Objective Evaluation of Shoulder Pathology and Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Glenohumeral Osteoarthritis Rotator Cuff Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Body fixed 3D sensors

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Brigitte M Jolles, MD, MSc

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire Vaudois - University of Lausanne

Locations

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Hopital Orthopédique de la Suiss Romande

Lausanne, CH, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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HO 22/04

Identifier Type: -

Identifier Source: org_study_id