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NCT00500630 Clinical Trial

Objective Evaluation of Shoulder Pathology and Surgery

Glenohumeral Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• Body fixed 3D sensors

Locations
Country Name City State
Switzerland Hopital Orthopédique de la Suiss Romande Lausanne CH

Sponsors (1)
Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

See also
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Recruiting NCT05847062 - Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty. N/A
Recruiting NCT04105478 - Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis N/A
Recruiting NCT03866330 - Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis Phase 1/Phase 2
Recruiting NCT04845074 - Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis N/A
Terminated NCT03586687 - Osteoarthritis Shoulder Injection Study Phase 4
Completed NCT03379545 - 3D MR Versus 3D CT for Glenohumeral Arthritis N/A
Recruiting NCT06269705 - ZILRETTA in Subjects With Glenohumeral Osteoarthritis Phase 3
Active, not recruiting NCT06171542 - Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis Phase 1
Completed NCT00436969 - ORTHOVISC Shoulder Osteoarthritis Study Phase 3
Recruiting NCT03869229 - Adipose-derived Mesenchymal Stem Cells in Osteoarthritis Phase 1/Phase 2