Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Other Instability, Shoulder Hill-Sachs Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bankart repair

Group Type ACTIVE_COMPARATOR

Bankart repair

Intervention Type PROCEDURE

Bankart repair based on surgeon's preference

Bankart repair and remplissage

Group Type ACTIVE_COMPARATOR

Bankart repair and remplissage

Intervention Type PROCEDURE

Bankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage.

Interventions

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Bankart repair and remplissage

Bankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage.

Intervention Type PROCEDURE

Bankart repair

Bankart repair based on surgeon's preference

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No