Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
Primary Purpose
Other Instability, Shoulder, Hill-Sachs Lesion
Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bankart repair and remplissage
Bankart repair
Sponsored by
About this trial
This is an interventional treatment trial for Other Instability, Shoulder focused on measuring Bankart repair, remplissage, Hill-Sachs defect, shoulder instability, anterior shoulder instability
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
Sites / Locations
- Pan Am Clinic
- University of Ottawa/Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bankart repair
Bankart repair and remplissage
Arm Description
Outcomes
Primary Outcome Measures
Western Ontario Shoulder Instability (WOSI) score
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
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)
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
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.
Full Information
NCT ID
NCT01324531
First Posted
March 23, 2011
Last Updated
March 27, 2023
Sponsor
Panam Clinic
Collaborators
University of Ottawa, Western University, Canada, University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01324531
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panam Clinic
Collaborators
University of Ottawa, Western University, Canada, University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Instability, Shoulder, Hill-Sachs Lesion
Keywords
Bankart repair, remplissage, Hill-Sachs defect, shoulder instability, anterior shoulder instability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bankart repair
Arm Type
Active Comparator
Arm Title
Bankart repair and remplissage
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Bankart repair and remplissage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bankart repair
Intervention Description
Bankart repair based on surgeon's preference
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability (WOSI) score
Description
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
Time Frame
24 months post-surgery
Secondary Outcome Measure Information:
Title
Simple Shoulder Test
Description
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
Time Frame
24 months post-surgery
Title
American Shoulder and Elbow Society assessment (ASES)
Description
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
Time Frame
24 months post-surgery
Title
Ultrasound imaging
Description
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.
Time Frame
24 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
Facility Name
University of Ottawa/Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
11027751
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.
Results Reference
background
PubMed Identifier
11027759
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.
Results Reference
background
PubMed Identifier
17637415
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.
Results Reference
background
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Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
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