Clinical trial NCT03654118: Long-term Review of a Cohort of Arthroscopic Bankart Interventions
Official title: Long-term Review of a Cohort of Arthroscopic Bankart Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Anterior Shoulder Instability
Keywords: Arthroscopy
Bankart
Shoulder
ISIS
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart)

Brief summary: Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.

Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).

Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.

Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.

The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.

The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability


Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient who already volunteered in a first ISIS study

Inclusion Criteria of the ISIS Study:

* Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of the indication of operation an ISIS score of ≤ 4 points (regardless of the positive criteria) (see Annex 2- ISIS score)
* Age\> 16 years
* Supported by a joint arthroscopic technique completed.
* Patient not objecting to his participation in the study

Exclusion Criteria (same as those of the ISIS study)

* First dislocation or resumption of another technique at the time of indication for surgery
* Voluntary or multidirectional instability at the time of the indication of operation
* Painful shoulder without instability felt at the time of the operative indication
* Lesion of the cap (perioperative report)
* Humeral lesions Avulsion Gleno-humeral Ligament (per-operative finding)
* Unsuccessful technique
* Major benefiting from a legal protection measure (safeguard of justice, trusteeship, guardianship)

Primary outcomes:
measure: Number of instability recurrence after arthroscopic Bankart intervention
timeFrame: Through study completion, 2 months on average
Secondary outcomes:
measure: Predictive value of the ISIS score in the occurrence of recurrence of instability
timeFrame: Through study completion, 2 months on average
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Clinique parc Rambot Provençale
city: Annecy
country: France
facility: Clinique Générale d'Annecy
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Cambrai
country: France
facility: Clinique du Cambresis
city: Echirolles
country: France
facility: Clinique des Cèdres
city: Le Havre
country: France
facility: Clinique François 1er
city: Mérignac
country: France
facility: Clinique du Sport de Bordeaux-Mérignac
city: Nice
country: France
facility: Hôpital Archet II
city: Paris
country: France
facility: Hôpital Saint-Antoine / APHP
city: Paris
country: France
facility: Clinique Turin
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de RENNES
Study officials:
affiliation: Rennes University Hospital
name: Hervé THOMAZEAU, MD, PhD
role: STUDY_DIRECTOR
References: