Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

This study is ongoing, but not recruiting participants.
University of Ottawa
University of Western Ontario, Canada
University of British Columbia
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic Identifier:
First received: March 23, 2011
Last updated: September 26, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Other Instability, Shoulder
Hill-Sachs Lesion
Procedure: Bankart repair and remplissage
Procedure: Bankart repair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial

Further study details as provided by Peter MacDonald, Panam Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Simple Shoulder Test [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.

Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bankart repair Procedure: Bankart repair
Bankart repair based on surgeon's preference
Active Comparator: Bankart repair and remplissage Procedure: 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.

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.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01324531

Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Canada, Ontario
University of Ottawa/Ottawa Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Panam Clinic
University of Ottawa
University of Western Ontario, Canada
University of British Columbia
  More Information

Responsible Party: Peter MacDonald, Department Head, Orthopaedic Surgery, Panam Clinic Identifier: NCT01324531     History of Changes
Other Study ID Numbers: REMP 01
Study First Received: March 23, 2011
Last Updated: September 26, 2016

Keywords provided by Peter MacDonald, Panam Clinic:
Bankart repair
Hill-Sachs defect
shoulder instability
anterior shoulder instability processed this record on May 25, 2017