Long-term Review of a Cohort of Arthroscopic Bankart Interventions (ISIS-2017)

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

Study Overview

• Status: Completed
• Conditions: Recurrent Anterior Shoulder Instability
• Intervention / Treatment: Other: Phone follow-up

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13100
    • Clinique parc Rambot Provençale
  • Annecy, France, 74000
    • Clinique Générale d'Annecy
  • Boulogne-Billancourt, France, 92100
    • Hopital Ambroise Pare
  • Cambrai, France, 59400
    • Clinique du Cambresis
  • Echirolles, France, 38432
    • Clinique des Cèdres
  • Le Havre, France, 76600
    • Clinique François 1er
  • Mérignac, France, 33700
    • Clinique du Sport de Bordeaux-Mérignac
  • Nice, France, 06202
    • Hôpital ARCHET II
  • Paris, France, 75008
    • Clinique Turin
  • Paris, France, 75000
    • Hôpital Saint-Antoine / APHP
  • Rennes, France
    • Centre hospitalier universitaire de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ISIS cohort; 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	Other: Phone follow-up; Through a short phone interview : Determination of a complication (Infection, capsulitis, recurrence); Determination of the Rowe score; Determination of the Walch-Duplay score

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Predictive value of the ISIS score in the occurrence of recurrence of instability	Through study completion, 2 months on average

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Hervé THOMAZEAU, MD, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): November 9, 2017
• Study Completion (Actual): November 9, 2017

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Shoulder; Arthroscopy; Bankart; ISIS
• Other Study ID Numbers: 35RC17_3025; 2017-A01665-48 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No