GLENOID CAVITYNCT04089293
The Postero-superior Contact and Rotator Cuff Lesion
An observational study of GLENOID CAVITY, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GLENOID CAVITY
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to Dec 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated at the Hopitaux Universitaires de Strasbourg between 01/01/2012 and 31/12/2013 under arthroscopy of anterior instability, uninjured tendinopathy of the rotator cuff, or extra-articular pathology.
Who may be able to join
- Major subject ((≥18 years old)
- Operated subject (at the HUS between 01/01/2012 and 31/12/2013) under arthroscopy of anterior instability, of an unruptured tendinopathy of the rotator cuff, or of an extra-articular pathology.
- Subject not expressing opposition to the use of his data for research purposes
Who cannot join
- Subject having expressed his opposition to participating in the study
- Patient under safeguard of justice
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie du membre supérieur Hautepierre 2
Strasbourg, 67091
Philippe CLAVERT, MD, PhD, 03 68 76 51 78, philippe.clavert@chru-strasbourg.fr
Philippe CLAVERT, MD, PhD
About this study
Official title: Does the Contact Between the Deep Surface of the Supraspinatus Muscle Tendon and the Posterior Superior Labrum Physiological ?
The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.
- Conditions
- GLENOID CAVITY
- Keywords
- GLENOID CAVITY, HUMERAL HEAD, SHOULDER JOINT, SUPRASPINATUS MUSCLE, LABRUM, ABER POSITION, SCAPULOHUMERAL, INTERNAL IMPINGEMENT, ABDUCTED POSITION, SCAPULOHUMERAL JOINT
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of posterior-superior contact in a patient with no rotator cuff lesion.
Measured: The period from January 1st, 2012 to December 31st, 2013 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Sep 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLENOID CAVITYStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CLAVERT, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089293
- Sponsor's protocol ID
- 7461
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Contact Between the Deep Surface of the Supraspinatus Muscle Tendon and the Posterior Superior Labrum Physiological ?
- ClinicalTrials.gov ID
- NCT04089293
- Acronym / sponsor ID
- 7461
- Conditions
- GLENOID CAVITY
- Keywords
- GLENOID CAVITY, HUMERAL HEAD, SHOULDER JOINT, SUPRASPINATUS MUSCLE, LABRUM, ABER POSITION, SCAPULOHUMERAL, INTERNAL IMPINGEMENT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Sep 2019 (actual)
- 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 possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated at the Hopitaux Universitaires de Strasbourg between 01/01/2012 and 31/12/2013 under arthroscopy of anterior instability, uninjured tendinopathy of the rotator cuff, or extra-articular pathology.
Key inclusion criteria (3 listed)
- Major subject ((≥18 years old)
- Operated subject (at the HUS between 01/01/2012 and 31/12/2013) under arthroscopy of anterior instability, of an unruptured tendinopathy of the rotator cuff, or of an extra-articular pathology.
- Subject not expressing opposition to the use of his data for research purposes
Key exclusion criteria (3 listed)
- Subject having expressed his opposition to participating in the study
- Patient under safeguard of justice
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of posterior-superior contact in a patient with no rotator cuff lesion.
Time frame: The period from January 1st, 2012 to December 31st, 2013 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
Related trials for GLENOID CAVITY
Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
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.
Philippe CLAVERT, MD, PhD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GLENOID CAVITY, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe CLAVERT, MD, PhD (03 68 76 51 78, philippe.clavert@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of posterior-superior contact in a patient with no rotator cuff lesion. (time frame: The period from January 1st, 2012 to December 31st, 2013 will be examined). It is what the study was designed to measure, not a finding.
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 20 Sep 2019.