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NCT Number: NCT07486440

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥16 years
  • Diagnosis of first-time traumatic anterior shoulder dislocation
  • Resident in the Oslo region who presents to Oslo Accident and Emergency Outpatient Clinic for treatment or follow-up within two weeks after initial injury
  • Ability to provide informed consent

Exclusion criteria

  • Previous shoulder dislocation requiring reduction (Patients uncertain about prior dislocation are excluded)
  • Age < 16 years
  • Chronic substance abuse affecting compliance
  • Inability to understand Norwegian or English
  • Adult not able to provide consent or severe medical or psychiatric condition precluding follow-up

Treatment and study plan

Primary outcomes

  1. Epidemiology of first time shoulder dislocations in Oslo, Norway

    Time frame: From enrollment through completion of inclusion, an average of 2 years

    Incidence of first-time anterior shoulder dislocations in the Oslo region and prevalence of bipolar bone loss and soft tissue injuries assessed by CT and MRI

  2. Prevalence of bipolar bone loss assessed by CT

    Time frame: Baseline

    Presence and extent of bipolar bone loss (glenoid bone loss and Hill-Sachs lesion) assessed using computed tomography (CT)

  3. Prevalence of soft tissue injury assessed by MRI

    Time frame: Baseline

    Presence of soft tissue injuries (e.g., Bankart lesion, ALPSA lesion, HAGL lesion, SLAP lesion, rotator cuff injury) assessed using magnetic resonance imaging (MRI).

Secondary outcomes

  1. Recurrence of instability after first time shoulder dislocation

    Time frame: From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years

    Prevalence of recurrent instability after first time shoulder dislocation, defined as glenohumeral redislocation requiring reduction. To identify clinical, demographic, and imaging-related risk factors, especially bipolar bone loss, for recurrent instability.

  2. Patient reported outcomes and shoulder function (WOSI)

    Time frame: 3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation

    Patient-reported shoulder function measured using the Western Ontario Shoulder Instability Index (WOSI) score. The WOSI score ranges from 0 to 2100, where lower scores indicate better shoulder function and quality of life. Scores may be converted to a percentage scale ranging from 0-100%, where higher scores indicate better shoulder function and quality of life.

  3. Glenohumeral osteoarthritis after first time shoulder dislocation

    Time frame: 10 years after first time shoulder dislocation

    To evaluate radiographic signs of glenohumeral osteoarthritis at 10-year follow-up and examine their association with recurrence and baseline bone loss

  4. Health-related quality of life (EQ-5D-5L)

    Time frame: 3 months, 1, 2, 5 years and 10 years

    Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Responses from the five dimensions will be converted into an EQ-5D-5L index score using the Norwegian value set. The index score ranges from less than 0 (health states worse than death) to 1 (perfect health), where higher scores indicate better health-related quality of life.

  5. Shoulder pain intensity

    Time frame: 3 months, 1 year, 2 years, 5 years and 10 years

    Shoulder pain intensity measured using the Visual Analogue Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.

  6. Shoulder function (Rowe Score)

    Time frame: 3 months and 10 years

    To measure general shoulder function included pain, stability, range and function using the Rowe Score, ranging from 0 to 100, where higher scores indicate better shoulder stability and function.

  7. Return to sport

    Time frame: 3 months, 1 year, 2, 5 years and 10 years

    Return to sport after first-time shoulder dislocation assessed using a patient questionnaire evaluating whether the participant has returned to sport and at what level compared with pre-injury activity.

  8. EQ-VAS

    Time frame: 3 months, 1,2,5 and 10 years

    EQ-VAS is a self-reported health status measured using the EQ-5D visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).

Study contacts

Contact information is provided by the study sponsor or research team.

Martine Enger

CONTACT

[email protected]

+ 47 93035414

Tea Berge

CONTACT

[email protected]

+47 95751146

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: SALTO

Important dates

Study start
2026
Primary completion
2029
Study completion
2037
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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