Recurrent Anterior Shoulder Instability Clinical Trial
— ISIS-2017Official title:
Long-term Review of a Cohort of Arthroscopic Bankart Interventions
| Verified date | August 2018 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | November 9, 2017 |
| Est. primary completion date | November 9, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Echirolles | |
| France | Clinique François 1er | Le Havre | |
| France | Clinique du Sport de Bordeaux-Mérignac | Mérignac | |
| France | Hôpital Archet II | Nice | |
| France | Clinique Turin | Paris | |
| France | Hôpital Saint-Antoine / APHP | Paris | |
| France | Centre Hospitalier Universitaire de RENNES | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Predictive value of the ISIS score in the occurrence of recurrence of instability | Through study completion, 2 months on average |