Objective Evaluation of Shoulder Pathology and Surgery

University of Lausanne Hospitals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Conditions

Glenohumeral Osteoarthritis Rotator Cuff Disease

Interventions

Body fixed 3D sensorsDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Orthopédique de la Suiss Romande

Lausanne, CH, Switzerland

Data from ClinicalTrials.gov

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