Long-term Review of a Cohort of Arthroscopic Bankart Interventions

NCT03654118 | Completed

• 2 other identifiers: 35RC17_30252017-A01665-48
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictive value of the ISIS score in the occurrence of recurrence of instability

  Through study completion, 2 months on average

Study Arms (1)

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

Interventions

Phone follow-up OTHER

Through a short phone interview : * Determination of a complication (Infection, capsulitis, recurrence) * Determination of the Rowe score * Determination of the Walch-Duplay score

ISIS cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (11)

Clinique parc Rambot Provençale

Aix-en-Provence, 13100, France

Location

Clinique Générale d'Annecy

Annecy, 74000, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Clinique du Cambresis

Cambrai, 59400, France

Location

Clinique des Cèdres

Échirolles, 38432, France

Location

Clinique François 1er

Le Havre, 76600, France

Location

Clinique du Sport de Bordeaux-Mérignac

Mérignac, 33700, France

Location

Hôpital Archet II

Nice, 06202, France

Location

Hôpital Saint-Antoine / APHP

Paris, 75000, France

Location

Clinique Turin

Paris, 75008, France

Location

Centre Hospitalier Universitaire de RENNES

Rennes, France

Location

Study Officials

• Hervé THOMAZEAU, MD, PhD

  Rennes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: August 7, 2017
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

FR (11)