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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bankart Lesion; Shoulder Instability; Anterior Shoulder Dislocation; Hill Sach Lesion; Shoulder Dislocation Closed Traumatic; First Time Shoulder Dislocation

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Tea Berge; Phone Number: +47 95751146; Email: teaberge@gmail.com
• Study Contact Backup: Name: Martine Enger; Phone Number: + 47 93035414; Email: uxrten@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital
    • Contact: Martine Enger; Phone Number: +47 93035414; Email: uxrten@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Traumatic first time anterior shoulder dislocators; 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 and followed longitudinally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment through completion of inclusion, an average of 2 years
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)	Baseline
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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment, data analysis and questionnaire after 3 and 12 months, 2, 5 and 10 years
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.	3 months, 1 year, 2 year, 5 year and 10 years after first time shoulder dislocation
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	10 years after first time shoulder dislocation
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.	3 months, 1, 2, 5 years and 10 years
Shoulder pain intensity	Shoulder pain intensity measured using the Visual Analogue Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.	3 months, 1 year, 2 years, 5 years and 10 years
Shoulder function (Rowe Score)	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.	3 months and 10 years
Return to sport	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.	3 months, 1 year, 2, 5 years and 10 years
EQ-VAS	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).	3 months, 1,2,5 and 10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Publications and helpful links

General Publications

• Wasserstein DN, Sheth U, Colbenson K, et al. The True Recurrence Rate and Factors Predicting Recurrent Instability After Nonsurgical Management of Traumatic Primary Anterior Shoulder Dislocation: A Systematic Review. Arthroscopy. 2016;32(12):2616-2625.
• Rutgers C, Verweij LPE, Priester-Vink S, et al. Recurrence in traumatic anterior shoulder dislocations increases the prevalence of Hill-Sachs and Bankart lesions: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022;30(6):2130-2140.
• Olds M, Ellis R, Donaldson K, Parmar P, Kersten P. Risk factors which predispose first-time traumatic anterior shoulder dislocations to recurrent instability in adults: a systematic review and meta-analysis. Br J Sports Med. 2015;49(14):913-922.
• Nakagawa S, Iuchi R, Hanai H, Hirose T, Mae T. The Development Process of Bipolar Bone Defects From Primary to Recurrent Instability in Shoulders With Traumatic Anterior Instability. Am J Sports Med. 2019;47(3):695-703.
• Liavaag S, Svenningsen S, Reikerås O, et al. The epidemiology of shoulder dislocations in Oslo. Scand J Med Sci Sports. 2011;21(6):e334-340.
• Hurley ET, Manjunath AK, Bloom DA, et al. Arthroscopic Bankart Repair Versus Conservative Management for First-Time Traumatic Anterior Shoulder Instability: A Systematic Review and Meta-analysis. Arthroscopy. 2020;36(9):2526-2532.
• Enger M, Skjaker SA, Nordsletten L, et al. Sports-related acute shoulder injuries in an urban population. BMJ Open Sport Exerc Med. 2019;5(1):e000551.
• Dickens JF, Slaven SE, Cameron KL, et al. Prospective Evaluation of Glenoid Bone Loss After First-time and Recurrent Anterior Glenohumeral Instability Events. Am J Sports Med. 2019;47(5):1082-1089.
• Di Giacomo G, Itoi E, Burkhart SS. Evolving concept of bipolar bone loss and the Hill-Sachs lesion: from "engaging/non-engaging" lesion to "on-track/off-track" lesion. Arthroscopy. 2014;30(1):90-98.
• Delage Royle A, Balg F, Bouliane MJ, et al. Indication for Computed Tomography Scan in Shoulder Instability: Sensitivity and Specificity of Standard Radiographs to Predict Bone Defects After Traumatic Anterior Glenohumeral Instability. Orthop J Sports Med. 2017;5(10):2325967117733660.
• Belk JW, Wharton BR, Houck DA, et al. Shoulder Stabilization Versus Immobilization for First-Time Anterior Shoulder Dislocation: A Systematic Review and Meta-analysis of Level 1 Randomized Controlled Trials. Am J Sports Med. 2023;51(6):1634-1643.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): April 1, 2037

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Recurrence; prospective; Bone loss; Shoulder instability; First time shoulder dislocation; Primary shoulder dislocation; traumatic anterior shoulder dislocation
• Additional Relevant MeSH Terms: Shoulder Injuries; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Metabolic Diseases; Fractures, Bone; Shoulder Fractures; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Bankart Lesions; Recurrence; Bone Diseases, Metabolic
• Other Study ID Numbers: 24/07976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data are stored in a secure research database (TSD, University of Oslo) containing sensitive health information. De-identified data may be considered for sharing with other researchers upon reasonable request and subject to approval by the data protection authorities and the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No