to validate this tool using patient data, by comparing the risk of mechanical failure predicted by the computer simulated model with the clinically observed fixation failure. In future, this computer simulation tool is expected to help surgeons to select the best fixation for a given patient and to develop improved implants.

Conditions

• Proximal Humeral Fracture

Interventions

DIAGNOSTIC_TEST

Post-Operative (OP) Computer Tomography (CT)

Post-OP CT of the treated shoulder

OTHER

Questionnaires on patient activity and comorbidities

* Shoulder activity scale (Marx) * Parker Mobility Scale * Barthel index * Charlson Comorbidity Score

OTHER

Grip strength measurement

Grip strength will be measured using a CE marked hydraulic hand dynamometer device.

OTHER

Non-invasive shoulder activity tracking usinig wearable sensors

Post-OP activity will be assessed via wearable CE-marked accelerometer sensors.

Sponsors & Collaborators

• AO Research Institute Davos

  lead OTHER

Principal Investigators

• Peter Varga, PhD · AO Research Institute Davos

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-02

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Austria
• Belgium

Study Locations