Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Panam Clinic

Status and phase

Active, not recruiting

Phase 2

Conditions

Hill-Sachs Lesion

Other Instability, Shoulder

Treatments

Procedure: Bankart repair

Procedure: Bankart repair and remplissage

Study type

Interventional

Funder types

Other

Identifiers

NCT01324531

REMP 01

Details and patient eligibility

About

The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.

Full description

Significant osseous defects of the glenohumeral joint can often lead to failure of arthroscopic shoulder stabilization procedures. The best treatment in the setting of shoulder instability with significant glenoid and/or humeral defects remains controversial. Several open procedures have been suggested, but arthroscopic methods have started to garner some attention in the literature. In patients with an engaging Hill-Sachs lesion without significant glenoid bone loss, arthroscopic remplissage consisting of arthroscopic posterior capsulodesis and infraspinatus tenodesis to fill the Hill-Sachs lesion has been proposed as a novel treatment method.

The authors believe it is scientifically necessary to investigate the role of addition of arthroscopic infraspinatus remplissage to the conventional arthroscopic Bankart repair. As more surgeons are trained in the technique, it will be performed more frequently. Increased patient awareness continues to lead to increasing demand for minimally invasive approaches. Arthroscopic remplissage brings with it an increase in operative time, with a theorized risk of reduction in dislocation risk. For these reasons, the authors believe that it is scientifically and fiscally necessary to determine the difference in outcome between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage for patients with anterior shoulder instability and a Hill-Sachs defect in the framework of a prospective, randomized controlled study.

Enrollment

150 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

14 years or older
must have anterior shoulder instability and Hill-Sachs defect
must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss

Exclusion criteria

Glenoid defect >15% of AP diameter of glenoid
significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability)
active joint or systemic infection
significant muscle paralysis
rotator cuff or Charcot's arthropathy
significant medical comorbidity that may alter effectiveness of surgical intervention
major medical illness
unable to speak French or English
psychiatric illness that precludes informed consent
unwilling to be followed for 2 years