Clinical trial NCT01324531: Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
Official title: Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Other Instability, Shoulder
Hill-Sachs Lesion
Keywords: Bankart repair
remplissage
Hill-Sachs defect
shoulder instability
anterior shoulder instability
Lead sponsor: Panam Clinic
Sponsor class: OTHER
Collaborators: name: University of Ottawa
name: Western University, Canada
name: University of British Columbia
First posted: 2011-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Ontario Shoulder Instability (WOSI) score
timeFrame: 24 months post-surgery
Secondary outcomes:
measure: Simple Shoulder Test
timeFrame: 24 months post-surgery
measure: American Shoulder and Elbow Society assessment (ASES)
timeFrame: 24 months post-surgery
measure: Ultrasound imaging
timeFrame: 24 months post-surgery
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
city: Ottawa
country: Canada
facility: University of Ottawa/Ottawa Hospital
state: Ontario
Study officials:
References:
citation: Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.
citation: Burkhart SS, Danaceau SM. Articular arc length mismatch as a cause of failed bankart repair. Arthroscopy. 2000 Oct;16(7):740-4. doi: 10.1053/jars.2000.7794.
citation: Kropf EJ, Tjoumakaris FP, Sekiya JK. Arthroscopic shoulder stabilization: is there ever a need to open? Arthroscopy. 2007 Jul;23(7):779-84. doi: 10.1016/j.arthro.2007.03.004.