Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Approach to Shoulder Instability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Anterior Shoulder Instability Procedure: Open Latarjet procedure Procedure: Arthroscopic Bankart repair Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Approach to Shoulder Instability: a Randomized, Controlled Trial
Actual Study Start Date : March 5, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
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.
Procedure: Open Latarjet procedure



Primary Outcome Measures :
  1. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. The American Shoulder and Elbow Surgeon's (ASES) [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060227


Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Peter Lapner, MD    6137378899 ext 78377    plapner@toh.on.ca   
Principal Investigator: Peter Lapner, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Peter Lapner, MD The Ottawa Hospital

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02060227     History of Changes
Other Study ID Numbers: 2013-0704
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Instability
Joint Diseases
Musculoskeletal Diseases