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Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability (TRILLARTHRO)

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ClinicalTrials.gov Identifier: NCT03200262
Recruitment Status : Unknown
Verified July 2018 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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. 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.


Condition or disease
Chronic Anterior Shoulder Instability

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic anterior shoulder instability treated with surgery using an original Trillat arthroscopic technique
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200262


Contacts
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Contact: Vincent Gremeaux +33.3.80.29.33.71 vincent.gremeaux@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Vincent GREMEAUX, MD    +33.3.80.29.33.71    vincent.gremeaux@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03200262    
Other Study ID Numbers: ORTA 2016 bis
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases