Glenohumeral Osteoarthritis Clinical Trial
NCT number | NCT00500630 |
Other study ID # | HO 22/04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 12, 2007 |
Last updated | July 12, 2007 |
Verified date | July 2007 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Switzerland | Hopital Orthopédique de la Suiss Romande | Lausanne | CH |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne Hospitals |
Switzerland,
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