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
Verified date | April 2024 |
Source | Panam Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa/Ottawa Hospital | Ottawa | Ontario |
Canada | Pan Am Clinic | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Panam Clinic | University of British Columbia, University of Ottawa, Western University, Canada |
Canada,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01532492 -
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
|
N/A | |
Recruiting |
NCT02075775 -
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
|