- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324531
Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3M 3E4
- Pan Am Clinic
-
-
Ontario
-
Ottawa, Ontario, Canada
- University of Ottawa/Ottawa Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bankart repair
|
Bankart repair based on surgeon's preference
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months post-surgery
|
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
|
24 months post-surgery
|
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.
|
24 months post-surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REMP 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Other Instability, Shoulder
-
St. Antonius HospitalCompletedDisorder of Rotator Cuff | Other Instability, Shoulder | Rotator Cuff LesionNetherlands
-
Haute Ecole de Santé VaudSwiss National Science FoundationCompletedFrozen Shoulder | Rotator Cuff, Syndrome | Humerus, Fracture | Other Instability of Joint, Shoulder RegionSwitzerland
-
Hvidovre University HospitalRecruitingShoulder Instability Subluxation BilateralDenmark
-
Ottawa Hospital Research InstituteActive, not recruiting
-
Royal National Orthopaedic Hospital NHS TrustUniversity of SydneyCompletedAtraumatic Shoulder InstabilityUnited Kingdom
-
Tzu Chi UniversityUnknownThe Effects of Muscle Characteristics on the Control of Shoulder Complex During Functional MovementsMovement Disorders | Other Instability of Joint, Shoulder Region | Strain of Shoulder Muscle (Disorder)Taiwan
-
Centre Hospitalier Universitaire DijonUnknownChronic Anterior Shoulder InstabilityFrance
-
Carolyn M HettrichUniversity of Colorado, Denver; Washington University School of Medicine; University... and other collaboratorsRecruitingOther Instability, Shoulder | Dislocations | Subluxations | Recurrent Dislocation of Shoulder RegionUnited States
-
Izmir Democracy UniversityNot yet recruitingSurgery | Anterior Shoulder Instability
-
Duke UniversityRecruitingShoulder Injuries | Anterior Shoulder Instability | Shoulder Dislocation | Instability, Joint | Shoulder Subluxation | Glenoid; DislocationUnited States
Clinical Trials on Bankart repair
-
Nova Scotia Health AuthorityCanadian Institutes of Health Research (CIHR)Recruiting
-
University of PittsburghWalter Reed National Military Medical CenterRecruitingShoulder Dislocation | Anterior Shoulder Dislocation | Glenohumeral DislocationUnited States
-
Catarina MalmbergKøge Hospital; Herlev og Gentofte Hospital; Adeas Hospitaler; Gildhøj PrivathospitalRecruiting
-
Tel-Aviv Sourasky Medical CenterUnknownRecurrent Shoulder DislocationsIsrael
-
Ottawa Hospital Research InstituteActive, not recruiting
-
Columbia UniversityNot yet recruiting
-
University Hospital, LilleCompleted
-
Western University, CanadaPanam ClinicRecruitingShoulder DislocationCanada
-
University of Western Ontario, CanadaUnknownBankart Lesions | Anterior Shoulder InstabilityCanada
-
Nova Scotia Health AuthorityRecruiting