Approach to Shoulder Instability

NCT02060227 | Completed

• 1 other identifier: 20130704-01H
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Shoulder Instability

Keywords

Latarjet; Bankart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in The American Shoulder and Elbow Surgeon's (ASES)

  From baseline to up until 24-Months Post-Operative

• Change in Arthritis Progression

  From baseline to up until 24-Months Post-Operative

• Adverse Events

  From time of enrollment up until 2-years post-operative

Study Arms (2)

Arthroscopic Bankart repair

ACTIVE COMPARATOR

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

Open Latarjet procedure

ACTIVE COMPARATOR

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

Interventions

Open Latarjet procedure PROCEDURE

Open Latarjet procedure

Arthroscopic Bankart repair PROCEDURE

Arthroscopic Bankart repair

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

Pan Am Clinic Foundation

Winnipeg, Manitoba, R3M 3E4, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Study Officials

• Peter Lapner, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: February 12, 2014
• Study Start: March 5, 2014
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)