Recruiting

Observational Study

Sponsor:

Panam Clinic

Code:

NCT05151965

Conditions

Anterior Shoulder Dislocation

Anterior Shoulder Instability

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Bankart Repair and Remplissage

Latarjet Coracoid Transfer

Study Details

Brief 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.

Conditions

Anterior Shoulder Dislocation

Anterior Shoulder Instability

Study ID

NCT05151965

Start date

Sep 1, 2022

Status verified date

Apr, 2024

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

Interventions

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.

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.

Primary outcome measure

  • Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 24 months ]
  • Shoulder dislocation and recurrence [ Time Frame: 24 months ]
  • Surgical complications, re-operations and revision surgeries [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Dan Ogborn, PhD

204-927-2829dogborn@panamclinic.com

Sheila McRae, PhD

204-925-7469smcrae@panamclinic.com

Locations

Pan Am Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3M 3E4

Contacts

Dan Ogborn, PhD

204-927-2829dogborn@panamclinic.com

More Information

Sponsor

Panam Clinic

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Keywords

  • Bankart repair
  • Remplissage
  • Latarjet Coracoid Transfer
  • Return to sport

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Panam Clinic on 2024-04-02.