Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Panam Clinic
Sponsor:
Collaborators:
University of Ottawa
University of Western Ontario, Canada
University of British Columbia
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
ClinicalTrials.gov Identifier:
NCT01324531
First received: March 23, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Panam Clinic:

Primary Outcome Measures:
  • Western Ontario Shoulder Instability (WOSI) score [ Time Frame: 24 months post-surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • must have anterior shoulder instability and Hill-Sachs defect
  • must have anterior instability with at least a 15% 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 worker's compensation claim
  • 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 ClinicalTrials.gov identifier: NCT01324531

Locations
Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Sheila McRae, MSc, PhD (C)    204-925-7469    smcrae@panamclinic.com   
Contact: Jeff Leiter, PhD    204-925-2775    jleiter@panamclinic.com   
Principal Investigator: Peter B MacDonald, MD FRCSC         
Canada, Ontario
University of Ottawa/Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Kimberly Bell, BA    613-737-8920    kibell@ottawahospital.on.ca   
Principal Investigator: Peter Lapner, MD FRCSC         
Sponsors and Collaborators
Panam Clinic
University of Ottawa
University of Western Ontario, Canada
University of British Columbia
  More Information

Publications:
Responsible Party: Peter MacDonald, Department Head, Orthopaedic Surgery, Panam Clinic
ClinicalTrials.gov Identifier: NCT01324531     History of Changes
Other Study ID Numbers: REMP 01
Study First Received: March 23, 2011
Last Updated: March 5, 2014
Health Authority: Canada: Health Protection Branch

Keywords provided by Panam Clinic:
Bankart repair
remplissage
Hill-Sachs defect
shoulder instability
anterior shoulder instability

Additional relevant MeSH terms:
Humeral Fractures
Arm Injuries
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on July 23, 2014