Overview

This trial is active, not recruiting.

Conditions other instability, shoulder, hill-sachs lesion
Treatments bankart repair and remplissage, bankart repair
Phase phase 2
Sponsor Panam Clinic
Collaborator University of Ottawa
Start date March 2011
End date March 2017
Trial size 150 participants
Trial identifier NCT01324531, REMP 01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
bankart repair
Bankart repair based on surgeon's preference
(Active Comparator)
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.

Primary Outcomes

Measure
Western Ontario Shoulder Instability (WOSI) score
time frame: 24 months post-surgery

Secondary Outcomes

Measure
Simple Shoulder Test
time frame: 24 months post-surgery
American Shoulder and Elbow Society assessment (ASES)
time frame: 24 months post-surgery
Ultrasound imaging
time frame: 24 months post-surgery

Eligibility Criteria

Male or female participants at least 14 years old.

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

Additional Information

Official title Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Panam Clinic.