Glenohumeral OsteoarthritisNCT00500630
Objective Evaluation of Shoulder Pathology and Surgery
A study testing Body fixed 3D sensors in people with Glenohumeral Osteoarthritis and Rotator Cuff Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glenohumeral Osteoarthritis, Rotator Cuff Disease
- What is being tested?
- Body fixed 3D sensors
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who had a previous shoulder surgery (open or arthroscopic)
- Patients who had a contralateral shoulder pathology
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hopital Orthopédique de la Suiss Romande
Lausanne, CH, 1005
About this study
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.
- Conditions
- Glenohumeral Osteoarthritis, Rotator Cuff Disease
- Being tested
- Body fixed 3D sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body fixed 3D sensorsDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Brigitte M Jolles, MD, MSc, Study director, Centre Hospitalier Universitaire Vaudois - University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500630
- Sponsor's protocol ID
- HO 22/04
- Status last verified
- Jul 2007
- First submitted
- 12 Jul 2007
- Last updated
- 13 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Shoulder Pathology and Surgery
- ClinicalTrials.gov ID
- NCT00500630
- Acronym / sponsor ID
- HO 22/04
- Conditions
- Glenohumeral Osteoarthritis, Rotator Cuff Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who had a previous shoulder surgery (open or arthroscopic)
- Patients who had a contralateral shoulder pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body fixed 3D sensors | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte M Jolles, MD, MSc study director
Centre Hospitalier Universitaire Vaudois - University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body fixed 3D sensors in people with Glenohumeral Osteoarthritis and Rotator Cuff Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2007.