- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200262
Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability (TRILLARTHRO)
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Dijon, France, 21000
- Recruiting
- Chu Dijon Bourgogne
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Contact:
- Vincent GREMEAUX, MD
- Phone Number: +33.3.80.29.33.71
- Email: vincent.gremeaux@chu-dijon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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Baseline, 3 and 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTA 2016 bis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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