NCT00500630

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
Last Updated

July 13, 2007

Status Verified

July 1, 2007

First QC Date

July 12, 2007

Last Update Submit

July 12, 2007

Conditions

Glenohumeral OsteoarthritisRotator Cuff Disease

Interventions

Body fixed 3D sensorsDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who had a previous shoulder surgery (open or arthroscopic)
  • Patients who had a contralateral shoulder pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Orthopédique de la Suiss Romande

Lausanne, CH, 1005, Switzerland

Location

Study Officials

  • Brigitte M Jolles, MD, MSc

    Centre Hospitalier Universitaire Vaudois - University of Lausanne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Last Updated

July 13, 2007

Record last verified: 2007-07

Locations

CH(1)