Anxiety Depression DisorderRepriseNCT05531929
Role of Anxio-depressive History on Return to Work and Sport After Rotator Cuff Surgery
An observational study of Anxiety Depression Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Depression Disorder
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2022to 22 Dec 2022
- 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: Major subject (≥ 18 years) operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture
Who may be able to join
- Major subject (≥ 18 years)
- Operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture, retracted in zone 1, resistant to medical treatment with a mobile shoulder, fatty degeneration of stage 2 or less with also a preserved subacromial space
- Subject not objecting to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie orthopédique de l'épaule et du coude - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Study of the Role of Anxiety-related Antecedents on the Resumption of Work and Sport in a Series of Patients Operated on for Rotator Cuff Repair
Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.).
And it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). These 2 pathologies are therefore responsible for significant economic expenses.
It is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.
- Conditions
- Anxiety Depression Disorder
- Keywords
- Anxiety Depression Disorder, Rotator cuff repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the duration of complete sports cessation after rotator cuff repair surgery
Measured: 6 months after rotator cuff repair surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start22 May 2022
- Primary completion22 Oct 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Depression DisorderStudies 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531929
- Sponsor's protocol ID
- 8614
- Acronym
- Reprise
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2022
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Anxiety-related Antecedents on the Resumption of Work and Sport in a Series of Patients Operated on for Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05531929
- Acronym / sponsor ID
- Reprise / 8614
- Conditions
- Anxiety Depression Disorder
- Keywords
- Anxiety Depression Disorder, Rotator cuff repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 8 Sep 2022 (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.
Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.).
And it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). These 2 pathologies are therefore responsible for significant economic expenses.
It is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.
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
- Major subject (≥ 18 years) operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture
Key inclusion criteria (3 listed)
- Major subject (≥ 18 years)
- Operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture, retracted in zone 1, resistant to medical treatment with a mobile shoulder, fatty degeneration of stage 2 or less with also a preserved subacromial space
- Subject not objecting to the reuse of their data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
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
Measurement of the duration of complete sports cessation after rotator cuff repair surgery
Time frame: 6 months after rotator cuff repair surgery
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 19 Dec 2023.
Related trials for Anxiety Depression Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anxiety Depression Disorder, 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 1 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 19 Dec 2023. 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?
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.
What does the primary outcome measure?
Measurement of the duration of complete sports cessation after rotator cuff repair surgery (time frame: 6 months after rotator cuff repair surgery). 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 19 Dec 2023.