Objective Evaluation of Shoulder Pathology and Surgery

The goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotator cuff disease, using the activities of daily living described in the Simple Shoulder Test (SST) as a reference.

The study was set up as a clinical trial including patients over an observation period of one year and a control group of subjects. Clinical evaluations will be made at baseline, 3 months, 6 months and 1 year after surgery by two independent observers. Miniature sensors each containing three 3D gyroscopes and three 3D accelerometers will allow computing new kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.

Completed

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Key information

Conditions

Glenohumeral Osteoarthritis Rotator Cuff Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Orthopédique de la Suiss Romande

Lausanne, CH, 1005, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

at least 18 years old
patients with a unilateral rotator cuff disease implying a transfixiant supraspinatus rupture of at least 1 cm2, as determined by Magnetic Resonance Imaging (MRI), or a unilateral glenohumeral osteoarthritis stage II or III according the radiologic criteria published by Koss
informed and signed consent

Exclusion criteria

Patients who had a previous shoulder surgery (open or arthroscopic)
Patients who had a contralateral shoulder pathology

Treatment and study plan

Body fixed 3D sensors

Device

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

First posted: Jul 13, 2007
Registry last updated: Jul 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed