NCT07486440

Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)

SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective observational cohort study is to provide epidemiological and prognostic data from a defined urban population and to improve understanding of risk factors and long-term outcomes following first-time anterior shoulder dislocation in patients aged 16 years and older presenting to the Oslo Accident and Emergency Outpatient Clinic. The main questions the study aims to answer are: * What is the incidence of first-time anterior shoulder dislocations in the Oslo region? * What is the prevalence and extent of bipolar bone loss and soft tissue injuries measured by CT and MR after a first-time shoulder dislocation? * Does bone loss increase the risk of recurrent shoulder instability? * How do imaging findings and recurrence influence long-term shoulder function and quality of life? Participants will: * Undergo standard clinical evaluation and conventional radiographs as part of routine care and asked to participate and followed longitudinally * Be offered additional CT and MRI imaging to assess glenoid and humeral bone loss and to evaluate soft tissue injuries. * Complete electronic questionnaires (WOSI, EQ-5D-5L, pain score, Rowe score, return to sport/work) at 3 months, 1 year, 5 years, and 10 years. * Be invited to long-term follow-up, including radiographs at 10 years to evaluate signs of osteoarthritis.

Detailed description

Traumatic anterior shoulder dislocation is a common injury, particularly among young and active individuals. Recurrence after a first-time anterior dislocation is frequent and varies substantially depending on age, activity level, and structural injury. Established risk factors include young age, male sex, hyperlaxity, participation in contact or overhead sports and concomitant bony or soft tissue injury. Despite the high recurrence risk in selected patient groups, most first-time dislocators are treated non-operatively in current Norwegian practice. Subtle bony defects may be underdiagnosed on plain radiographs. Approximately one-third of patients sustain a bony Bankart lesion, and more than 70% present with a Hill-Sachs lesion. The size and location of the Hill-Sachs lesion, as well as its on-track/off-track classification, have implications for treatment strategy. CT with three-dimensional reconstruction is considered the most reliable method for assessing glenoid and humeral bone loss, while MRI enables detailed evaluation of associated soft tissue injuries, including labral and capsuloligamentous lesions. The SALTO study is a prospective observational cohort including all eligible patients aged ≥16 years presenting with first-time anterior shoulder dislocation at a defined urban emergency clinic. The study will systematically assess bone loss using CT and characterize soft tissue injuries using MRI. Patients will be followed longitudinally with clinical data and patient-reported outcome measures to evaluate recurrence, shoulder function, and long-term shoulder function. By correlating imaging findings with recurrent instability and long-term outcomes, the study aims to improve risk stratification after first-time anterior shoulder dislocation and identify patients who may benefit from early surgical intervention.

Conditions

• Anterior Shoulder Dislocation
• Shoulder Dislocation Closed Traumatic
• First Time Shoulder Dislocation
• Shoulder Instability
• Hill Sach Lesion
• Bankart Lesion

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-04-15
• Completion: 2037-04-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Norway