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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All eligible patients presenting with first-time anterior shoulder dislocation at Oslo Accident and Emergency Outpatient Clinic (Oslo University Hospital, OUS) during the inclusion period will be asked to participate.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 1 trial group
Group A: Traumatic first time anterior shoulder dislocators

Trial outcomes

Primary outcomes

1

Epidemiology of first time shoulder dislocations in Oslo, Norway

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

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

Prevalence of bipolar bone loss assessed by CT

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

Time frame
Baseline
3

Prevalence of soft tissue injury assessed by MRI

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

Time frame
Baseline

Secondary outcomes

1

Recurrence of instability after first time shoulder dislocation

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.

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

Patient reported outcomes and shoulder function (WOSI)

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.

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

Glenohumeral osteoarthritis 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

Time frame
10 years after first time shoulder dislocation
4

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

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.

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

Other outcomes

Sponsors and contacts

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