Clinical trial NCT05151965: Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability
Official title: Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability (AGHI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Shoulder Dislocation
Anterior Shoulder Instability
Keywords: Bankart repair
Remplissage
Latarjet Coracoid Transfer
Return to sport
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 24 months
measure: Shoulder dislocation and recurrence
timeFrame: 24 months
measure: Surgical complications, re-operations and revision surgeries
timeFrame: 24 months
Secondary outcomes:
measure: Isokinetic Internal and External Rotation
timeFrame: 24 months
measure: Athletic Shoulder (ASH) Test
timeFrame: 24 months
measure: Seated medicine ball toss
timeFrame: 24 months
measure: Posterior Shoulder Endurance Test
timeFrame: 24 months
measure: Plyometric Push up
timeFrame: 24 months
measure: Single arm seated shot put
timeFrame: 24 months
Other outcomes:
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
timeFrame: 24 months
measure: Single Assessment Numeric Evaluation (SANE) score
timeFrame: 24 months
measure: EuroQol-5D (EQ-5D) + Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Shoulder activity scale (SAS)
timeFrame: 24 months
measure: Postoperative Pain and Medication Use
timeFrame: 3 weeks
measure: Subjective Patient Outcome for Return to Sports (SPORTS)
timeFrame: 24 months
measure: Shoulder Instability Return to Sport (SIRSI)
timeFrame: 24 months
measure: Waterloo Handedness Questionnaire (WHQ)
timeFrame: 24 months
measure: Closed Kinetic Chain Upper Extremity Stability Test
timeFrame: 24 months
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: Pan Am Clinic
name: Dan Ogborn, PhD
role: PRINCIPAL_INVESTIGATOR
References: