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Objective Evaluation of Shoulder Pathology and Surgery

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00500630
Collaborator
(none)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Body fixed 3D sensors
 N/A

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00500630
    Other Study ID Numbers:
    • HO 22/04
    First Posted:
    Jul 13, 2007
    Last Update Posted:
    Jul 13, 2007
    Last Verified:
    Jul 1, 2007
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Jul 13, 2007