Hill-Sachs Lesion, Other Instability, Shoulder
Conditions
Keywords
Bankart repair, remplissage, Hill-Sachs defect, shoulder instability, anterior shoulder instability
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.
Interventions
PROCEDUREBankart 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.
PROCEDUREBankart repair
Bankart repair based on surgeon's preference
Sponsors
University of Ottawa
Western University, Canada
University of British Columbia
Panam Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Canada
Outcome results
None listed