Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
|ClinicalTrials.gov Identifier: NCT01324531|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Other Instability, Shoulder Hill-Sachs Lesion||Procedure: Bankart repair and remplissage Procedure: Bankart repair||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||March 2011|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2019|
|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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324531
|Pan Am Clinic|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|University of Ottawa/Ottawa Hospital|
|Ottawa, Ontario, Canada|