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

2019-08-19 19:46:42 | BioPortfolio


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 (, 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.


Older adult patients with complex, displaced and/or unstable proximal humerus fractures treated with the PHILOS plate (DePuy Synthes Inc.) will be recruited. Detailed patient background information will be assessed. Surgical details will be acquired. Pre-, intra- and post-OP imaging data will be collected in frame of the standard treatment protocol. A post-OP CT scan, which is performed only occasionally as standard of care, will be acquired for all patients participating in this study. The de-identified medical images will be transferred via secure file transfer protocol (FTP) to the sponsor. Patient activity will be recorded in the first 6 post-OP weeks by means of two wearable activity trackers attached on the skin of the treated upper arm and the chest. The tracker containing the encoded data will be shipped back to the sponsor.

According to the standard post-OP protocols, follow-up (FU) examinations will be performed at 6 weeks, 3 months and 6 months after treatment. Additionally, another FU visit will be required at 3 weeks after surgery, where the activity trackers will be exchanged. FU radiographs during the standard of care visits will be compared with post-OP radiographs to determine if any mechanical failure has occurred.

Mechanical failure or no failure status of the fixation will be determined at 6 months following fracture treatment.

The patient-specific fixation failure risk will be prospectively predicted by means of computer simulations created from the pre-OP and post-OP CT images and surgical details. The prediction accuracy of the simulations will be evaluated by comparing the predicted failure risk with the clinically observed failure / no failure outcome. As a second approach, patient-specific shoulder activity (estimated based on patient pre-injury activity or measured directly post-operatively) will be incorporated into the simulations sequentially and its effect on the prediction accuracy will be evaluated.

The interventions in this study, i.e. the examinations that are beyond the current standard of care, will be i) the extra acquisition of the post-OP CT image in the cases that the treating surgeon is not requesting them, ii) the questionnaires on comorbidities and pre-injury activity, and grip strength measurements to estimate activity of the patient and iii) the post-OP activity measurement by means of wearable sensors.

Study Design


Proximal Humeral Fracture


Post-Operative (OP) Computer Tomography (CT), Questionnaires on patient activity and comorbidities, Grip strength measurement, Non-invasive shoulder activity tracking usinig wearable sensors


Medical University of Innsbruck




AO Research Institute Davos

Results (where available)

View Results


Published on BioPortfolio: 2019-08-19T19:46:42-0400

Clinical Trials [3845 Associated Clinical Trials listed on BioPortfolio]

Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients

Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve...

THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

The objective of this study is to analyze subjects having a normal hip and compare the in vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased hip ...

Multi-Slice CT of the Chest( MSCT Findings After Lung Transplantation)

The purpose of the study is to compare Multi-Slice Computer Tomography findings with histological and physiological changes observed in transplanted lungs with Progressive Graft Disfunctio...

The Role Of Noninvasive 320-Row Multidetector Computer Tomography

Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection ...

Prospective Quality of Life Study in Pituitary Surgery

Post-operative assessment and debridement are key components in patient care for surgery patients. However, a standardized protocol for management after endoscopic skull base surgery is un...

PubMed Articles [25728 Associated PubMed Articles listed on BioPortfolio]

Predicting Post-Fontan Length of Stay: The Limits of Measured Variables.

Post-operative length of stay (LOS) is an important metric for both healthcare providers and patients and their families. Predicting LOS is a challenge as it is sensitive to multitudinous patient and ...

Do patients consider computer-adaptive measures more appropriate than static questionnaires?

Computer-adaptive tests (CAT) use individualised sets of questions to assess patient-reported health states, whereas static (conventional) questionnaires present the same questions to all patients. CA...

Added value of 18Ffluorodeoxyglucose positron emission tomography/computed tomography for the diagnosis of post-operative instrumented spine infection.

Post-operative instrumented spine infection (PISI) is an infrequent complication. Diagnosis of spinal implant infection can be difficult, especially in case of chronic infection.

A 4 year quality improvement initiative reducing post-operative nausea and vomiting in children undergoing strabismus surgery at a quaternary paediatric hospital.

Post-operative Nausea and Vomiting is a significant cause of morbidity in pediatric anesthesia. As well as patient discomfort, post-operative nausea and vomiting can also result in dehydration, delaye...

Clinical- and surgery-specific risk factors for post-operative sepsis: a systematic review and meta-analysis of over 30 million patients.

Post-operative sepsis is a severe complication of surgery, which often worsens the clinical outcomes. While several risk factors have been identified, the importance of others remains uncertain. This ...

Medical and Biotech [MESH] Definitions

Tomography using single-photon emitting RADIONUCLIDES to create images that are captured in times corresponding to various points in the cardiac cycle.

Computed tomography where there is continuous X-ray exposure to the patient while being transported in a spiral or helical pattern through the beam of irradiation. This provides improved three-dimensional contrast and spatial resolution compared to conventional computed tomography, where data is obtained and computed from individual sequential exposures.

Intraoperative computer-assisted 3D navigation and guidance system generally used in neurosurgery for tracking surgical tools and localize them with respect to the patient's 3D anatomy. The pre-operative diagnostic scan is used as a reference and is transferred onto the operative field during surgery.

Modality of computed tomography in which the patient is irradiated in a spiral path around the body with a cone or pyramid-shaped beam.

Computer-assisted processing of electric, ultrasonic, or electronic signals to interpret function and activity.

More From BioPortfolio on "A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations"

Quick Search

Relevant Topics

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Searches Linking to this Trial