Long-term Review of a Cohort of Arthroscopic Bankart Interventions

NCT ID: NCT03654118

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-07
• Study Completion Date: 2017-11-09

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

Conditions

Recurrent Anterior Shoulder Instability

Keywords

Arthroscopy; Bankart; Shoulder; ISIS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Phone follow-up

Intervention Type: OTHER

Through a short phone interview :

• Determination of a complication (Infection, capsulitis, recurrence)
• Determination of the Rowe score
• Determination of the Walch-Duplay score

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Major patient
• Patient who already volunteered in a first 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé THOMAZEAU, MD, PhD

Role: STUDY_DIRECTOR

Rennes University Hospital

Locations

Clinique parc Rambot Provençale

Aix-en-Provence, , France

Clinique Générale d'Annecy

Annecy, , France

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Clinique du Cambresis

Cambrai, , France

Clinique des Cèdres

Échirolles, , France

Clinique François 1er

Le Havre, , France

Clinique du Sport de Bordeaux-Mérignac

Mérignac, , France

Hôpital Archet II

Nice, , France

Hôpital Saint-Antoine / APHP

Paris, , France

Clinique Turin

Paris, , France

Centre Hospitalier Universitaire de RENNES

Rennes, , France

Countries

France

Other Identifiers

2017-A01665-48

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_3025

Identifier Type: -

Identifier Source: org_study_id