Objective Evaluation of Shoulder Pathology and Surgery

Not Applicable

Completed

• Conditions: Rotator Cuff Disease; Glenohumeral Osteoarthritis

• Registration Number: NCT00500630
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2007-07
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Last Update Submitted: 2007-07-12
• Study First Posted: 2007-07-13
• Last Update Posted: 2007-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Hopital Orthopédique de la Suiss Romande; 🇨🇭 Lausanne, CH, Switzerland