Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Other Instability, Shoulder Clinical Trial

Official title:

Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01324531
• Other study ID #: REMP 01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Panam Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bankart Lesions
• Hill-Sachs Lesion
• Other Instability, Shoulder

Intervention

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.
• Bankart repair
Bankart repair based on surgeon's preference

Locations

Country	Name	City	State
Canada	University of Ottawa/Ottawa Hospital	Ottawa	Ontario
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
Panam Clinic	University of British Columbia, University of Ottawa, Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months post-surgery
Secondary	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	24 months post-surgery
Secondary	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	24 months post-surgery
Secondary	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.	24 months post-surgery