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

NCT05151965 | Recruiting

• 1 other identifier: B2021:094
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  24 months

Secondary Outcomes (6)

• Isokinetic Internal and External Rotation

  24 months

• Athletic Shoulder (ASH) Test

  24 months

• Seated medicine ball toss

  24 months

• Posterior Shoulder Endurance Test

  24 months

• Plyometric Push up

  24 months

Other Outcomes (9)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)

  24 months

• Single Assessment Numeric Evaluation (SANE) score

  24 months

• EuroQol-5D (EQ-5D) + Visual Analog Scale (VAS)

  24 months

Study Arms (2)

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.

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

Procedure: Latarjet Coracoid Transfer

Interventions

Bankart Repair and Remplissage 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.

Bankart Repair and Remplissage

Latarjet Coracoid Transfer 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.

Latarjet Coracoid Transfer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

Study Officials

• Dan Ogborn, PhD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Ogborn, PhD

CONTACT

204-927-2829; dogborn@panamclinic.com

Sheila McRae, PhD

CONTACT

204-925-7469; smcrae@panamclinic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: September 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)