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Objective Evaluation of Shoulder Pathology and Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500630
First Posted: July 13, 2007
Last Update Posted: July 13, 2007
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.
Information provided by:
University of Lausanne Hospitals
  Purpose

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 Intervention
Glenohumeral Osteoarthritis Rotator Cuff Disease Device: Body fixed 3D sensors

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
Hopital Orthopédique de la Suiss Romande
Lausanne, CH, Switzerland, 1005
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Director: Brigitte M Jolles, MD, MSc Centre Hospitalier Universitaire Vaudois - University of Lausanne
  More Information

ClinicalTrials.gov Identifier: NCT00500630     History of Changes
Other Study ID Numbers: HO 22/04
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: July 13, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases