Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Other Instability, Shoulder
- Sponsor
- Panam Clinic
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Western Ontario Shoulder Instability (WOSI) score
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Peter MacDonald
Department Head, Orthopaedic Surgery
Panam Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Western Ontario Shoulder Instability (WOSI) score
Time Frame: 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 Outcomes
- Ultrasound imaging(24 months post-surgery)
- Simple Shoulder Test(24 months post-surgery)
- American Shoulder and Elbow Society assessment (ASES)(24 months post-surgery)