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Clinical Trials/NCT00500630
NCT00500630
Completed
Not Applicable

Objective Evaluation of Shoulder Pathology and Surgery

University of Lausanne Hospitals1 site in 1 countryJuly 13, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glenohumeral Osteoarthritis
Sponsor
University of Lausanne Hospitals
Locations
1
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 13, 2007
End Date
TBD
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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