Anterior Shoulder DislocationNCT05151965
Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability
An observational study of Anterior Shoulder Dislocation and Anterior Shoulder Instability, run by Panam Clinic at 1 site in Canada.
Trial summary
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Shoulder Dislocation, Anterior Shoulder Instability
- What is being tested?
- Bankart Repair and Remplissage and Latarjet Coracoid Transfer
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 1 Apr 2026
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18 - 50 years who have documented reduction of anterior shoulder dislocation. The participant has suffered two or more dislocations of the study shoulder, and the physical examination elicits unwanted glenohumeral translation with reproduction of symptoms. The participant has glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25%, and would benefit from surgical intervention.
Who may be able to join
- Aged 18 - 50 years
- Documented reduction of anterior shoulder dislocation
- Patient has suffered two or more dislocations of the study shoulder
- Physical examination elicits unwanted glenohumeral translation with reproduction of symptoms
- Glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25%
- Able to benefit from surgical intervention
Who cannot join
- Glenoid defect in the affected shoulder ≥ 25% of the AP diameter of the glenoid
- Previous surgery on affected shoulder (ANY type of shoulder surgery)
- Significant shoulder comorbidities including osteoarthritis or other shoulder conditions including multi-directional instability
- Participant is involved in litigation or a workplace insurance claim (i.e., WCB).
- Confirmed connective tissue disorder (i.e., Ehlers-Danlos, Marfans)
- Beighton hypermobility score of >6
Show all 12Show fewer
- Active joint or systemic infection, significant muscle paralysis, rotator cuff tear arthropathy, Charcot's arthropathy, significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
- Major medical illness (life expectancy less than 1 year) or unacceptably high operative risk
- Epilepsy
- Any condition that precludes informed consent (i.e. psychiatric illness)
- Unable to speak or read English/French
- Unable or unwilling to be followed for 2 years or complete functional testing
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
Dan Ogborn, PhD, 204-927-2829, dogborn@panamclinic.com
About this study
Official title: Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability (AGHI)
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.
Read the detailed description
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of AGHI up to 24-months postoperative. A secondary objective aims to address rates of return to sport (RTS) and performance in an RTS assessment in athletic patients with anterior glenohumeral instability (AGHI) who elect to undergo either surgical intervention until 24-months postoperative.
- Being tested
- Bankart Repair and Remplissage, Latarjet Coracoid Transfer
- Keywords
- Bankart repair, Remplissage, Latarjet Coracoid Transfer, Return to sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bankart Repair and RemplissageProcedure or surgery
Arthroscopic Bankart repair with a minimum of 3 anchors
1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.
Latarjet Coracoid TransferProcedure or surgery
Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.
| Study group | Role | What they receive |
|---|---|---|
| Bankart Repair and Remplissage | Patients will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon. Receives: Procedure: Bankart Repair and Remplissage | |
| Latarjet Coracoid Transfer | Patients will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws Receives: Procedure: Latarjet Coracoid Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability Index (WOSI)
Is a disease specific, quality of life patient reported outcome measures (PROMS) for patients with shoulder instability. Patients use visual analog scales (VAS) to rate physical symptoms and impacts of the condition/treatment on sports/recreation/work, lifestyle, and emotions.
Measured: 24 months
Shoulder dislocation and recurrence
Dislocation requiring reduction by a physician (ED) or surgery. Dislocations will be identified in two ways: 1) if the patient seeks treatment from the surgeon, the surgeon will notify the research coordinator who will document it accordingly, or 2) at each research postoperative examination, the research staff will ask patients if they experienced a dislocation or subluxation. These will be considered alongside the definition of recurrence from Kasik et al. that also includes subluxation, or positive findings during physical examination for shoulder instability (apprehension).
Measured: 24 months
Surgical complications, re-operations and revision surgeries
Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (Sokol and Wilson, 2008) (i.e., infection, dislocation, neurological injury, and fracture (including periprosthetic and acromial fracture).
Revision surgery and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. Revision is defined as a change of an original component (partial or complete replacement). Re-operation is defined as any surgical procedure other than a revision.
Measured: 24 months
Secondary outcomes (6)
Isokinetic Internal and External Rotation
Internal and external rotation strength will be determined with an isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA). With the arm in 90 degrees shoulder abduction and elbow flexion and positioned in the scapular plane, patients will complete coupled concentric and eccentric shoulder internal and external rotation within a 90 degrees range of motion (-40 degrees internal rotation to 50 degrees external rotations). Three maximal effort (instructed to contract as hard and as fast as they can) repetitions will be completed at velocities of 60 and 180 degrees per second, with one-minute rest between testing speeds. Average peak torque of the three repetitions will be recorded for both IR and ER.
Measured: 24 months
Athletic Shoulder (ASH) Test
The patient Is positioned prone with a foam block in place to support their forehand. The test is completed in three positions termed "I", with the arm positioned in 180 degrees of shoulder flexion, "Y, with the arm positioned in 135 degrees of shoulder abduction, and "T", with the arm positioned in 90 degrees of abduction. In each position, the palm of the hand rests on a force plate (AMTI, MA, USA). The patient will complete a warm-up of two submaximal attempts in each position to 80-90% maximal effort, then three maximal effort trials for each limb in each test position (I, Y, T), with 20 seconds rest between repetitions. For each repetition, subjects will be instructed to push against the plate as hard and as fast as possible for three seconds. Peak and mean force across the three attempts and positions will be recorded.
Measured: 24 months
Seated medicine ball toss
The patient will start the test in the seated position with the legs extended in front of their body, and the head, shoulders and back firmly against a wall. They will then attempt a "chest pass" by throwing a 10 lbs. medicine ball as far as they can. Four trials will be completed with 30 sec rest between each trial. Maximum distance will be recorded and averaged, once adjusted for arm length (distance of the ball from the wall with the arm held at 90 degrees of flexion and full elbow extension).
Measured: 24 months
Posterior Shoulder Endurance Test
The patient starts positioned in prone towards one edge of a plinth, with the arm held in 90o shoulder flexion, perpendicular to the floor. Holding a weight of 2% of total body weight, the patient will attempt to raise the weight to 90 degrees of horizontal abduction, holding for one second at this position before returning to the starting position (tempo of 30 bpm). The test is terminated when the patient is fatigued as indicated by 1) the inability to hold the mid position for one second and 2) using compensatory movements of the torso, or patient request to terminate.
Measured: 24 months
Plyometric Push up
Participants will start in a push up position with each hand extended in front of the shoulders and positioned on an individual force plate. When cued, the participant will lower their body to the ground by flexing at the elbow until their sternum is 3 cm from the floor. They will then forcefully extend at the elbow and propel their body into the air above the plate. During landing, the subjects will be instructed to reduce the impact as much as possible and continue for two additional repetitions. Three repetitions will be completed. Peak ground reaction forces during impact, peak rate of force development (RFD) during the concentric phase will be averaged from the three repetitions and expressed as a limb symmetry index (injured/uninjured * 100%).
Measured: 24 months
Single arm seated shot put
The patient will start seated in an 18" chair without arm rests, with the legs positioned in front of their body, extended to rest straight onto an additional chair. The non-throwing arm will be placed across the chest, with a strap placed diagonally around the upper body to secure the subject to the chair. The patient will "put" (like shot put), and not "throw" (like baseball) the 6 lb. ball from shoulder height for maximal distance. Three maximal effort attempts will be recorded after a graded warm-up of four "puts" at 25, 50, 75 and 100% estimated effort. Thirty seconds rest will be provided between maximal attempts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Sep 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Shoulder DislocationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Ogborn, PhD, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151965
- Sponsor's protocol ID
- B2021:094
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability (AGHI)
- ClinicalTrials.gov ID
- NCT05151965
- Acronym / sponsor ID
- B2021:094
- Keywords
- Bankart repair, Remplissage, Latarjet Coracoid Transfer, Return to sport
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Dec 2021 (actual)
- 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 purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.
Detailed description
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of AGHI up to 24-months postoperative. A secondary objective aims to address rates of return to sport (RTS) and performance in an RTS assessment in athletic patients with anterior glenohumeral instability (AGHI) who elect to undergo either surgical intervention until 24-months postoperative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bankart Repair and Remplissage | – | Procedure: Bankart Repair and RemplissagePatients will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon. |
| Latarjet Coracoid Transfer | – | Procedure: Latarjet Coracoid TransferPatients will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18 - 50 years who have documented reduction of anterior shoulder dislocation. The participant has suffered two or more dislocations of the study shoulder, and the physical examination elicits unwanted glenohumeral translation with reproduction of symptoms. The participant has glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25%, and would benefit from surgical intervention.
Key inclusion criteria (6 listed)
- Aged 18 - 50 years
- Documented reduction of anterior shoulder dislocation
- Patient has suffered two or more dislocations of the study shoulder
- Physical examination elicits unwanted glenohumeral translation with reproduction of symptoms
- Glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25%
Key exclusion criteria (12 listed)
- Glenoid defect in the affected shoulder ≥ 25% of the AP diameter of the glenoid
- Previous surgery on affected shoulder (ANY type of shoulder surgery)
- Significant shoulder comorbidities including osteoarthritis or other shoulder conditions including multi-directional instability
- Participant is involved in litigation or a workplace insurance claim (i.e., WCB).
- Confirmed connective tissue disorder (i.e., Ehlers-Danlos, Marfans)
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 |
|---|---|---|
| Bankart Repair and RemplissageArthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space. | Procedure or surgery | Bankart Repair and Remplissage |
| Latarjet Coracoid TransferCoracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim. | Procedure or surgery | Latarjet Coracoid Transfer |
Primary outcome
Western Ontario Shoulder Instability Index (WOSI)
Time frame: 24 months
Is a disease specific, quality of life patient reported outcome measures (PROMS) for patients with shoulder instability. Patients use visual analog scales (VAS) to rate physical symptoms and impacts of the condition/treatment on sports/recreation/work, lifestyle, and emotions.
Shoulder dislocation and recurrence
Time frame: 24 months
Dislocation requiring reduction by a physician (ED) or surgery. Dislocations will be identified in two ways: 1) if the patient seeks treatment from the surgeon, the surgeon will notify the research coordinator who will document it accordingly, or 2) at each research postoperative examination, the research staff will ask patients if they experienced a dislocation or subluxation. These will be considered alongside the definition of recurrence from Kasik et al. that also includes subluxation, or positive findings during physical examination for shoulder instability (apprehension).
Surgical complications, re-operations and revision surgeries
Time frame: 24 months
Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (Sokol and Wilson, 2008) (i.e., infection, dislocation, neurological injury, and fracture (including periprosthetic and acromial fracture). Revision surgery and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. Revision is defined as a change of an original component (partial or complete replacement). Re-operation is defined as any surgical procedure other than a revision.
6 secondary outcomes
Isokinetic Internal and External Rotation
Time frame: 24 months
Athletic Shoulder (ASH) Test
Time frame: 24 months
Seated medicine ball toss
Time frame: 24 months
Posterior Shoulder Endurance Test
Time frame: 24 months
Plyometric Push up
Time frame: 24 months
Single arm seated shot put
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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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.
Dan Ogborn, PhD principal investigator
Pan Am Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Shoulder Dislocation and Anterior Shoulder Instability, run by Panam Clinic at 1 site 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Ogborn, PhD (204-927-2829, dogborn@panamclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability Index (WOSI) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 2 Apr 2024.