Approach to Shoulder Instability

Anterior Shoulder Instability Clinical Trial

Official title:

Approach to Shoulder Instability: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060227
• Other study ID #: 20130704-01H
• Status: Completed
• Phase: N/A
• Start date: March 5, 2014
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Instability
• Joint Instability

Intervention

Procedure:
• Open Latarjet procedure

• Arthroscopic Bankart repair

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Pan Am Clinic Foundation	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to up until 24-Months Post-Operative
Secondary	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.	From baseline to up until 24-Months Post-Operative
Secondary	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.	From baseline to up until 24-Months Post-Operative
Secondary	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.	From time of enrollment up until 2-years post-operative