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Objective Evaluation of Shoulder Pathology and Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00500630
First received: July 12, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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: Open Label

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00500630     History of Changes
Other Study ID Numbers: HO 22/04
Study First Received: July 12, 2007
Last Updated: July 12, 2007
Health Authority: Switzerland: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014