Objective Evaluation of Shoulder Pathology and Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00500630|
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : July 13, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Glenohumeral Osteoarthritis Rotator Cuff Disease||Device: Body fixed 3D sensors||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500630
|Hopital Orthopédique de la Suiss Romande|
|Lausanne, CH, Switzerland, 1005|
|Study Director:||Brigitte M Jolles, MD, MSc||Centre Hospitalier Universitaire Vaudois - University of Lausanne|