Anterior Shoulder InstabilityNCT02060227
Approach to Shoulder Instability
A study testing Open Latarjet procedure and Arthroscopic Bankart repair in people with Anterior Shoulder Instability, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Shoulder Instability
- What is being tested?
- Open Latarjet procedure and Arthroscopic Bankart repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Mar 2014to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Pan Am Clinic Foundation
Winnipeg, Manitoba, R3M 3E4
About this study
Official title: Approach to Shoulder Instability: a Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Anterior Shoulder Instability
- Being tested
- Open Latarjet procedure, Arthroscopic Bankart repair
- Keywords
- Latarjet, Bankart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Latarjet procedureProcedure or surgery
Arthroscopic Bankart repairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open Latarjet procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to up until 24-Months Post-Operative
Secondary outcomes (3)
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.
Measured: From baseline to up until 24-Months Post-Operative
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.
Measured: From baseline to up until 24-Months Post-Operative
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.
Measured: From time of enrollment up until 2-years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start5 Mar 2014
- Primary completionDec 2023
- Study completionApr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060227
- Sponsor's protocol ID
- 20130704-01H
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2014
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach to Shoulder Instability: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02060227
- Acronym / sponsor ID
- 20130704-01H
- Conditions
- Anterior Shoulder Instability
- Keywords
- Latarjet, Bankart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 5 Mar 2014 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Bankart repair | Active comparator | Procedure: Arthroscopic Bankart repairAfter 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. |
| Open Latarjet procedure | Active comparator | Procedure: Open Latarjet procedureA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Latarjet procedure | Procedure or surgery | Open Latarjet procedure |
| Arthroscopic Bankart repair | Procedure or surgery | Arthroscopic Bankart repair |
Primary outcome
Change in Western Ontario Shoulder Instability Index (WOSI)
Time frame: From baseline to up until 24-Months Post-Operative
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.
3 secondary outcomes
Change in The American Shoulder and Elbow Surgeon's (ASES)
Time frame: From baseline to up until 24-Months Post-Operative
Change in Arthritis Progression
Time frame: From baseline to up until 24-Months Post-Operative
Adverse Events
Time frame: From time of enrollment up until 2-years post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Anterior Shoulder Instability
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
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Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
Anterior Shoulder Instability
Recruiting
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
Recurrent Anterior Shoulder Instability
Active, not recruiting
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lapner, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Latarjet procedure and Arthroscopic Bankart repair in people with Anterior Shoulder Instability, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario Shoulder Instability Index (WOSI) (time frame: From baseline to up until 24-Months Post-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.