Long-term Review of a Cohort of Arthroscopic Bankart Interventions

Completed

• Conditions: Recurrent Anterior Shoulder Instability
• Interventions: Other: Phone follow-up

• Registration Number: NCT03654118
• Lead Sponsor: Rennes University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-07
• Primary Completion: 2017-11-09
• Study Completion: 2017-11-09
• Status Verified: 2018-08
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ISIS cohort	Phone follow-up	Patients operated between December 2007 and December 2008 for recurrent shoulder instability using the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of indication for surgery an ISIS score ≤ 4 points Phone follow-up

Primary Outcome Measures

Name	Time	Method
Number of instability recurrence after arthroscopic Bankart intervention	Through study completion, 2 months on average	The rate of instability recurrence 9 years after an arthroscopic Bankart intervention, is derived from the patient's responses to the interview

Secondary Outcome Measures

Name	Time	Method
Predictive value of the ISIS score in the occurrence of recurrence of instability	Through study completion, 2 months on average

Trial Locations

Locations (11)

Clinique des Cèdres; 🇫🇷 Echirolles, France

Clinique Générale d'Annecy; 🇫🇷 Annecy, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

Clinique François 1er; 🇫🇷 Le Havre, France

Clinique du Sport de Bordeaux-Mérignac; 🇫🇷 Mérignac, France

Centre Hospitalier Universitaire de RENNES; 🇫🇷 Rennes, France

Clinique parc Rambot Provençale; 🇫🇷 Aix En Provence, France

Clinique du Cambresis; 🇫🇷 Cambrai, France

Hôpital Archet II; 🇫🇷 Nice, France

Hôpital Saint-Antoine / APHP; 🇫🇷 Paris, France

Clinique Turin; 🇫🇷 Paris, France