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Approach to Shoulder Instability

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ClinicalTrials.gov Identifier: NCT02060227
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE March 5, 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02060227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
The American Shoulder and Elbow Surgeon's (ASES) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Approach to Shoulder Instability
Official Title  ICMJE Approach to Shoulder Instability: a Randomized, Controlled Trial
Brief Summary The primary research question is to determine whether patients who undergo a stabilization of the shoulder using a novel decision-making algorithm (ISIS Score) have improved disease-specific quality of life at 1 year post-operatively, as measured by the Western Ontario Instability Index (WOSI) compared with patients who undergo stabilization using a conventional decision-making algorithm. Secondary outcomes include the American Shoulder and Elbow Surgeon's (ASES) score, and difference in recurrence rates of dislocation between the two decision-making algorithms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anterior Shoulder Instability
Intervention  ICMJE
  • Procedure: Open Latarjet procedure
  • Procedure: Arthroscopic Bankart repair
Study Arms  ICMJE
  • Active Comparator: Arthroscopic Bankart repair
    After the diagnostic arthroscopy is completed, any other pathology is documented. At least 3 anchors will be used for the bankart repair for repair of the labrum with an inferior to superior capsular shift. The suture anchors used will be at the discretion of the surgeon but will be of the screw-in variety. The sutures are passed through the labrum, and the labrum is tied to the glenoid rim after the bone is prepared in the standard fashion. The surgical times will be recorded on standardized forms.
    Intervention: Procedure: Arthroscopic Bankart repair
  • Active Comparator: Open Latarjet procedure
    A deltopectoral approach is used. The coracoacromial ligament (CAL) is exposed and incised 1 cm from its coracoid attachment. Harvesting of a 2.5- to 3-cm coracoid graft allows use of 2 screws for fixation to the glenoid neck through a subscapularis-splitting approach. The stump of the CAL is repaired to the capsule with the arm positioned in neutral. The graft is placed in a extra-articular fashion with capsular closure to the native glenoid rim.
    Intervention: Procedure: Open Latarjet procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Recurrent anterior instability (dislocation or subluxation) with or without hyperlaxity, including a clinical history of traumatic anterior instability of the shoulder, with positive apprehension or relocation tests.
  2. Provide consent

Exclusion Criteria:

  1. Patients with a concomitant rotator cuff lesion or humeral avulsion of the anteroinferior glenohumeral ligament (HAGL)
  2. An acute first-time dislocation
  3. Previous shoulder surgery
  4. Surgery for a painful, unstable shoulder without true dislocation or subluxation
  5. Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
  6. Active joint or systemic infection
  7. Patients with convulsive disorders, collagen diseases, previous shoulder surgeries, and any other conditions that might affect the mobility of the joint
  8. Major medical illness (life expectancy less than 2 years or unacceptably high operative risk)
  9. Unable to speak or read English/French
  10. Inability to provide informed consent and comply with requirements of participation
  11. Unwilling to be followed for 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060227
Other Study ID Numbers  ICMJE 2013-0704
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Lapner, MD The Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP