Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Phase 2

Active, not recruiting

• Conditions: Other Instability, Shoulder; Hill-Sachs Lesion
• Interventions: Procedure: Bankart repair; Procedure: Bankart repair and remplissage

• Registration Number: NCT01324531
• Lead Sponsor: Panam Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2019-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bankart repair	Bankart repair	-
Bankart repair and remplissage	Bankart repair and remplissage	-

Primary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability (WOSI) score	24 months post-surgery	WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate

Secondary Outcome Measures

Name	Time	Method
Ultrasound imaging	24 months post-surgery	Ultrasound imaging will be conducted 24 months post-surgery and compared to pre-operative findings on CT-Scan, ultrasound and intraoperatively to establish extent of healing.
Simple Shoulder Test	24 months post-surgery	Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate
American Shoulder and Elbow Society assessment (ASES)	24 months post-surgery	The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate

Trial Locations

Locations (2)

Pan Am Clinic; 🇨🇦 Winnipeg, Manitoba, Canada

University of Ottawa/Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada