Chronic Anterior Shoulder InstabilityTRILLARTHRONCT03200262
Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability
An observational study of Chronic Anterior Shoulder Instability, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Chronic Anterior Shoulder Instability
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Dec 2018
- 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 16 to 45 years
- All sexes
- Child, Adult
Study population: Patients with chronic anterior shoulder instability treated with surgery using an original Trillat arthroscopic technique
Who may be able to join
- Persons informed about the research
- Male or female
- Age between 16 and 45 years
- Regular sport activity (leisure or competition)
- First surgical indication for stabilisation using the Trillat arthroscopic technique
- Patient operated on using the Trillat arthroscopic technique for chronic anterior shoulder instability in the orthopaedic and trauma unit of Dijon CHU
Who cannot join
- Persons without health insurance cover
- Concomitant, disabling shoulder joint disease inflammatory rheumatism, which could be exacerbated by the tests
- Associated lesions in the shoulder: rupture of rotator cuff tendons, neurological lesions, bone lesions: fracture of the neck of humerus, of the greater tubercle or the coracoid process
- Paraplegia and peripheral neurological disease
- Surgery other than the Trillat arthroscopic technique alone
- Treatment with the Trillat arthroscopic technique as second line, after failure of the first strategy
Show all 14Show fewer
- Contralateral history of dislocation with surgical repair
- History of disease with excess laxity (collagen disease, Marfan, Elhers-Danlos)
- History of debilitating pain in the back, elbows or wrists
- Contra-indication for isokinetic tests
- Cognitive disorders
- Major post-operative complications delaying the rehabilitation
- Early recurrence of dislocation after surgery
- Post-operative immobilisation protocol not respected
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Vincent GREMEAUX, MD, +33.3.80.29.33.71, vincent.gremeaux@chu-dijon.fr
About this study
The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.
Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.
Read more
Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.
The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.
- Conditions
- Chronic Anterior Shoulder Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from maximum muscle torque in patients who have undergone surgical treatment for chronic anterior shoulder instability before and after surgery using the Trillat arthroscopic technique
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startJan 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anterior Shoulder InstabilityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200262
- Sponsor's protocol ID
- ORTA 2016 bis
- Acronym
- TRILLARTHRO
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability
- ClinicalTrials.gov ID
- NCT03200262
- Acronym / sponsor ID
- TRILLARTHRO / ORTA 2016 bis
- Conditions
- Chronic Anterior Shoulder Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Jun 2017 (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 shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.
Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.
Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.
The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with chronic anterior shoulder instability treated with surgery using an original Trillat arthroscopic technique
Key inclusion criteria (6 listed)
- Persons informed about the research
- Male or female
- Age between 16 and 45 years
- Regular sport activity (leisure or competition)
- First surgical indication for stabilisation using the Trillat arthroscopic technique
Key exclusion criteria (14 listed)
- Persons without health insurance cover
- Concomitant, disabling shoulder joint disease inflammatory rheumatism, which could be exacerbated by the tests
- Associated lesions in the shoulder: rupture of rotator cuff tendons, neurological lesions, bone lesions: fracture of the neck of humerus, of the greater tubercle or the coracoid process
- Paraplegia and peripheral neurological disease
- Surgery other than the Trillat arthroscopic technique alone
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
Change from maximum muscle torque in patients who have undergone surgical treatment for chronic anterior shoulder instability before and after surgery using the Trillat arthroscopic technique
Time frame: Baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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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.
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 Chronic Anterior Shoulder Instability, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 14 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 31 Jul 2018. 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 Vincent Gremeaux (+33.3.80.29.33.71, vincent.gremeaux@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from maximum muscle torque in patients who have undergone surgical treatment for chronic anterior shoulder instability before and after surgery using the Trillat arthroscopic technique (time frame: Baseline, 3 and 6 months). 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 31 Jul 2018.