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

P

Panam Clinic

Status

Enrolling

Conditions

Anterior Shoulder Instability
Anterior Shoulder Dislocation

Treatments

Procedure: Latarjet Coracoid Transfer
Procedure: Bankart Repair and Remplissage

Study type

Observational

Funder types

Other

Identifiers

NCT05151965
B2021:094

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Bankart Repair and Remplissage
Description:
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.
Treatment:
Procedure: Bankart Repair and Remplissage
Latarjet Coracoid Transfer
Description:
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
Treatment:
Procedure: Latarjet Coracoid Transfer

Trial contacts and locations

1

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Central trial contact

Sheila McRae, PhD; Dan Ogborn, PhD

Data sourced from clinicaltrials.gov

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