Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability

NCT ID: NCT05151965

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Anterior Shoulder Dislocation Anterior Shoulder Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bankart Repair and Remplissage

Intervention Type PROCEDURE

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 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

Latarjet Coracoid Transfer

Intervention Type PROCEDURE

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.

Interventions

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Bankart Repair and Remplissage

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.

Intervention Type PROCEDURE

Latarjet Coracoid Transfer

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Panam Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Ogborn, PhD

Role: PRINCIPAL_INVESTIGATOR

Pan Am Clinic

Locations

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Pan Am Clinic

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dan Ogborn, PhD

Role: CONTACT

204-927-2829

Sheila McRae, PhD

Role: CONTACT

204-925-7469

Facility Contacts

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Dan Ogborn, PhD

Role: primary

204-927-2829

Other Identifiers

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B2021:094

Identifier Type: -

Identifier Source: org_study_id

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