Completed

NCT Number: NCT03654118

Long-term Review of a Cohort of Arthroscopic Bankart Interventions

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

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Key information

Conditions

Recurrent Anterior Shoulder Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique parc Rambot Provençale, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

Number of instability recurrence after arthroscopic Bankart intervention

Time frame: 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 outcomes

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

Time frame: Through study completion, 2 months on average

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ISIS-2017

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 31, 2018
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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