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Approach to Shoulder Instability

Primary Purpose

Anterior Shoulder Instability

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Open Latarjet procedure
Arthroscopic Bankart repair
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Shoulder Instability focused on measuring Latarjet, Bankart

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pan Am Clinic Foundation
  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arthroscopic Bankart repair

Open Latarjet procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOSI is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

Secondary Outcome Measures

Change in The American Shoulder and Elbow Surgeon's (ASES)
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Change in Arthritis Progression
Radiological parameters will be examined using x-rays. These images will be analyzed for abnormalities by a Musculoskeletal Radiologist. Higher abnormality incidence indicates worse outcomes.
Adverse Events
Rates of study adverse events or serious adverse events (e.g. number of re-operations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.

Full Information

First Posted
January 21, 2014
Last Updated
March 2, 2023
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02060227
Brief Title
Approach to Shoulder Instability
Official Title
Approach to Shoulder Instability: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2014 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
The bony architecture of the glenohumeral joint is often likened to that of a golf ball and tee. This geometry provides a functional benefit by allowing for a large arc of motion, but also confers an inherent instability that can result in traumatic anterior shoulder dislocation. By far the most common type of glenohumeral instability is anterior dislocation, accounting for over 90% of all shoulder dislocations. The glenohumeral joint relies on a complex network of static and dynamic structures that aid in stabilizing the joint. Compromise of these structures leads to dislocation and often, recurrent instability. Structures providing static stability to the glenohumeral joint include the congruency of the humeral head and glenoid, the glenoid labrum, glenohumeral ligaments surrounding the joint, and negative intra-articular pressure. Dynamic stabilizers are primarily muscular and include the rotator cuff, which provides a compressive stabilizing effect, the tendon of the long head of the biceps, and muscles that stabilize the scapula. The current accepted "standard" protocol depends on the amount of glenoid bone loss. Typically, when there is little bone loss, the treatment of anterior recurrent instability involves Bankart arthroscopic stabilization. In the setting of significant glenoid bone loss (>25%), the Latarjet technique involving bone grafting of the glenoid defect is indicated in order to address the aforementioned higher risk of recurrence in this setting. Balg and Boileau proposed a comprehensive score in 2007 including: age at surgery, degree of sport participation (pre-operative), type of sport (pre-operative), shoulder hyperlaxity, Hill-Sachs on AP radiograph and glenoid loss of contour on AP radiograph at the first consultation: the Instability Severity Index Score (ISIS). In contrast to the standard treatment protocol, the authors propose that an ISIS ≦3 points is an indication for arthroscopic Bankart repair, and a score of greater than 3 is an indication for a Latarjet procedure (open stabilization with coracoid bone graft). This study would be the first to investigate the ISIS decision-making algorithm, an exciting and novel approach to the treatment of shoulder instability, and to compare it to the conventional treatment algorithm within the framework of a prospective, randomized controlled study. If the new ISIS decision-making algorithm proves to be effective at decreasing recurrence instability rates, improving function and quality of life, while maintaining low complication rates, it has the potential to lead to widespread practice change within the Orthopaedic community in North America and abroad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Instability
Keywords
Latarjet, Bankart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic Bankart repair
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Open Latarjet procedure
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Open Latarjet procedure
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Bankart repair
Primary Outcome Measure Information:
Title
Change in Western Ontario Shoulder Instability Index (WOSI)
Description
The Western Ontario Shoulder Instability Index (WOSI) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOSI is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Time Frame
From baseline to up until 24-Months Post-Operative
Secondary Outcome Measure Information:
Title
Change in The American Shoulder and Elbow Surgeon's (ASES)
Description
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Time Frame
From baseline to up until 24-Months Post-Operative
Title
Change in Arthritis Progression
Description
Radiological parameters will be examined using x-rays. These images will be analyzed for abnormalities by a Musculoskeletal Radiologist. Higher abnormality incidence indicates worse outcomes.
Time Frame
From baseline to up until 24-Months Post-Operative
Title
Adverse Events
Description
Rates of study adverse events or serious adverse events (e.g. number of re-operations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.
Time Frame
From time of enrollment up until 2-years post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Provide consent Exclusion Criteria: Patients with a concomitant rotator cuff lesion or humeral avulsion of the anteroinferior glenohumeral ligament (HAGL) An acute first-time dislocation Previous shoulder surgery Surgery for a painful, unstable shoulder without true dislocation or subluxation Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population) Active joint or systemic infection Patients with convulsive disorders, collagen diseases, previous shoulder surgeries, and any other conditions that might affect the mobility of the joint Major medical illness (life expectancy less than 2 years or unacceptably high operative risk) Unable to speak or read English/French Inability to provide informed consent and comply with requirements of participation Unwilling to be followed for 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lapner, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pan Am Clinic Foundation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Approach to Shoulder Instability

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